Trial Outcomes & Findings for Boost GVAX Pancreas Vaccine With or Without CY in Patients With Pancreas Cancer (NCT NCT01088789)
NCT ID: NCT01088789
Last Updated: 2025-08-26
Results Overview
Safety as measured by local and systemic toxicity according to NCI CTCAE v 3.0
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
71 participants
Primary outcome timeframe
121 Months
Results posted on
2025-08-26
Participant Flow
Participant milestones
| Measure |
Cohort 1 (J0810 Arm A)
Patients coming from J0810 (NCT00727441) Patients receive GVAX
GVAX Pancreas Vaccine: Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
|
Cohort 1 (J0810 Arm B)
Patients coming from J0810 (NCT00727441) Patients receive IV CY and GVAX
Cyclophosphamide (CY): Cohort 1 (J0810 Arm B), Cohort 3, Cohort 4, and Cohort 5 patients will receive 200mg/m\^2 CY administered IV on day 0 of each Cycle (every 6 months). Cohort 2 patients will receive 200mg/m\^2 CY administered IV on Day 0 of the first 3 cycles (every 28 days) and Day 0 of subsequent Cycles (every 6 months).
GVAX Pancreas Vaccine: Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
|
Cohort 1 (J0810 Arm C)
Patients coming from J0810 (NCT00727441) Patients receive oral CY and GVAX
Cyclophosphamide Pill: Cohort 1 patients (J0810 Arm C) will receive 50mg oral CY once a day starting 28 days prior to GVAX and for 28 days post-GVAX (every 6 months).
GVAX Pancreas Vaccine: Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
|
Cohort 2 (Vaccine Naive)
Patients receive IV CY and GVAX
Cyclophosphamide: Cohort 1 (J0810 Arm B), Cohort 3, Cohort 4, and Cohort 5 patients will receive 200mg/m\^2 CY administered IV on day 0 of each Cycle (every 6 months). Cohort 2 patients will receive 200mg/m\^2 CY administered IV on Day 0 of the first 3 cycles (every 28 days) and Day 0 of subsequent Cycles (every 6 months).
GVAX Pancreas Vaccine: Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
|
Cohort 3 (J1568)
Patients coming from J1568 (NCT02451982) Patients receive IV CY and GVAX
Cyclophosphamide: Cohort 1 (J0810 Arm B), Cohort 3, Cohort 4, and Cohort 5 patients will receive 200mg/m\^2 CY administered IV on day 0 of each Cycle (every 6 months). Cohort 2 patients will receive 200mg/m\^2 CY administered IV on Day 0 of the first 3 cycles (every 28 days) and Day 0 of subsequent Cycles (every 6 months).
GVAX Pancreas Vaccine: Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
|
Cohort 4 (J15237)
Patients coming from J15237 (NCT02648282) Patients receive IV CY and GVAX
Cyclophosphamide: Cohort 1 (J0810 Arm B), Cohort 3, Cohort 4, and Cohort 5 patients will receive 200mg/m\^2 CY administered IV on day 0 of each Cycle (every 6 months). Cohort 2 patients will receive 200mg/m\^2 CY administered IV on Day 0 of the first 3 cycles (every 28 days) and Day 0 of subsequent Cycles (every 6 months).
GVAX Pancreas Vaccine: Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
|
Cohort 5 (J1766)
Patients coming from J1766 (NCT03153410) Patients receive IV CY and GVAX
Cyclophosphamide: Cohort 1 (J0810 Arm B), Cohort 3, Cohort 4, and Cohort 5 patients will receive 200mg/m\^2 CY administered IV on day 0 of each Cycle (every 6 months). Cohort 2 patients will receive 200mg/m\^2 CY administered IV on Day 0 of the first 3 cycles (every 28 days) and Day 0 of subsequent Cycles (every 6 months).
GVAX Pancreas Vaccine: Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
3
|
2
|
52
|
6
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
3
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
8
|
3
|
2
|
49
|
6
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Boost GVAX Pancreas Vaccine With or Without CY in Patients With Pancreas Cancer
Baseline characteristics by cohort
| Measure |
Cohort 1 (J0810 Arm A)
n=8 Participants
Patients coming from J0810 (NCT00727441) Patients receive GVAX
GVAX Pancreas Vaccine: Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
|
Cohort 1 (J0810 Arm B)
n=3 Participants
Patients coming from J0810 (NCT00727441) Patients receive IV CY and GVAX
Cyclophosphamide: Cohort 1 (J0810 Arm B), Cohort 3, Cohort 4, and Cohort 5 patients will receive 200mg/m\^2 CY administered IV on day 0 of each Cycle (every 6 months). Cohort 2 patients will receive 200mg/m\^2 CY administered IV on Day 0 of the first 3 cycles (every 28 days) and Day 0 of subsequent Cycles (every 6 months).
GVAX Pancreas Vaccine: Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
|
Cohort 1 (J0810 Arm C)
n=2 Participants
Patients coming from J0810 (NCT00727441) Patients receive oral CY and GVAX
Cyclophosphamide Pill: Cohort 1 patients (J0810 Arm C) will receive 50mg oral CY once a day starting 28 days prior to GVAX and for 28 days post-GVAX (every 6 months).
GVAX Pancreas Vaccine: Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
|
Cohort 2 (Vaccine Naive)
n=52 Participants
Patients receive IV CY and GVAX
Cyclophosphamide: Cohort 1 (J0810 Arm B), Cohort 3, Cohort 4, and Cohort 5 patients will receive 200mg/m\^2 CY administered IV on day 0 of each Cycle (every 6 months). Cohort 2 patients will receive 200mg/m\^2 CY administered IV on Day 0 of the first 3 cycles (every 28 days) and Day 0 of subsequent Cycles (every 6 months).
GVAX Pancreas Vaccine: Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
|
Cohort 3 (J1568)
n=6 Participants
Patients coming from J1568 (NCT02451982) Patients receive IV CY and GVAX
Cyclophosphamide: Cohort 1 (J0810 Arm B), Cohort 3, Cohort 4, and Cohort 5 patients will receive 200mg/m\^2 CY administered IV on day 0 of each Cycle (every 6 months). Cohort 2 patients will receive 200mg/m\^2 CY administered IV on Day 0 of the first 3 cycles (every 28 days) and Day 0 of subsequent Cycles (every 6 months).
GVAX Pancreas Vaccine: Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
|
Cohort 4 (J15237)
Patients coming from J15237 (NCT02648282) Patients receive IV CY and GVAX
Cyclophosphamide: Cohort 1 (J0810 Arm B), Cohort 3, Cohort 4, and Cohort 5 patients will receive 200mg/m\^2 CY administered IV on day 0 of each Cycle (every 6 months). Cohort 2 patients will receive 200mg/m\^2 CY administered IV on Day 0 of the first 3 cycles (every 28 days) and Day 0 of subsequent Cycles (every 6 months).
GVAX Pancreas Vaccine: Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
|
Cohort 5 (J1766)
Patients coming from J1766 (NCT03153410) Patients receive IV CY and GVAX
Cyclophosphamide: Cohort 1 (J0810 Arm B), Cohort 3, Cohort 4, and Cohort 5 patients will receive 200mg/m\^2 CY administered IV on day 0 of each Cycle (every 6 months). Cohort 2 patients will receive 200mg/m\^2 CY administered IV on Day 0 of the first 3 cycles (every 28 days) and Day 0 of subsequent Cycles (every 6 months).
GVAX Pancreas Vaccine: Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
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
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
45 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
26 Participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
34 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
37 Participants
n=24 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
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
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
|
0 Participants
n=115 Participants
|
0 Participants
n=24 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
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
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
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
70 Participants
n=24 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
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 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
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: 121 MonthsPopulation: No patients were enrolled into Cohort 4 or Cohort 5
Safety as measured by local and systemic toxicity according to NCI CTCAE v 3.0
Outcome measures
| Measure |
Cohort 1 (J0810 Arm A)
n=8 Participants
Patients coming from J0810 (NCT00727441) Patients receive GVAX
GVAX Pancreas Vaccine: Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
|
Cohort 1 (J0810 Arm B)
n=3 Participants
Patients coming from J0810 (NCT00727441) Patients receive IV CY and GVAX
Cyclophosphamide: Cohort 1 (J0810 Arm B), Cohort 3, Cohort 4, and Cohort 5 patients will receive 200mg/m\^2 CY administered IV on day 0 of each Cycle (every 6 months). Cohort 2 patients will receive 200mg/m\^2 CY administered IV on Day 0 of the first 3 cycles (every 28 days) and Day 0 of subsequent Cycles (every 6 months).
GVAX Pancreas Vaccine: Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
|
Cohort 1 (J0810 Arm C)
n=2 Participants
Patients coming from J0810 (NCT00727441) Patients receive oral CY and GVAX
Cyclophosphamide Pill: Cohort 1 patients (J0810 Arm C) will receive 50mg oral CY once a day starting 28 days prior to GVAX and for 28 days post-GVAX (every 6 months).
GVAX Pancreas Vaccine: Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
|
Cohort 2 (Vaccine Naive)
n=52 Participants
Patients receive IV CY and GVAX
Cyclophosphamide: Cohort 1 (J0810 Arm B), Cohort 3, Cohort 4, and Cohort 5 patients will receive 200mg/m\^2 CY administered IV on day 0 of each Cycle (every 6 months). Cohort 2 patients will receive 200mg/m\^2 CY administered IV on Day 0 of the first 3 cycles (every 28 days) and Day 0 of subsequent Cycles (every 6 months).
GVAX Pancreas Vaccine: Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
|
Cohort 3 (J1568)
n=6 Participants
Patients coming from J1568 (NCT02451982) Patients receive IV CY and GVAX
Cyclophosphamide: Cohort 1 (J0810 Arm B), Cohort 3, Cohort 4, and Cohort 5 patients will receive 200mg/m\^2 CY administered IV on day 0 of each Cycle (every 6 months). Cohort 2 patients will receive 200mg/m\^2 CY administered IV on Day 0 of the first 3 cycles (every 28 days) and Day 0 of subsequent Cycles (every 6 months).
GVAX Pancreas Vaccine: Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
|
Cohort 4 (J15237)
Patients coming from J15237 (NCT02648282) Patients receive IV CY and GVAX
Cyclophosphamide: Cohort 1 (J0810 Arm B), Cohort 3, Cohort 4, and Cohort 5 patients will receive 200mg/m\^2 CY administered IV on day 0 of each Cycle (every 6 months). Cohort 2 patients will receive 200mg/m\^2 CY administered IV on Day 0 of the first 3 cycles (every 28 days) and Day 0 of subsequent Cycles (every 6 months).
GVAX Pancreas Vaccine: Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
|
Cohort 5 (J1766)
Patients coming from J1766 (NCT03153410) Patients receive IV CY and GVAX
Cyclophosphamide: Cohort 1 (J0810 Arm B), Cohort 3, Cohort 4, and Cohort 5 patients will receive 200mg/m\^2 CY administered IV on day 0 of each Cycle (every 6 months). Cohort 2 patients will receive 200mg/m\^2 CY administered IV on Day 0 of the first 3 cycles (every 28 days) and Day 0 of subsequent Cycles (every 6 months).
GVAX Pancreas Vaccine: Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Experiencing Drug-Related Adverse Events (AEs) Requiring Treatment Discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 121 monthsPopulation: No patients were enrolled into Cohort 4 or Cohort 5
Safety as measured by local and systemic toxicity according to NCI CTCAE v 3.0
Outcome measures
| Measure |
Cohort 1 (J0810 Arm A)
n=8 Participants
Patients coming from J0810 (NCT00727441) Patients receive GVAX
GVAX Pancreas Vaccine: Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
|
Cohort 1 (J0810 Arm B)
n=3 Participants
Patients coming from J0810 (NCT00727441) Patients receive IV CY and GVAX
Cyclophosphamide: Cohort 1 (J0810 Arm B), Cohort 3, Cohort 4, and Cohort 5 patients will receive 200mg/m\^2 CY administered IV on day 0 of each Cycle (every 6 months). Cohort 2 patients will receive 200mg/m\^2 CY administered IV on Day 0 of the first 3 cycles (every 28 days) and Day 0 of subsequent Cycles (every 6 months).
GVAX Pancreas Vaccine: Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
|
Cohort 1 (J0810 Arm C)
n=2 Participants
Patients coming from J0810 (NCT00727441) Patients receive oral CY and GVAX
Cyclophosphamide Pill: Cohort 1 patients (J0810 Arm C) will receive 50mg oral CY once a day starting 28 days prior to GVAX and for 28 days post-GVAX (every 6 months).
GVAX Pancreas Vaccine: Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
|
Cohort 2 (Vaccine Naive)
n=52 Participants
Patients receive IV CY and GVAX
Cyclophosphamide: Cohort 1 (J0810 Arm B), Cohort 3, Cohort 4, and Cohort 5 patients will receive 200mg/m\^2 CY administered IV on day 0 of each Cycle (every 6 months). Cohort 2 patients will receive 200mg/m\^2 CY administered IV on Day 0 of the first 3 cycles (every 28 days) and Day 0 of subsequent Cycles (every 6 months).
GVAX Pancreas Vaccine: Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
|
Cohort 3 (J1568)
n=6 Participants
Patients coming from J1568 (NCT02451982) Patients receive IV CY and GVAX
Cyclophosphamide: Cohort 1 (J0810 Arm B), Cohort 3, Cohort 4, and Cohort 5 patients will receive 200mg/m\^2 CY administered IV on day 0 of each Cycle (every 6 months). Cohort 2 patients will receive 200mg/m\^2 CY administered IV on Day 0 of the first 3 cycles (every 28 days) and Day 0 of subsequent Cycles (every 6 months).
GVAX Pancreas Vaccine: Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
|
Cohort 4 (J15237)
Patients coming from J15237 (NCT02648282) Patients receive IV CY and GVAX
Cyclophosphamide: Cohort 1 (J0810 Arm B), Cohort 3, Cohort 4, and Cohort 5 patients will receive 200mg/m\^2 CY administered IV on day 0 of each Cycle (every 6 months). Cohort 2 patients will receive 200mg/m\^2 CY administered IV on Day 0 of the first 3 cycles (every 28 days) and Day 0 of subsequent Cycles (every 6 months).
GVAX Pancreas Vaccine: Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
|
Cohort 5 (J1766)
Patients coming from J1766 (NCT03153410) Patients receive IV CY and GVAX
Cyclophosphamide: Cohort 1 (J0810 Arm B), Cohort 3, Cohort 4, and Cohort 5 patients will receive 200mg/m\^2 CY administered IV on day 0 of each Cycle (every 6 months). Cohort 2 patients will receive 200mg/m\^2 CY administered IV on Day 0 of the first 3 cycles (every 28 days) and Day 0 of subsequent Cycles (every 6 months).
GVAX Pancreas Vaccine: Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Experiencing Grade 3 or Above Drug-Related Adverse Events (AEs)
|
1 Participants
|
0 Participants
|
0 Participants
|
7 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 131 monthsDFS was measured as the time from date of surgery until pancreatic cancer recurrence or death. Disease status was monitored by radiologic scans done per standard of care. DFS was censored on the date of last radiologic scan for subjects without documentation of cancer recurrence or death at the time of analysis. Estimation based on the Kaplan-Meier curve.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 174 MonthsOS was measured as the amount of time from date of surgery until death or end of follow-up. OS was censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis. Estimation based on the Kaplan-Meier curve.
Outcome measures
Outcome data not reported
Adverse Events
Cohort 1 (J0810 Arm A)
Serious events: 1 serious events
Other events: 7 other events
Deaths: 6 deaths
Cohort 1 (J0810 Arm B)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 3 deaths
Cohort 1 (J0810 Arm C)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 1 deaths
Cohort 2 (Vaccine Naive)
Serious events: 8 serious events
Other events: 52 other events
Deaths: 37 deaths
Cohort 3 (J1568)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 3 deaths
Cohort 4 (J15237)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 5 (J1766)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 (J0810 Arm A)
n=8 participants at risk
Patients coming from J0810 (NCT00727441) Patients receive GVAX
GVAX Pancreas Vaccine: Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
|
Cohort 1 (J0810 Arm B)
n=3 participants at risk
Patients coming from J0810 (NCT00727441) Patients receive IV CY and GVAX
Cyclophosphamide: Cohort 1 (J0810 Arm B), Cohort 3, Cohort 4, and Cohort 5 patients will receive 200mg/m\^2 CY administered IV on day 0 of each Cycle (every 6 months). Cohort 2 patients will receive 200mg/m\^2 CY administered IV on Day 0 of the first 3 cycles (every 28 days) and Day 0 of subsequent Cycles (every 6 months).
GVAX Pancreas Vaccine: Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
|
Cohort 1 (J0810 Arm C)
n=2 participants at risk
Patients coming from J0810 (NCT00727441) Patients receive oral CY and GVAX
Cyclophosphamide Pill: Cohort 1 patients (J0810 Arm C) will receive 50mg oral CY once a day starting 28 days prior to GVAX and for 28 days post-GVAX (every 6 months).
GVAX Pancreas Vaccine: Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
|
Cohort 2 (Vaccine Naive)
n=52 participants at risk
Patients receive IV CY and GVAX
Cyclophosphamide: Cohort 1 (J0810 Arm B), Cohort 3, Cohort 4, and Cohort 5 patients will receive 200mg/m\^2 CY administered IV on day 0 of each Cycle (every 6 months). Cohort 2 patients will receive 200mg/m\^2 CY administered IV on Day 0 of the first 3 cycles (every 28 days) and Day 0 of subsequent Cycles (every 6 months).
GVAX Pancreas Vaccine: Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
|
Cohort 3 (J1568)
n=6 participants at risk
Patients coming from J1568 (NCT02451982) Patients receive IV CY and GVAX
Cyclophosphamide: Cohort 1 (J0810 Arm B), Cohort 3, Cohort 4, and Cohort 5 patients will receive 200mg/m\^2 CY administered IV on day 0 of each Cycle (every 6 months). Cohort 2 patients will receive 200mg/m\^2 CY administered IV on Day 0 of the first 3 cycles (every 28 days) and Day 0 of subsequent Cycles (every 6 months).
GVAX Pancreas Vaccine: Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
|
Cohort 4 (J15237)
Patients coming from J15237 (NCT02648282) Patients receive IV CY and GVAX
Cyclophosphamide: Cohort 1 (J0810 Arm B), Cohort 3, Cohort 4, and Cohort 5 patients will receive 200mg/m\^2 CY administered IV on day 0 of each Cycle (every 6 months). Cohort 2 patients will receive 200mg/m\^2 CY administered IV on Day 0 of the first 3 cycles (every 28 days) and Day 0 of subsequent Cycles (every 6 months).
GVAX Pancreas Vaccine: Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
|
Cohort 5 (J1766)
Patients coming from J1766 (NCT03153410) Patients receive IV CY and GVAX
Cyclophosphamide: Cohort 1 (J0810 Arm B), Cohort 3, Cohort 4, and Cohort 5 patients will receive 200mg/m\^2 CY administered IV on day 0 of each Cycle (every 6 months). Cohort 2 patients will receive 200mg/m\^2 CY administered IV on Day 0 of the first 3 cycles (every 28 days) and Day 0 of subsequent Cycles (every 6 months).
GVAX Pancreas Vaccine: Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/8 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
1.9%
1/52 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/8 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
33.3%
1/3 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/52 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/8 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
1.9%
1/52 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
|
Hepatobiliary disorders
Cholongitis
|
0.00%
0/8 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
1.9%
1/52 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
|
Gastrointestinal disorders
FibroInflammatory lesion (pancreas)
|
12.5%
1/8 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/52 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
1.9%
1/52 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
|
Infections and infestations
Subacute Peritoneal Infection
|
0.00%
0/8 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
33.3%
1/3 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/52 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/8 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
1.9%
1/52 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
|
Infections and infestations
Sepsis
|
0.00%
0/8 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
3.8%
2/52 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
|
Gastrointestinal disorders
Small Bowel Obstruction
|
0.00%
0/8 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
1.9%
1/52 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
|
Metabolism and nutrition disorders
Vomiting
|
0.00%
0/8 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
3.8%
2/52 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
|
Investigations
Weight Loss
|
0.00%
0/8 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
1.9%
1/52 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
Other adverse events
| Measure |
Cohort 1 (J0810 Arm A)
n=8 participants at risk
Patients coming from J0810 (NCT00727441) Patients receive GVAX
GVAX Pancreas Vaccine: Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
|
Cohort 1 (J0810 Arm B)
n=3 participants at risk
Patients coming from J0810 (NCT00727441) Patients receive IV CY and GVAX
Cyclophosphamide: Cohort 1 (J0810 Arm B), Cohort 3, Cohort 4, and Cohort 5 patients will receive 200mg/m\^2 CY administered IV on day 0 of each Cycle (every 6 months). Cohort 2 patients will receive 200mg/m\^2 CY administered IV on Day 0 of the first 3 cycles (every 28 days) and Day 0 of subsequent Cycles (every 6 months).
GVAX Pancreas Vaccine: Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
|
Cohort 1 (J0810 Arm C)
n=2 participants at risk
Patients coming from J0810 (NCT00727441) Patients receive oral CY and GVAX
Cyclophosphamide Pill: Cohort 1 patients (J0810 Arm C) will receive 50mg oral CY once a day starting 28 days prior to GVAX and for 28 days post-GVAX (every 6 months).
GVAX Pancreas Vaccine: Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
|
Cohort 2 (Vaccine Naive)
n=52 participants at risk
Patients receive IV CY and GVAX
Cyclophosphamide: Cohort 1 (J0810 Arm B), Cohort 3, Cohort 4, and Cohort 5 patients will receive 200mg/m\^2 CY administered IV on day 0 of each Cycle (every 6 months). Cohort 2 patients will receive 200mg/m\^2 CY administered IV on Day 0 of the first 3 cycles (every 28 days) and Day 0 of subsequent Cycles (every 6 months).
GVAX Pancreas Vaccine: Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
|
Cohort 3 (J1568)
n=6 participants at risk
Patients coming from J1568 (NCT02451982) Patients receive IV CY and GVAX
Cyclophosphamide: Cohort 1 (J0810 Arm B), Cohort 3, Cohort 4, and Cohort 5 patients will receive 200mg/m\^2 CY administered IV on day 0 of each Cycle (every 6 months). Cohort 2 patients will receive 200mg/m\^2 CY administered IV on Day 0 of the first 3 cycles (every 28 days) and Day 0 of subsequent Cycles (every 6 months).
GVAX Pancreas Vaccine: Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
|
Cohort 4 (J15237)
Patients coming from J15237 (NCT02648282) Patients receive IV CY and GVAX
Cyclophosphamide: Cohort 1 (J0810 Arm B), Cohort 3, Cohort 4, and Cohort 5 patients will receive 200mg/m\^2 CY administered IV on day 0 of each Cycle (every 6 months). Cohort 2 patients will receive 200mg/m\^2 CY administered IV on Day 0 of the first 3 cycles (every 28 days) and Day 0 of subsequent Cycles (every 6 months).
GVAX Pancreas Vaccine: Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
|
Cohort 5 (J1766)
Patients coming from J1766 (NCT03153410) Patients receive IV CY and GVAX
Cyclophosphamide: Cohort 1 (J0810 Arm B), Cohort 3, Cohort 4, and Cohort 5 patients will receive 200mg/m\^2 CY administered IV on day 0 of each Cycle (every 6 months). Cohort 2 patients will receive 200mg/m\^2 CY administered IV on Day 0 of the first 3 cycles (every 28 days) and Day 0 of subsequent Cycles (every 6 months).
GVAX Pancreas Vaccine: Cohort 1, 3, 4, and 5 patients will receive GVAX on day 1 of each Cycle (every 6 months). Cohort 2 patients will receive GVAX on Day 1 of the first 3 cycles (every 28 days) and Day 1 of subsequent Cycles (every 6 months).
|
|---|---|---|---|---|---|---|---|
|
General disorders
Fatigue
|
12.5%
1/8 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
33.3%
1/3 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
71.2%
37/52 • Number of events 95 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
33.3%
2/6 • Number of events 4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
|
Gastrointestinal disorders
Abdominal Pain
|
12.5%
1/8 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
100.0%
2/2 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
13.5%
7/52 • Number of events 11 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
16.7%
1/6 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
|
Investigations
Alkaline Phosphatase Increased
|
0.00%
0/8 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
33.3%
1/3 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/52 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/8 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
9.6%
5/52 • Number of events 5 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
16.7%
1/6 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
|
General disorders
Chills
|
0.00%
0/8 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
50.0%
1/2 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
25.0%
13/52 • Number of events 27 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
16.7%
1/6 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/8 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
50.0%
1/2 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
11.5%
6/52 • Number of events 6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/8 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
7.7%
4/52 • Number of events 5 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
|
General disorders
Edema Face
|
12.5%
1/8 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
1.9%
1/52 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
|
General disorders
Edema Limb
|
0.00%
0/8 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
5.8%
3/52 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
16.7%
1/6 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
|
General disorders
Fever
|
12.5%
1/8 • Number of events 4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
23.1%
12/52 • Number of events 27 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
16.7%
1/6 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
|
General disorders
Flu-like Syndrome
|
0.00%
0/8 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
9.6%
5/52 • Number of events 13 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
32.7%
17/52 • Number of events 26 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
16.7%
1/6 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
|
Skin and subcutaneous tissue disorders
Hives
|
25.0%
2/8 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
9.6%
5/52 • Number of events 5 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
16.7%
1/6 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
12.5%
1/8 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
66.7%
2/3 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
7.7%
4/52 • Number of events 5 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
|
Investigations
Lymphocyte Count Decreased
|
12.5%
1/8 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
100.0%
2/2 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
50.0%
26/52 • Number of events 63 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
1/8 • Number of events 4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
21.2%
11/52 • Number of events 18 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
33.3%
2/6 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
33.3%
1/3 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
100.0%
2/2 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
46.2%
24/52 • Number of events 47 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
50.0%
3/6 • Number of events 6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
|
Investigations
Neutrophil Count Decreased
|
12.5%
1/8 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
15.4%
8/52 • Number of events 10 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.5%
1/8 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
7.7%
4/52 • Number of events 4 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
16.7%
1/6 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
5.8%
3/52 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
16.7%
1/6 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
9.6%
5/52 • Number of events 10 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
33.3%
2/6 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
|
Investigations
White Blood Cell Count Decreased
|
25.0%
2/8 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
34.6%
18/52 • Number of events 53 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/8 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
50.0%
1/2 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
1.9%
1/52 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/8 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
33.3%
1/3 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/52 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
50.0%
1/2 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
3.8%
2/52 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
|
General disorders
COVID infection
|
0.00%
0/8 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/52 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
16.7%
1/6 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
|
Investigations
Creatinine Increase
|
0.00%
0/8 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
33.3%
1/3 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/52 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
12.5%
1/8 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/52 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
5.8%
3/52 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
|
General disorders
Edema Tunk
|
12.5%
1/8 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/52 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
|
Vascular disorders
Hematoma
|
12.5%
1/8 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
1.9%
1/52 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
|
Respiratory, thoracic and mediastinal disorders
Voice Changes
|
12.5%
1/8 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/52 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
|
Vascular disorders
Hypertension
|
12.5%
1/8 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/52 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
|
Musculoskeletal and connective tissue disorders
Muscle Pull
|
12.5%
1/8 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/52 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Infection
|
0.00%
0/8 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
50.0%
1/2 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
3.8%
2/52 • Number of events 2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
12.5%
1/8 • Number of events 1 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/2 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
3.8%
2/52 • Number of events 3 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
0.00%
0/6 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
—
0/0 • Serious and Other (Not Including Serious) Adverse Events were evaluated for up to 121 months. All-cause mortality was evaluated for up to 133 months.
No patients were enrolled into Cohort 4 or Cohort 5
|
Additional Information
Daniel Laheru, MD
SKCCC Johns Hopkins Medical Institution
Phone: 410-955-8974
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place