Trial Outcomes & Findings for Study of ASP7517 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors Expressing WT1 Antigen (NCT NCT04837196)
NCT ID: NCT04837196
Last Updated: 2025-08-08
Results Overview
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
24 participants
Primary outcome timeframe
At C3D15
Results posted on
2025-08-08
Participant Flow
Participants aged ≥ 18 years diagnosed with a locally-advanced (unresectable) or metastatic solid tumor known to express Wilms' tumor protein 1 (WT1) antigen were enrolled in this study.
Participants who met all inclusion criteria and none of the exclusion criteria were enrolled in the study. No combination therapy dose expansion arm was enrolled.
Participant milestones
| Measure |
Phase 1:Monotherapy Dose Escalation (ASP7517 1x10^7 Cells/Dose)
Participants received one dose of ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) by intravenous (IV) infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or stable disease \[SD\], or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participant who achieved confirmed complete response (CR) did not continue with ASP7517, and any participants who achieved partial response (PR) or SD received an additional 2 doses. Participants entered an Observation Period except those with "immune" confirmed progressive disease (iCPD), unconfirmed disease progression disease (iUPD) (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the end of treatment (EOT) visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose)
Participants received one dose of ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 2:Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose)
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 1:Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab
Participants received ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by the investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review/local review, entered the Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 1:Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
|---|---|---|---|---|---|
|
Phase 1 Dose Escalation (Up to 817 Days)
STARTED
|
3
|
8
|
0
|
3
|
8
|
|
Phase 1 Dose Escalation (Up to 817 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
1
|
|
Phase 1 Dose Escalation (Up to 817 Days)
NOT COMPLETED
|
3
|
8
|
0
|
3
|
7
|
|
Phase 2 Dose Expansion (Up to 504 Days)
STARTED
|
0
|
0
|
2
|
0
|
0
|
|
Phase 2 Dose Expansion (Up to 504 Days)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2 Dose Expansion (Up to 504 Days)
NOT COMPLETED
|
0
|
0
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
Phase 1:Monotherapy Dose Escalation (ASP7517 1x10^7 Cells/Dose)
Participants received one dose of ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) by intravenous (IV) infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or stable disease \[SD\], or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participant who achieved confirmed complete response (CR) did not continue with ASP7517, and any participants who achieved partial response (PR) or SD received an additional 2 doses. Participants entered an Observation Period except those with "immune" confirmed progressive disease (iCPD), unconfirmed disease progression disease (iUPD) (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the end of treatment (EOT) visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose)
Participants received one dose of ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 2:Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose)
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 1:Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab
Participants received ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by the investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review/local review, entered the Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 1:Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
|---|---|---|---|---|---|
|
Phase 1 Dose Escalation (Up to 817 Days)
Withdrawal by Subject
|
0
|
3
|
0
|
0
|
4
|
|
Phase 1 Dose Escalation (Up to 817 Days)
Progressive Disease
|
3
|
4
|
0
|
3
|
3
|
|
Phase 1 Dose Escalation (Up to 817 Days)
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
|
Phase 2 Dose Expansion (Up to 504 Days)
Progressive Disease
|
0
|
0
|
1
|
0
|
0
|
|
Phase 2 Dose Expansion (Up to 504 Days)
Lack of Efficacy
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Study of ASP7517 Alone and With Pembrolizumab in Participants With Advanced Solid Tumors Expressing WT1 Antigen
Baseline characteristics by cohort
| Measure |
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^7 Cells/Dose)
n=3 Participants
Participants received one dose of ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose)
n=8 Participants
Participants received one dose of ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose)
n=2 Participants
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.)
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab
n=3 Participants
Participants received ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8 Cells/Dose) and Pembrolizumab
n=8 Participants
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
68.7 Years
STANDARD_DEVIATION 16.3 • n=5 Participants
|
51.6 Years
STANDARD_DEVIATION 13.6 • n=7 Participants
|
53.0 Years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
61.3 Years
STANDARD_DEVIATION 4.7 • n=4 Participants
|
61.8 Years
STANDARD_DEVIATION 12.1 • n=21 Participants
|
58.5 Years
STANDARD_DEVIATION 13.1 • n=10 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
13 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
23 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
20 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
Grade 0
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
Grade 1
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
13 Participants
n=10 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
Grade 2
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: From first dose up to 30 days after last dose (maximum treatment duration: approximately 534[504+30] days)Population: SAF
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the study drug. An AE could therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An AE was considered "serious" if, it resulted in any of the following outcomes: resulted in death; was life-threatening; resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions; resulted in congenital anomaly, or birth defect; required inpatient hospitalization; or led to prolongation of hospitalization; other medically important events. A treatment-emergent adverse event (TEAE) was defined as an AE observed after the date of first dose until 30 days after the last dose.
Outcome measures
| Measure |
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^7 Cells/Dose)
n=3 Participants
Participants received one dose of ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose)
n=8 Participants
Participants received one dose of ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose)
n=2 Participants
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.)
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab
Participants received ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events: Monotherapy
TEAEs
|
3 Participants
|
7 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events: Monotherapy
SAEs
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose up to 30 days after last dose (maximum treatment duration: approximately 847[817+30] days)Population: SAF
An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the study drug. An AE could therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An AE was considered "serious" if, it resulted in any of the following outcomes: resulted in death; was life-threatening; resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions; resulted in congenital anomaly, or birth defect; required inpatient hospitalization; or led to prolongation of hospitalization; other medically important events. A treatment-emergent adverse event (TEAE) was defined as an AE observed after the date of first dose until 30 days after the last dose.
Outcome measures
| Measure |
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^7 Cells/Dose)
n=3 Participants
Participants received one dose of ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose)
n=8 Participants
Participants received one dose of ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose)
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.)
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab
Participants received ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events: Combination Therapy
TEAEs
|
3 Participants
|
8 Participants
|
—
|
—
|
—
|
|
Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events: Combination Therapy
SAEs
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At C1D1Population: SAF
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead.
Outcome measures
| Measure |
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^7 Cells/Dose)
n=3 Participants
Participants received one dose of ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose)
n=8 Participants
Participants received one dose of ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose)
n=2 Participants
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.)
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab
n=3 Participants
Participants received ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab
n=8 Participants
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
|---|---|---|---|---|---|
|
Number of Participants With ECOG Performance Status at Cycle (C) 1 Day (D) 1
Grade 0
|
1 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With ECOG Performance Status at Cycle (C) 1 Day (D) 1
Grade 1
|
2 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants With ECOG Performance Status at Cycle (C) 1 Day (D) 1
Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at Cycle (C) 1 Day (D) 1
Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at Cycle (C) 1 Day (D) 1
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at Cycle (C) 1 Day (D) 1
Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At C1D2Population: SAF with available data was analyzed. As per protocol no participants were planned to be enrolled in C1D2 for monotherapy dose expansion therefore, no participants were included in this arm.
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead.
Outcome measures
| Measure |
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^7 Cells/Dose)
n=3 Participants
Participants received one dose of ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose)
n=8 Participants
Participants received one dose of ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose)
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.)
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab
n=3 Participants
Participants received ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab
n=8 Participants
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
|---|---|---|---|---|---|
|
Number of Participants With ECOG Performance Status at C1D2
Grade 0
|
1 Participants
|
3 Participants
|
—
|
1 Participants
|
3 Participants
|
|
Number of Participants With ECOG Performance Status at C1D2
Grade 1
|
2 Participants
|
5 Participants
|
—
|
2 Participants
|
3 Participants
|
|
Number of Participants With ECOG Performance Status at C1D2
Grade 2
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
2 Participants
|
|
Number of Participants With ECOG Performance Status at C1D2
Grade 3
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C1D2
Grade 4
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C1D2
Grade 5
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At C1D4Population: SAF
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead.
Outcome measures
| Measure |
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^7 Cells/Dose)
n=3 Participants
Participants received one dose of ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose)
n=8 Participants
Participants received one dose of ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose)
n=2 Participants
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.)
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab
n=3 Participants
Participants received ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab
n=8 Participants
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
|---|---|---|---|---|---|
|
Number of Participants With ECOG Performance Status at C1D4
Grade 0
|
1 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With ECOG Performance Status at C1D4
Grade 1
|
2 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With ECOG Performance Status at C1D4
Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With ECOG Performance Status at C1D4
Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With ECOG Performance Status at C1D4
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C1D4
Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At C1D8Population: SAF
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead.
Outcome measures
| Measure |
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^7 Cells/Dose)
n=3 Participants
Participants received one dose of ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose)
n=8 Participants
Participants received one dose of ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose)
n=2 Participants
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.)
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab
n=3 Participants
Participants received ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab
n=8 Participants
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
|---|---|---|---|---|---|
|
Number of Participants With ECOG Performance Status at C1D8
Grade 0
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With ECOG Performance Status at C1D8
Grade 1
|
2 Participants
|
5 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants With ECOG Performance Status at C1D8
Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C1D8
Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With ECOG Performance Status at C1D8
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C1D8
Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At C1D15Population: SAF
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead.
Outcome measures
| Measure |
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^7 Cells/Dose)
n=3 Participants
Participants received one dose of ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose)
n=8 Participants
Participants received one dose of ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose)
n=2 Participants
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.)
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab
n=3 Participants
Participants received ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab
n=8 Participants
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
|---|---|---|---|---|---|
|
Number of Participants With ECOG Performance Status at C1D15
Grade 0
|
1 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With ECOG Performance Status at C1D15
Grade 1
|
2 Participants
|
5 Participants
|
1 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants With ECOG Performance Status at C1D15
Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C1D15
Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With ECOG Performance Status at C1D15
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C1D15
Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At C2D1Population: SAF with available data was analyzed.
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead.
Outcome measures
| Measure |
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^7 Cells/Dose)
n=2 Participants
Participants received one dose of ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose)
n=7 Participants
Participants received one dose of ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose)
n=2 Participants
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.)
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab
n=3 Participants
Participants received ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab
n=7 Participants
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
|---|---|---|---|---|---|
|
Number of Participants With ECOG Performance Status at C2D1
Grade 0
|
0 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With ECOG Performance Status at C2D1
Grade 1
|
2 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
|
Number of Participants With ECOG Performance Status at C2D1
Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With ECOG Performance Status at C2D1
Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C2D1
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C2D1
Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At C2D4Population: SAF with available data was analyzed.
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead.
Outcome measures
| Measure |
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^7 Cells/Dose)
n=2 Participants
Participants received one dose of ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose)
n=6 Participants
Participants received one dose of ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose)
n=2 Participants
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.)
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab
n=3 Participants
Participants received ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab
n=6 Participants
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
|---|---|---|---|---|---|
|
Number of Participants With ECOG Performance Status at C2D4
Grade 0
|
0 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With ECOG Performance Status at C2D4
Grade 1
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
|
Number of Participants With ECOG Performance Status at C2D4
Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C2D4
Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C2D4
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C2D4
Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At C2D8Population: SAF with available data was analyzed.
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead.
Outcome measures
| Measure |
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^7 Cells/Dose)
n=2 Participants
Participants received one dose of ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose)
n=5 Participants
Participants received one dose of ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose)
n=2 Participants
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.)
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab
n=3 Participants
Participants received ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab
n=7 Participants
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
|---|---|---|---|---|---|
|
Number of Participants With ECOG Performance Status at C2D8
Grade 0
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With ECOG Performance Status at C2D8
Grade 1
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
|
Number of Participants With ECOG Performance Status at C2D8
Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C2D8
Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With ECOG Performance Status at C2D8
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C2D8
Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At C2D15Population: SAF with available data was analyzed.
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead.
Outcome measures
| Measure |
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^7 Cells/Dose)
n=2 Participants
Participants received one dose of ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose)
n=5 Participants
Participants received one dose of ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose)
n=2 Participants
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.)
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab
n=3 Participants
Participants received ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab
n=6 Participants
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
|---|---|---|---|---|---|
|
Number of Participants With ECOG Performance Status at C2D15
Grade 0
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With ECOG Performance Status at C2D15
Grade 1
|
2 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
|
Number of Participants With ECOG Performance Status at C2D15
Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C2D15
Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C2D15
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C2D15
Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At C3D1Population: SAF with available data was analyzed. No participants from Phase 2 monotherapy dose expansion entered C3D1 therefore, the number of participants is 0.
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead.
Outcome measures
| Measure |
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^7 Cells/Dose)
n=1 Participants
Participants received one dose of ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose)
n=3 Participants
Participants received one dose of ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose)
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.)
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab
n=1 Participants
Participants received ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab
n=5 Participants
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
|---|---|---|---|---|---|
|
Number of Participants With ECOG Performance Status at C3D1
Grade 0
|
0 Participants
|
1 Participants
|
—
|
1 Participants
|
1 Participants
|
|
Number of Participants With ECOG Performance Status at C3D1
Grade 1
|
1 Participants
|
2 Participants
|
—
|
0 Participants
|
4 Participants
|
|
Number of Participants With ECOG Performance Status at C3D1
Grade 2
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C3D1
Grade 3
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C3D1
Grade 4
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C3D1
Grade 5
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At C3D8Population: SAF with available data was analyzed. No participants from Phase 2 monotherapy dose expansion entered C3D8 therefore, the number of participants is 0.
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead.
Outcome measures
| Measure |
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^7 Cells/Dose)
n=1 Participants
Participants received one dose of ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose)
n=3 Participants
Participants received one dose of ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose)
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.)
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab
n=1 Participants
Participants received ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab
n=5 Participants
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
|---|---|---|---|---|---|
|
Number of Participants With ECOG Performance Status at C3D8
Grade 0
|
0 Participants
|
1 Participants
|
—
|
1 Participants
|
1 Participants
|
|
Number of Participants With ECOG Performance Status at C3D8
Grade 1
|
1 Participants
|
2 Participants
|
—
|
0 Participants
|
4 Participants
|
|
Number of Participants With ECOG Performance Status at C3D8
Grade 2
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C3D8
Grade 3
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C3D8
Grade 4
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C3D8
Grade 5
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At C3D15Population: SAF with available data was analyzed. No participants from Phase 2 monotherapy dose expansion entered C3D15 therefore, the number of participants is 0.
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead.
Outcome measures
| Measure |
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^7 Cells/Dose)
n=1 Participants
Participants received one dose of ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose)
n=2 Participants
Participants received one dose of ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose)
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.)
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab
n=1 Participants
Participants received ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab
n=5 Participants
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
|---|---|---|---|---|---|
|
Number of Participants With ECOG Performance Status at C3D15
Grade 0
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
1 Participants
|
|
Number of Participants With ECOG Performance Status at C3D15
Grade 1
|
1 Participants
|
2 Participants
|
—
|
0 Participants
|
4 Participants
|
|
Number of Participants With ECOG Performance Status at C3D15
Grade 2
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C3D15
Grade 3
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C3D15
Grade 4
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C3D15
Grade 5
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At C4D1Population: SAF with available data was analyzed. No participants from Phase 2 monotherapy dose expansion entered C4D1 therefore, the number of participants is 0.
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead.
Outcome measures
| Measure |
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^7 Cells/Dose)
n=1 Participants
Participants received one dose of ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose)
n=2 Participants
Participants received one dose of ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose)
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.)
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab
n=1 Participants
Participants received ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab
n=4 Participants
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
|---|---|---|---|---|---|
|
Number of Participants With ECOG Performance Status at C4D1
Grade 0
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
1 Participants
|
|
Number of Participants With ECOG Performance Status at C4D1
Grade 1
|
1 Participants
|
2 Participants
|
—
|
0 Participants
|
3 Participants
|
|
Number of Participants With ECOG Performance Status at C4D1
Grade 2
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C4D1
Grade 3
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C4D1
Grade 4
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C4D1
Grade 5
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At C4D8Population: SAF with available data was analyzed. No participants from Phase 2 monotherapy dose expansion entered C4D8 therefore, the number of participants is 0.
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead.
Outcome measures
| Measure |
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^7 Cells/Dose)
n=1 Participants
Participants received one dose of ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose)
n=1 Participants
Participants received one dose of ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose)
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.)
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab
n=1 Participants
Participants received ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab
n=4 Participants
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
|---|---|---|---|---|---|
|
Number of Participants With ECOG Performance Status at C4D8
Grade 0
|
0 Participants
|
0 Participants
|
—
|
1 Participants
|
1 Participants
|
|
Number of Participants With ECOG Performance Status at C4D8
Grade 1
|
1 Participants
|
0 Participants
|
—
|
0 Participants
|
3 Participants
|
|
Number of Participants With ECOG Performance Status at C4D8
Grade 2
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C4D8
Grade 3
|
0 Participants
|
1 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C4D8
Grade 4
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C4D8
Grade 5
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At C4D15Population: SAF with available data was analyzed. No participants from Phase 1 monotherapy dose escalation (with dosage ASP7517 1x10\^8 cells/dose) and Phase 2 monotherapy dose expansion entered C4D15 therefore, the number of participants is 0.
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead.
Outcome measures
| Measure |
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^7 Cells/Dose)
n=1 Participants
Participants received one dose of ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose)
Participants received one dose of ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose)
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.)
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab
n=1 Participants
Participants received ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab
n=3 Participants
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
|---|---|---|---|---|---|
|
Number of Participants With ECOG Performance Status at C4D15
Grade 5
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C4D15
Grade 3
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C4D15
Grade 4
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C4D15
Grade 0
|
0 Participants
|
—
|
—
|
1 Participants
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C4D15
Grade 1
|
1 Participants
|
—
|
—
|
0 Participants
|
3 Participants
|
|
Number of Participants With ECOG Performance Status at C4D15
Grade 2
|
0 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: At C5D1Population: SAF with available data was analyzed. No participants from Phase 1 monotherapy dose escalation, Phase 1 combination therapy dose escalation (with dosage ASP7517 1x10\^7 cells/dose) and Phase 2 monotherapy dose expansion entered C5D1 therefore, the number of participants is 0.
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead.
Outcome measures
| Measure |
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^7 Cells/Dose)
Participants received one dose of ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose)
Participants received one dose of ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose)
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.)
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab
Participants received ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab
n=3 Participants
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
|---|---|---|---|---|---|
|
Number of Participants With ECOG Performance Status at C5D1
Grade 0
|
—
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C5D1
Grade 1
|
—
|
—
|
—
|
—
|
3 Participants
|
|
Number of Participants With ECOG Performance Status at C5D1
Grade 2
|
—
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C5D1
Grade 3
|
—
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C5D1
Grade 4
|
—
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C5D1
Grade 5
|
—
|
—
|
—
|
—
|
0 Participants
|
PRIMARY outcome
Timeframe: At C5D8Population: SAF with available data was analyzed. No participants from Phase 1 monotherapy dose escalation, Phase 1 combination therapy dose escalation (with dosage ASP7517 1x10\^7 cells/dose) and Phase 2 monotherapy dose expansion entered C5D8 therefore, the number of participants is 0.
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead.
Outcome measures
| Measure |
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^7 Cells/Dose)
Participants received one dose of ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose)
Participants received one dose of ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose)
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.)
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab
Participants received ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab
n=3 Participants
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
|---|---|---|---|---|---|
|
Number of Participants With ECOG Performance Status at C5D8
Grade 0
|
—
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C5D8
Grade 1
|
—
|
—
|
—
|
—
|
3 Participants
|
|
Number of Participants With ECOG Performance Status at C5D8
Grade 2
|
—
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C5D8
Grade 3
|
—
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C5D8
Grade 4
|
—
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C5D8
Grade 5
|
—
|
—
|
—
|
—
|
0 Participants
|
PRIMARY outcome
Timeframe: At C5D15Population: SAF with available data was analyzed. No participants from Phase 1 monotherapy dose escalation, Phase 1 combination therapy dose escalation (with dosage ASP7517 1x10\^7 cells/dose) and Phase 2 monotherapy dose expansion entered C5D15 therefore, the number of participants is 0.
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead.
Outcome measures
| Measure |
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^7 Cells/Dose)
Participants received one dose of ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose)
Participants received one dose of ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose)
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.)
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab
Participants received ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab
n=3 Participants
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
|---|---|---|---|---|---|
|
Number of Participants With ECOG Performance Status at C5D15
Grade 0
|
—
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C5D15
Grade 1
|
—
|
—
|
—
|
—
|
3 Participants
|
|
Number of Participants With ECOG Performance Status at C5D15
Grade 2
|
—
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C5D15
Grade 3
|
—
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C5D15
Grade 4
|
—
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C5D15
Grade 5
|
—
|
—
|
—
|
—
|
0 Participants
|
PRIMARY outcome
Timeframe: At C6D1Population: SAF with available data was analyzed. No participants from Phase 1 monotherapy dose escalation, Phase 1 combination therapy dose escalation (with dosage ASP7517 1x10\^7 cells/dose) and Phase 2 monotherapy dose expansion entered C6D1 therefore, the number of participants is 0.
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead.
Outcome measures
| Measure |
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^7 Cells/Dose)
Participants received one dose of ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose)
Participants received one dose of ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose)
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.)
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab
Participants received ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab
n=3 Participants
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
|---|---|---|---|---|---|
|
Number of Participants With ECOG Performance Status at C6D1
Grade 0
|
—
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C6D1
Grade 1
|
—
|
—
|
—
|
—
|
3 Participants
|
|
Number of Participants With ECOG Performance Status at C6D1
Grade 2
|
—
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C6D1
Grade 3
|
—
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C6D1
Grade 4
|
—
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C6D1
Grade 5
|
—
|
—
|
—
|
—
|
0 Participants
|
PRIMARY outcome
Timeframe: At C6D8Population: SAF with available data was analyzed. No participants from Phase 1 monotherapy dose escalation, Phase 1 combination therapy dose escalation (with dosage ASP7517 1x10\^7 cells/dose) and Phase 2 monotherapy dose expansion entered C6D8 therefore, the number of participants is 0.
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead.
Outcome measures
| Measure |
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^7 Cells/Dose)
Participants received one dose of ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose)
Participants received one dose of ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose)
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.)
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab
Participants received ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab
n=2 Participants
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
|---|---|---|---|---|---|
|
Number of Participants With ECOG Performance Status at C6D8
Grade 0
|
—
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C6D8
Grade 1
|
—
|
—
|
—
|
—
|
2 Participants
|
|
Number of Participants With ECOG Performance Status at C6D8
Grade 2
|
—
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C6D8
Grade 3
|
—
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C6D8
Grade 4
|
—
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C6D8
Grade 5
|
—
|
—
|
—
|
—
|
0 Participants
|
PRIMARY outcome
Timeframe: At C6D15Population: SAF with available data was analyzed. No participants from Phase 1 monotherapy dose escalation, Phase 1 combination therapy dose escalation (with dosage ASP7517 1x10\^7 cells/dose) and Phase 2 monotherapy dose expansion entered C6D15 therefore, the number of participants is 0.
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead.
Outcome measures
| Measure |
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^7 Cells/Dose)
Participants received one dose of ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose)
Participants received one dose of ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose)
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.)
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab
Participants received ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab
n=1 Participants
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
|---|---|---|---|---|---|
|
Number of Participants With ECOG Performance Status at C6D15
Grade 0
|
—
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C6D15
Grade 1
|
—
|
—
|
—
|
—
|
1 Participants
|
|
Number of Participants With ECOG Performance Status at C6D15
Grade 2
|
—
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C6D15
Grade 3
|
—
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C6D15
Grade 4
|
—
|
—
|
—
|
—
|
0 Participants
|
|
Number of Participants With ECOG Performance Status at C6D15
Grade 5
|
—
|
—
|
—
|
—
|
0 Participants
|
PRIMARY outcome
Timeframe: At EOT (Approximately 511 [504 +7] days)Population: SAF with available data was analyzed.
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. EOT visit was conducted for all participants after 7 days of last dose.
Outcome measures
| Measure |
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^7 Cells/Dose)
n=2 Participants
Participants received one dose of ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose)
n=7 Participants
Participants received one dose of ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose)
n=2 Participants
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.)
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab
Participants received ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
|---|---|---|---|---|---|
|
Number of Participants With ECOG Performance Status at End of Treatment (EOT): Monotherapy
Grade 0
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With ECOG Performance Status at End of Treatment (EOT): Monotherapy
Grade 1
|
1 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants With ECOG Performance Status at End of Treatment (EOT): Monotherapy
Grade 2
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With ECOG Performance Status at End of Treatment (EOT): Monotherapy
Grade 3
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With ECOG Performance Status at End of Treatment (EOT): Monotherapy
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With ECOG Performance Status at End of Treatment (EOT): Monotherapy
Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: At EOT (Approximately 824 [817 +7] days)Population: SAF with available data was analyzed.
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead. EOT visit was conducted for all participants after 7 days of last dose.
Outcome measures
| Measure |
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^7 Cells/Dose)
n=1 Participants
Participants received one dose of ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose)
n=5 Participants
Participants received one dose of ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose)
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.)
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab
Participants received ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
|---|---|---|---|---|---|
|
Number of Participants With ECOG Performance Status at End of Treatment (EOT): Combination Therapy.
Grade 0
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With ECOG Performance Status at End of Treatment (EOT): Combination Therapy.
Grade 1
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
|
Number of Participants With ECOG Performance Status at End of Treatment (EOT): Combination Therapy.
Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With ECOG Performance Status at End of Treatment (EOT): Combination Therapy.
Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With ECOG Performance Status at End of Treatment (EOT): Combination Therapy.
Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With ECOG Performance Status at End of Treatment (EOT): Combination Therapy.
Grade 5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At 30 days safety Follow Up (Approximately 541 [511+30] days)Population: SAF with available data was analyzed. No participants from Phase 1 monotherapy dose escalation (with dosage ASP7517 1x10\^7 cells/dose) and Phase 2 monotherapy dose expansion entered the 30 day follow up period therefore, the number of participants is 0.
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead.
Outcome measures
| Measure |
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^7 Cells/Dose)
Participants received one dose of ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose)
n=1 Participants
Participants received one dose of ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose)
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.)
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab
Participants received ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
|---|---|---|---|---|---|
|
Number of Participants With ECOG Performance Status at 30 Day Follow Up: Monotherapy
Grade 0
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With ECOG Performance Status at 30 Day Follow Up: Monotherapy
Grade 1
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With ECOG Performance Status at 30 Day Follow Up: Monotherapy
Grade 2
|
—
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With ECOG Performance Status at 30 Day Follow Up: Monotherapy
Grade 3
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With ECOG Performance Status at 30 Day Follow Up: Monotherapy
Grade 4
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With ECOG Performance Status at 30 Day Follow Up: Monotherapy
Grade 5
|
—
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At 30 days safety Follow Up (Approximately 854 [824+30 ] days)Population: SAF with available data was analyzed.
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead.
Outcome measures
| Measure |
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^7 Cells/Dose)
n=1 Participants
Participants received one dose of ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose)
n=3 Participants
Participants received one dose of ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose)
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.)
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab
Participants received ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
|---|---|---|---|---|---|
|
Number of Participants With ECOG Performance Status at 30 Day Follow Up: Combination Therapy
Grade 0
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With ECOG Performance Status at 30 Day Follow Up: Combination Therapy
Grade 1
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With ECOG Performance Status at 30 Day Follow Up: Combination Therapy
Grade 2
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With ECOG Performance Status at 30 Day Follow Up: Combination Therapy
Grade 3
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With ECOG Performance Status at 30 Day Follow Up: Combination Therapy
Grade 4
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With ECOG Performance Status at 30 Day Follow Up: Combination Therapy
Grade 5
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At 60 days safety Follow Up (Approximately 571 [511+60] days)Population: SAF with available data was analyzed.
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead.
Outcome measures
| Measure |
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^7 Cells/Dose)
n=1 Participants
Participants received one dose of ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose)
n=1 Participants
Participants received one dose of ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose)
n=1 Participants
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.)
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab
Participants received ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
|---|---|---|---|---|---|
|
Number of Participants With ECOG Performance Status at 60 Day Follow Up: Monotherapy
Grade 0
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With ECOG Performance Status at 60 Day Follow Up: Monotherapy
Grade 1
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With ECOG Performance Status at 60 Day Follow Up: Monotherapy
Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With ECOG Performance Status at 60 Day Follow Up: Monotherapy
Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With ECOG Performance Status at 60 Day Follow Up: Monotherapy
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With ECOG Performance Status at 60 Day Follow Up: Monotherapy
Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: At 60 days safety Follow Up (Approximately 884 [824+60] days)Population: SAF with available data was analyzed. No participants from Phase 1 combination therapy dose escalation (with dosage ASP7517 1x10\^7 cells/dose) entered the 60 day follow up period therefore, the number of participants is 0.
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead.
Outcome measures
| Measure |
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^7 Cells/Dose)
Participants received one dose of ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose)
n=1 Participants
Participants received one dose of ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose)
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.)
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab
Participants received ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
|---|---|---|---|---|---|
|
Number of Participants With ECOG Performance Status at 60 Day Follow Up: Combination Therapy
Grade 0
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With ECOG Performance Status at 60 Day Follow Up: Combination Therapy
Grade 1
|
—
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With ECOG Performance Status at 60 Day Follow Up: Combination Therapy
Grade 2
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With ECOG Performance Status at 60 Day Follow Up: Combination Therapy
Grade 3
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With ECOG Performance Status at 60 Day Follow Up: Combination Therapy
Grade 4
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With ECOG Performance Status at 60 Day Follow Up: Combination Therapy
Grade 5
|
—
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At 90 days safety follow up (Approximately 601 [511+90] days)Population: SAF with available data was analyzed. No participants from the Phase 1 monotherapy therapy dose escalation (with dosage ASP7517 1x10\^7 cells/dose) and Phase 2 monotherapy dose expansion entered the 90 day follow up period therefore, the number of participants is 0.
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead.
Outcome measures
| Measure |
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^7 Cells/Dose)
Participants received one dose of ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose)
n=1 Participants
Participants received one dose of ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose)
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.)
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab
Participants received ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
|---|---|---|---|---|---|
|
Number of Participants With ECOG Performance Status at 90 Day Follow Up: Monotherapy
Grade 0
|
—
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With ECOG Performance Status at 90 Day Follow Up: Monotherapy
Grade 1
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With ECOG Performance Status at 90 Day Follow Up: Monotherapy
Grade 2
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With ECOG Performance Status at 90 Day Follow Up: Monotherapy
Grade 3
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With ECOG Performance Status at 90 Day Follow Up: Monotherapy
Grade 4
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With ECOG Performance Status at 90 Day Follow Up: Monotherapy
Grade 5
|
—
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: At 90 days safety follow up (Approximately 914 [824+90] days)Population: SAF with available data was analyzed. No participants from the Phase 1 combination therapy dose escalation (with dosage ASP7517 1x10\^7 cells/dose) entered the 90 day follow up period therefore, the number of participants is 0.
The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1 - Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2 - Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3 - Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4 - Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5 -Dead.
Outcome measures
| Measure |
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^7 Cells/Dose)
Participants received one dose of ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose)
n=1 Participants
Participants received one dose of ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose)
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.)
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab
Participants received ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
|---|---|---|---|---|---|
|
Number of Participants With ECOG Performance Status at 90 Day Follow Up: Combination Therapy
Grade 0
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With ECOG Performance Status at 90 Day Follow Up: Combination Therapy
Grade 1
|
—
|
1 Participants
|
—
|
—
|
—
|
|
Number of Participants With ECOG Performance Status at 90 Day Follow Up: Combination Therapy
Grade 2
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With ECOG Performance Status at 90 Day Follow Up: Combination Therapy
Grade 3
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With ECOG Performance Status at 90 Day Follow Up: Combination Therapy
Grade 4
|
—
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With ECOG Performance Status at 90 Day Follow Up: Combination Therapy
Grade 5
|
—
|
0 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From C1D1 up to C1D28Population: The DLT evaluation analysis set (DEAS) consisted of all participants in SAF excluding participants who met any of the following criteria: * Participant was discovered to have enrolled without fully satisfying eligibility criteria. * Participant received less than the planned dose in cycle 1 for reasons other than DLT. * Participant had no DLT and withdraws from the study before the end of DLT evaluation period. DLTs were analyzed only in Phase 1 .
DLT: any event occurring within 28 days of first dose on C1D1 and graded as: \*Non-hematologic AEs \>= grade 3 and not resolving to \<= grade 2 within 72 hours. \*Confirmed Hy's law case. \*Infusion-related reactions requiring infusion discontinuation, prolonged delay (\> 2 weeks) in initiating C2 due to treatment-related toxicity. \*Any treatment-related toxicity causing discontinuation in C1. \*Grade \>= 3 thrombocytopenia/bleeding requiring transfusion/hospitalization, grade \>= 3 anemia requiring transfusion, grade 3 febrile neutropenia with/without infection and grade 5 treatment-related toxicity, grade \>= 2 pneumonitis, grade \>= 2 encephalopathy, meningitis or motor/sensory neuropathy. \*Aspartate aminotransferase (AST) / alanine aminotransferase (ALT) \> 5 × upper limit of normal (ULN) in participants without liver metastases, AST/ALT \> 8×ULN in participants with liver metastases, total bilirubin \> 3×ULN (grade \>= 3). \*Guillain-Barré syndrome/myasthenic syndrome/myasthenia gravis.
Outcome measures
| Measure |
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^7 Cells/Dose)
n=3 Participants
Participants received one dose of ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose)
n=8 Participants
Participants received one dose of ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose)
n=2 Participants
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.)
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab
n=8 Participants
Participants received ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: From first dose up to 954 daysPopulation: Response analysis set (RAS) consisted of all participants who were enrolled and received at least 1 dose of investigational product (IP) and had at least 1 postbaseline primary efficacy measurement.
iORR was defined as the percentage of participants for each dose level whose best overall response was rated as confirmed iCR or iPR per iRECIST by independent central review. iCR was complete response based on iRECIST and defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be \<10 millimeter (mm) in the short axis. iPR was partial response based on iRECIST was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. iORR assessments included: * iORR with confirmed response by investigator assessment * iORR with unconfirmed response by investigator assessment For confirmed response for iCR/iPR, scan had to be done 4 weeks after iPR/iCR was first observed. Participants who had iCR/iPR were considered as having confirmed response and those that did not fulfil this criteria were considered as having unconfirmed response.
Outcome measures
| Measure |
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^7 Cells/Dose)
n=3 Participants
Participants received one dose of ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose)
n=7 Participants
Participants received one dose of ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose)
n=2 Participants
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.)
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab
n=3 Participants
Participants received ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab
n=7 Participants
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
|---|---|---|---|---|---|
|
Objective Response Rate (iORR) Per Immune Response Evaluation Criteria in Solid Tumors (iRECIST) by Investigator Assessment
iORR with confirmation
|
0 Percentage of Participants
Interval 0.0 to 70.8
|
0 Percentage of Participants
Interval 0.0 to 41.0
|
0 Percentage of Participants
Interval 0.0 to 84.2
|
0 Percentage of Participants
Interval 0.0 to 70.8
|
0 Percentage of Participants
Interval 0.0 to 41.0
|
|
Objective Response Rate (iORR) Per Immune Response Evaluation Criteria in Solid Tumors (iRECIST) by Investigator Assessment
iORR without confirmation
|
0 Percentage of Participants
Interval 0.0 to 70.8
|
0 Percentage of Participants
Interval 0.0 to 41.0
|
0 Percentage of Participants
Interval 0.0 to 84.2
|
0 Percentage of Participants
Interval 0.0 to 70.8
|
0 Percentage of Participants
Interval 0.0 to 41.0
|
SECONDARY outcome
Timeframe: From first dose up to 954 daysPopulation: RAS
ORR was defined as the percentage of participants for each dose level whose best overall response is rated as complete response (CR) or partial response (PR) per RECIST v1.1. CR was complete response based on RECIST and defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be \<10 mm in the short axis. PR was partial response based on RECIST and defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. ORR assessment included: * ORR with confirmed response by investigator assessment * ORR with unconfirmed response by investigator assessment For confirmed response for CR/PR, scan had to be done 4 weeks after PR/CR was first observed. Participants who had CR/PR were considered as having confirmed response and those that did not fulfil this criteria were considered as having unconfirmed response.
Outcome measures
| Measure |
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^7 Cells/Dose)
n=3 Participants
Participants received one dose of ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose)
n=7 Participants
Participants received one dose of ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose)
n=2 Participants
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.)
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab
n=3 Participants
Participants received ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab
n=7 Participants
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
|---|---|---|---|---|---|
|
Objective Response Rate (ORR) Per RECIST v1.1 by Investigator Assessment
ORR with confirmation
|
0 Percentage of Participants
Interval 0.0 to 70.8
|
0 Percentage of Participants
Interval 0.0 to 41.0
|
0 Percentage of Participants
Interval 0.0 to 84.2
|
0 Percentage of Participants
Interval 0.0 to 70.8
|
0 Percentage of Participants
Interval 0.0 to 41.0
|
|
Objective Response Rate (ORR) Per RECIST v1.1 by Investigator Assessment
ORR without confirmation
|
0 Percentage of Participants
Interval 0.0 to 70.8
|
0 Percentage of Participants
Interval 0.0 to 41.0
|
0 Percentage of Participants
Interval 0.0 to 84.2
|
0 Percentage of Participants
Interval 0.0 to 70.8
|
0 Percentage of Participants
Interval 0.0 to 41.0
|
SECONDARY outcome
Timeframe: From first dose up to 954 daysPopulation: RAS
iDCR: Percentage of participants for each dose level whose best overall response is rated as confirmed iCR, iPR or iSD per iRECIST. iCR: Complete response based on iRECIST, defined as disappearance of all target/non target lesions and pathological lymph nodes must be \<10 millimeter (mm) in the short axis. iPR: Partial response based on iRECIST, defined as at least 30% decrease in the sum of diameters of target lesions, with reference to the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for iPR nor sufficient increase to qualify for PD. PD: Defined as at least 20% increase in the sum of diameters of target lesions, with reference to the smallest sum of diameters recorded since the treatment started. For confirmed response for iCR/iPR, scan had to be done 4 weeks after iPR/iCR was first observed. Participants who had iCR/iPR were considered as having confirmed response and those that did not fulfil this criteria were considered as having unconfirmed response.
Outcome measures
| Measure |
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^7 Cells/Dose)
n=3 Participants
Participants received one dose of ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose)
n=7 Participants
Participants received one dose of ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose)
n=2 Participants
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.)
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab
n=3 Participants
Participants received ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab
n=7 Participants
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
|---|---|---|---|---|---|
|
Disease Control Rate Per iRECIST (iDCR) by Investigator Assessment
iDCR with confirmation
|
33.3 Percentage of Participants
Interval 0.8 to 90.6
|
42.9 Percentage of Participants
Interval 9.9 to 81.6
|
0 Percentage of Participants
Interval 0.0 to 84.2
|
33.3 Percentage of Participants
Interval 0.8 to 90.6
|
57.1 Percentage of Participants
Interval 18.4 to 90.1
|
|
Disease Control Rate Per iRECIST (iDCR) by Investigator Assessment
iDCR without confirmation
|
33.3 Percentage of Participants
Interval 0.8 to 90.6
|
42.9 Percentage of Participants
Interval 9.9 to 81.6
|
0 Percentage of Participants
Interval 0.0 to 84.2
|
33.3 Percentage of Participants
Interval 0.8 to 90.6
|
57.1 Percentage of Participants
Interval 18.4 to 90.1
|
SECONDARY outcome
Timeframe: From first dose up to 954 daysPopulation: RAS
DCR: Percentage of participants for each dose level whose best overall response is rated as confirmed CR, PR or SD per RECIST v1.1. CR: Complete response based on RECIST and defined as disappearance of all target/non target lesions and any pathological lymph nodes must be \<10 mm in the short axis. PR: Partial response based on RECIST and defined as at least a 30% decrease in the sum of diameters of target lesions, with reference to, the baseline sum of diameters. SD: Neither sufficient shrinkage to qualify for iPR nor sufficient increase to qualify for PD. PD: At least a 20% increase in the sum of diameters of target lesions, with reference to, the smallest sum of diameters recorded since treatment started. For confirmed response for CR/PR, scan had to be done 4 weeks after PR/CR was first observed. Participants who had CR/PR were considered as having confirmed response and those that did not fulfil this criteria were considered as having unconfirmed response.
Outcome measures
| Measure |
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^7 Cells/Dose)
n=3 Participants
Participants received one dose of ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose)
n=7 Participants
Participants received one dose of ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose)
n=2 Participants
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.)
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab
n=3 Participants
Participants received ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab
n=7 Participants
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
|---|---|---|---|---|---|
|
Disease Control Rate (DCR) Per RECIST v1.1 by Investigator Assessment
DCR with confirmation
|
33.3 Percentage of Participants
Interval 0.8 to 90.6
|
42.9 Percentage of Participants
Interval 9.9 to 81.6
|
0 Percentage of Participants
Interval 0.0 to 84.2
|
33.3 Percentage of Participants
Interval 0.8 to 90.6
|
57.1 Percentage of Participants
Interval 18.4 to 90.1
|
|
Disease Control Rate (DCR) Per RECIST v1.1 by Investigator Assessment
DCR without confirmation
|
33.3 Percentage of Participants
Interval 0.8 to 90.6
|
42.9 Percentage of Participants
Interval 9.9 to 81.6
|
0 Percentage of Participants
Interval 0.0 to 84.2
|
33.3 Percentage of Participants
Interval 0.8 to 90.6
|
57.1 Percentage of Participants
Interval 18.4 to 90.1
|
SECONDARY outcome
Timeframe: From first dose until death from any cause or radiographic disease progression (up to 954 days)Population: Full analysis set (FAS) consisted of all participants who were enrolled and received at least 1 dose of study drug.
iPFS was defined as the time from the start of the study treatment until death from any cause or radiographic disease progression assessed per iRECIST by independent central review and investigator assessment, whichever occurs first. Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started. Kaplan Meier estimate was used for analysis of time-to-event endpoints.
Outcome measures
| Measure |
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^7 Cells/Dose)
n=3 Participants
Participants received one dose of ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose)
n=8 Participants
Participants received one dose of ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose)
n=2 Participants
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.)
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab
n=3 Participants
Participants received ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab
n=8 Participants
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
|---|---|---|---|---|---|
|
Progression-Free Survival Per iRECIST (iPFS) Using Investigator Assessment
|
398.0 days
Interval 57.0 to 404.0
|
57.0 days
Interval 32.0 to 112.0
|
77.0 days
Due to low number of events, lower and upper limit of CI was not estimable.
|
106.0 days
Interval 54.0 to 142.0
|
106.0 days
Interval 37.0 to 164.0
|
SECONDARY outcome
Timeframe: From first dose until death from any cause or radiographic disease progression (up to 954 days)Population: FAS
PFS was defined as the time from the start of the study treatment until death from any cause or radiographic disease progression assessed per RECIST by independent central review and investigator assessment, whichever occurred first. Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started. Kaplan Meier estimate was used for analysis of time-to-event endpoints.
Outcome measures
| Measure |
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^7 Cells/Dose)
n=3 Participants
Participants received one dose of ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose)
n=8 Participants
Participants received one dose of ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose)
n=2 Participants
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.)
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab
n=3 Participants
Participants received ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab
n=8 Participants
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
|---|---|---|---|---|---|
|
Progression-Free Survival Per RECIST (PFS) Using Investigator Assessment
|
57.0 days
Interval 29.0 to 99.0
|
57.0 days
Interval 32.0 to 112.0
|
77.0 days
Due to low number of events, lower and upper limit of CI was not estimable.
|
57.0 days
Interval 29.0 to 99.0
|
57.0 days
Interval 32.0 to 112.0
|
SECONDARY outcome
Timeframe: From first dose until death from any cause (up to 954 days)Population: FAS
OS was defined as the time from the date of first dose until the date of death from any cause (death date - first dose date + 1). For a participant who is not known to have died by the end of study follow-up, OS is censored at the date of last contact (date of last contact - first dose date + 1). Kaplan Meier estimate was used for analysis of time-to-event endpoints.
Outcome measures
| Measure |
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^7 Cells/Dose)
n=3 Participants
Participants received one dose of ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose)
n=8 Participants
Participants received one dose of ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose)
n=2 Participants
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.)
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab
n=3 Participants
Participants received ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8cells/Dose) and Pembrolizumab
n=8 Participants
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
|---|---|---|---|---|---|
|
Overall Survival (OS)
|
404.0 days
Interval 398.0 to
Due to low number of events, upper limit of CI was not estimable.
|
169.0 days
Interval 57.0 to 297.0
|
NA days
Interval 77.0 to
Due to low number of events, median and upper limit of CI was not estimable.
|
NA days
Interval 142.0 to
Due to low number of events, median and upper limit of CI was not estimable.
|
NA days
Interval 200.0 to
Due to low number of events, median and upper limit of CI was not estimable.
|
SECONDARY outcome
Timeframe: From first response up to the date of radiographical progression (up to 954 days)Population: No participant had a response of iCR or iPR and therefore iDOR was not evaluable.
iDOR was defined as the time from the date of the first response iCR/iPR (whichever was first recorded) to the date of radiographical progression or date of censoring. iCR was complete response based on iRECIST and defined as disappearance of all target and non target lesions and any pathological lymph nodes must be \<10 millimeter (mm) in the short axis. iPR was partial response based on iRECIST was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From first response up to the date of radiographical progression (up to 954 days)Population: No participant had a response of CR or PR and therefore DOR was not evaluable.
DOR is defined as the time from the date of the first response CR/PR (whichever is first recorded) to the date of radiographical progression or date of censoring. DOR will be calculated only for the subgroup of participants with confirmed response CR/PR per RECIST v1.1, separately for independent central review and for investigator assessment. CR was complete response based on RECIST and defined as disappearance of all target and non target lesions and any pathological lymph nodes must be \<10 mm in the short axis. PR was partial response based on RECIST and defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started.
Outcome measures
Outcome data not reported
Adverse Events
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^7 Cells/Dose)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose)
Serious events: 2 serious events
Other events: 7 other events
Deaths: 3 deaths
Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 1 deaths
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8 Cells/Dose) and Pembrolizumab
Serious events: 2 serious events
Other events: 8 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^7 Cells/Dose)
n=3 participants at risk
Participants received one dose of ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose)
n=8 participants at risk
Participants received one dose of ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose)
n=2 participants at risk
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.)
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab
n=3 participants at risk
Participants received ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8 Cells/Dose) and Pembrolizumab
n=8 participants at risk
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
Other adverse events
| Measure |
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^7 Cells/Dose)
n=3 participants at risk
Participants received one dose of ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Monotherapy Dose Escalation (ASP7517 1x10^8 Cells/Dose)
n=8 participants at risk
Participants received one dose of ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days). Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.
|
Phase 2: Monotherapy Dose Expansion (ASP7517 1x10^8 Cells/Dose)
n=2 participants at risk
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) by IV infusion (4 to 6 mL/minute) on Day 1 of each cycle (1 Cycle=28 days).Following the first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (defined as radiological response or SD, or reduction of disease-related symptoms) continued further treatment with ASP7517, as decided by the investigator. After completing 4 cycles of treatment, any participants who achieved confirmed CR did not continue with ASP7517, and any participants who achieved PR or SD received an additional 2 doses. Participants entered an Observation Period except those with iCPD, iUPD (per independent central review or local review) and who were not clinically stable or clinical progression was confirmed by the investigator and were followed for up to 48 weeks until iCPD per independent central review, initiation of a new anticancer therapy or meeting 1 of the Observation Period discontinuation criteria, whichever occurred first. After the EOT visit, participants completed the Safety follow-up visits 30, 60 and 90 days.)
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^7 Cells/Dose) and Pembrolizumab
n=3 participants at risk
Participants received ASP7517 1x10\^7 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
Phase 1: Combination Therapy Dose Escalation (ASP7517 1x10^8 Cells/Dose) and Pembrolizumab
n=8 participants at risk
Participants received ASP7517 1x10\^8 cells/dose for up to 6 doses (168 days) on Day 1 of each cycle by IV infusion (4 to 6 mL/minute) (1 Cycle=28 days) in combination with 400mg pembrolizumab infusion (over 30 minutes) with up to 4 doses every 6 weeks. Following first 2 cycles, participants who had not met any individual treatment discontinuation criteria and were receiving clinical benefit (radiological response or SD/reduction of disease-related symptoms) continued further treatment with ASP7517 and pembrolizumab as decided by investigator. Participants who achieved confirmed CR within first 4 cycles could not receive further treatment with ASP7517 at cycle 5 and 6; and participants who achieved PR or SD after 4 doses could receive additional 2 doses of ASP7517 in combination with pembrolizumab. Subsequent to Treatment Period, all participants, except those with iCPD, iUPD who were not clinically stable or had clinical disease progression per independent central review or local review, entered Observation Period were allowed to continue to receive pembrolizumab alone up to total of 17 doses of pembrolizumab to monitor treatment response and were followed for up to 96 weeks until iCPD (confirmed by independent central review or local review), initiation of new anticancer therapy or meeting 1 of Observation Period discontinuation criteria, whichever occurred first. After EOT visit, participants completed Safety follow-up visits 30, 60 and 90 days.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
33.3%
1/3 • Number of events 2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
50.0%
1/2 • Number of events 3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Cardiac disorders
Nodal rhythm
|
33.3%
1/3 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Eye disorders
Eye pain
|
33.3%
1/3 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
25.0%
2/8 • Number of events 2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
25.0%
2/8 • Number of events 2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
25.0%
2/8 • Number of events 2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
25.0%
2/8 • Number of events 4 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
General disorders
Catheter site rash
|
33.3%
1/3 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
General disorders
Chills
|
66.7%
2/3 • Number of events 2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
37.5%
3/8 • Number of events 6 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
100.0%
2/2 • Number of events 2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
66.7%
2/3 • Number of events 2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
50.0%
4/8 • Number of events 5 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
General disorders
Influenza like illness
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
37.5%
3/8 • Number of events 7 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
25.0%
2/8 • Number of events 3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 7 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
25.0%
2/8 • Number of events 2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
50.0%
1/2 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
25.0%
2/8 • Number of events 2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
50.0%
1/2 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
66.7%
2/3 • Number of events 2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
25.0%
2/8 • Number of events 5 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
33.3%
1/3 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
33.3%
1/3 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
50.0%
1/2 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to skin
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
37.5%
3/8 • Number of events 6 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Vaginal ulceration
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
33.3%
1/3 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
50.0%
1/2 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
33.3%
1/3 • Number of events 2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
33.3%
1/3 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
33.3%
1/3 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
25.0%
2/8 • Number of events 2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/8 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/2 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
0.00%
0/3 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
12.5%
1/8 • Number of events 1 • Time frame for adverse events: From first dose up to 30 days after last dose (approximately 534 days for monotherapy and approximately 847 days for combination therapy). Time frame for all-cause mortality: From randomization up to end of study (approximately 954 days)
All-cause mortality: All randomized participants. Adverse events: SAF consisted of all participants who took at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
- Publication restrictions are in place
Restriction type: OTHER