Trial Outcomes & Findings for An Investigational Immuno-Therapy Study of Experimental Medication BMS-986277 Given Alone and in Combination With Nivolumab in Epithelial Cancers (NCT NCT03363776)
NCT ID: NCT03363776
Last Updated: 2020-12-19
Results Overview
Number of participants who experienced an AE during the course of the study.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
10 participants
Primary outcome timeframe
from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)
Results posted on
2020-12-19
Participant Flow
10 participants randomized and treated
Participant milestones
| Measure |
Arm A (Part 1)
BMS-986277 IV 3 X 10\^10
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm B (Part 1)
BMS-986277 IV 3 X 10\^11
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm C (Part 1)
BMS-986277 IV 1 X 10\^12
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
3
|
|
Overall Study
COMPLETED
|
1
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
2
|
Reasons for withdrawal
| Measure |
Arm A (Part 1)
BMS-986277 IV 3 X 10\^10
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm B (Part 1)
BMS-986277 IV 3 X 10\^11
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm C (Part 1)
BMS-986277 IV 1 X 10\^12
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
|---|---|---|---|
|
Overall Study
Progressive disease
|
2
|
3
|
1
|
|
Overall Study
Study drug toxicity
|
0
|
0
|
1
|
|
Overall Study
Death
|
1
|
0
|
0
|
Baseline Characteristics
An Investigational Immuno-Therapy Study of Experimental Medication BMS-986277 Given Alone and in Combination With Nivolumab in Epithelial Cancers
Baseline characteristics by cohort
| Measure |
Arm A (Part 1)
n=4 Participants
BMS-986277 IV 3 X 10\^10
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm B (Part 1)
n=3 Participants
BMS-986277 IV 3 X 10\^11
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm C (Part 1)
n=3 Participants
BMS-986277 IV 1 X 10\^12
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61 Years
STANDARD_DEVIATION 2.4 • n=5 Participants
|
59 Years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
47 Years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
57 Years
STANDARD_DEVIATION 9.9 • n=4 Participants
|
|
Age, Customized
> 65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Customized
<= 65 years
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 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
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
|
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
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
10 Participants
n=4 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
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)Population: All treated participants Study terminated, data not reported due to privacy reasons
Number of participants who experienced an AE during the course of the study.
Outcome measures
| Measure |
Arm A (Part 1)
n=4 Participants
BMS-986277 IV 3 X 10\^10
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm B (Part 1)
n=3 Participants
BMS-986277 IV 3 X 10\^11
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm C (Part 1)
n=3 Participants
BMS-986277 IV 1 X 10\^12
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
|---|---|---|---|
|
Number of Participants With an Adverse Event (AE)
|
NA Number of Participants
Study terminated, data not reported due to privacy reasons
|
NA Number of Participants
Study terminated, data not reported due to privacy reasons
|
NA Number of Participants
Study terminated, data not reported due to privacy reasons
|
PRIMARY outcome
Timeframe: from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)Population: All treated participants Study terminated, data not reported due to privacy reasons
Number of participants who experienced a SAE during the course of the study.
Outcome measures
| Measure |
Arm A (Part 1)
n=4 Participants
BMS-986277 IV 3 X 10\^10
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm B (Part 1)
n=3 Participants
BMS-986277 IV 3 X 10\^11
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm C (Part 1)
n=3 Participants
BMS-986277 IV 1 X 10\^12
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
|---|---|---|---|
|
Number of Participants With a Serious Adverse Event (SAE)
|
NA Number of Participants
Study terminated, data not reported due to privacy reasons
|
NA Number of Participants
Study terminated, data not reported due to privacy reasons
|
NA Number of Participants
Study terminated, data not reported due to privacy reasons
|
PRIMARY outcome
Timeframe: from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)Population: All treated participants Study terminated, data not reported due to privacy reasons
Number of participants who experienced an AE meeting protocol-defined DLT criteria during the course of the study.
Outcome measures
| Measure |
Arm A (Part 1)
n=4 Participants
BMS-986277 IV 3 X 10\^10
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm B (Part 1)
n=3 Participants
BMS-986277 IV 3 X 10\^11
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm C (Part 1)
n=3 Participants
BMS-986277 IV 1 X 10\^12
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
|---|---|---|---|
|
Number of Participants With an Adverse Event (AE) Meeting Protocol-defined Dose Limiting Toxicity (DLT) Criteria
|
NA Number of Participants
Study terminated, data not reported due to privacy reasons
|
NA Number of Participants
Study terminated, data not reported due to privacy reasons
|
NA Number of Participants
Study terminated, data not reported due to privacy reasons
|
PRIMARY outcome
Timeframe: from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)Population: All treated participants Study terminated, data not reported due to privacy reasons
Number of participants who experienced an AE leading to discontinuation during the course of the study.
Outcome measures
| Measure |
Arm A (Part 1)
n=4 Participants
BMS-986277 IV 3 X 10\^10
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm B (Part 1)
n=3 Participants
BMS-986277 IV 3 X 10\^11
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm C (Part 1)
n=3 Participants
BMS-986277 IV 1 X 10\^12
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
|---|---|---|---|
|
Number of Participants With an Adverse Event (AE) Leading to Discontinuation
|
NA Number of Participants
Study terminated, data not reported due to privacy reasons
|
NA Number of Participants
Study terminated, data not reported due to privacy reasons
|
NA Number of Participants
Study terminated, data not reported due to privacy reasons
|
PRIMARY outcome
Timeframe: from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)Population: All treated participants Study terminated, data not reported due to privacy reasons
Number of participants who experienced an AE leading to death during the course of the study.
Outcome measures
| Measure |
Arm A (Part 1)
n=4 Participants
BMS-986277 IV 3 X 10\^10
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm B (Part 1)
n=3 Participants
BMS-986277 IV 3 X 10\^11
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm C (Part 1)
n=3 Participants
BMS-986277 IV 1 X 10\^12
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
|---|---|---|---|
|
Number of Participants With an Adverse Event (AE) Leading to Death
|
NA Number of Participants
Study terminated, data not reported due to privacy reasons
|
NA Number of Participants
Study terminated, data not reported due to privacy reasons
|
NA Number of Participants
Study terminated, data not reported due to privacy reasons
|
PRIMARY outcome
Timeframe: from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)Population: All treated participants Study terminated, data not reported due to privacy reasons
Number of participants who experienced a clinical laboratory test abnormality during the course of the study.
Outcome measures
| Measure |
Arm A (Part 1)
n=4 Participants
BMS-986277 IV 3 X 10\^10
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm B (Part 1)
n=3 Participants
BMS-986277 IV 3 X 10\^11
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm C (Part 1)
n=3 Participants
BMS-986277 IV 1 X 10\^12
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
|---|---|---|---|
|
Number of Participants With a Clinical Laboratory Test Abnormality
|
NA Number of Participants
Study terminated, data not reported due to privacy reasons
|
NA Number of Participants
Study terminated, data not reported due to privacy reasons
|
NA Number of Participants
Study terminated, data not reported due to privacy reasons
|
PRIMARY outcome
Timeframe: from first dose to 60 days post last dose, assessed up to February 2020 (approx. 26 months)Population: All treated participants Study terminated, data not reported due to privacy reasons
Number of participants who experienced a vital sign abnormality or other safety biomarkers during the course of the study.
Outcome measures
| Measure |
Arm A (Part 1)
n=4 Participants
BMS-986277 IV 3 X 10\^10
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm B (Part 1)
n=3 Participants
BMS-986277 IV 3 X 10\^11
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm C (Part 1)
n=3 Participants
BMS-986277 IV 1 X 10\^12
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
|---|---|---|---|
|
Number of Participants With a Vital Sign Abnormality or Other Safety Biomarkers
|
NA Number of Participants
Study terminated, data not reported due to privacy reasons
|
NA Number of Participants
Study terminated, data not reported due to privacy reasons
|
NA Number of Participants
Study terminated, data not reported due to privacy reasons
|
SECONDARY outcome
Timeframe: at Weeks 8, 16 and 24Population: All treated participants Study terminated, data not reported due to privacy reasons
ORR is defined as the proportion of all treated participants whose BOR is either CR or PR. BOR was determined by investigators for the reported data. Estimate of ORR and corresponding 2-sided exact 95% CI using the Clopper-Pearson method
Outcome measures
| Measure |
Arm A (Part 1)
n=4 Participants
BMS-986277 IV 3 X 10\^10
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm B (Part 1)
n=3 Participants
BMS-986277 IV 3 X 10\^11
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm C (Part 1)
n=3 Participants
BMS-986277 IV 1 X 10\^12
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
|---|---|---|---|
|
Objective Response Rate (ORR)
|
NA Percentage of Participants
Study terminated, data not reported due to privacy reasons
|
NA Percentage of Participants
Study terminated, data not reported due to privacy reasons
|
NA Percentage of Participants
Study terminated, data not reported due to privacy reasons
|
SECONDARY outcome
Timeframe: at Weeks 8, 16 and 24Population: All treated participants Study terminated, data not reported due to privacy reasons
DCR includes complete response (CR), partial response (PR), and stable disease (SD). Estimate of DCR and corresponding 2-sided exact 95% CI using the Clopper-Pearson method
Outcome measures
| Measure |
Arm A (Part 1)
n=4 Participants
BMS-986277 IV 3 X 10\^10
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm B (Part 1)
n=3 Participants
BMS-986277 IV 3 X 10\^11
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm C (Part 1)
n=3 Participants
BMS-986277 IV 1 X 10\^12
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
|---|---|---|---|
|
Disease Control Rate (DCR)
|
NA Percentage of Participants
Study terminated, data not reported due to privacy reasons
|
NA Percentage of Participants
Study terminated, data not reported due to privacy reasons
|
NA Percentage of Participants
Study terminated, data not reported due to privacy reasons
|
SECONDARY outcome
Timeframe: at Weeks 8, 16 and 24Population: All treated participants Study terminated, data not reported due to privacy reasons
DOR for a participant with a BOR of CR or PR is defined as the time between the date of first response and the date of the first objectively documented tumor progression per RECIST v1.1/PCWG3 or death, whichever occurs first. Estimate by the Kaplan-Meier method and corresponding 2-sided 95% CI using Brookmeyer and Crowley methodology (using log-log transformation)
Outcome measures
| Measure |
Arm A (Part 1)
n=4 Participants
BMS-986277 IV 3 X 10\^10
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm B (Part 1)
n=3 Participants
BMS-986277 IV 3 X 10\^11
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm C (Part 1)
n=3 Participants
BMS-986277 IV 1 X 10\^12
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
|---|---|---|---|
|
Median Duration of Response (mDOR)
|
NA Number of Participants
Study terminated, data not reported due to privacy reasons
|
NA Number of Participants
Study terminated, data not reported due to privacy reasons
|
NA Number of Participants
Study terminated, data not reported due to privacy reasons
|
SECONDARY outcome
Timeframe: at Weeks 8, 16 and 24, to progressionPopulation: All treated participants Study terminated, data not reported due to privacy reasons
PFS for a participant is defined as the time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurs first. Estimate by the Kaplan-Meier method and corresponding 2-sided 95% CI using Brookmeyer and Crowley methodology (using log-log transformation) for the median and Greenwood formula for the rate.
Outcome measures
| Measure |
Arm A (Part 1)
n=4 Participants
BMS-986277 IV 3 X 10\^10
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm B (Part 1)
n=3 Participants
BMS-986277 IV 3 X 10\^11
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm C (Part 1)
n=3 Participants
BMS-986277 IV 1 X 10\^12
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
|---|---|---|---|
|
Median Progression-Free Survival (mPFS)
|
NA Number of Participants
Study terminated, data not reported due to privacy reasons
|
NA Number of Participants
Study terminated, data not reported due to privacy reasons
|
NA Number of Participants
Study terminated, data not reported due to privacy reasons
|
SECONDARY outcome
Timeframe: at Weeks 8, 16 and 24Population: All treated participants Study terminated, data not reported due to privacy reasons
PFS for a participant is defined as the time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurs first. Estimate by the Kaplan-Meier method and corresponding 2-sided 95% CI using Brookmeyer and Crowley methodology (using log-log transformation) for the median and Greenwood formula for the rate.
Outcome measures
| Measure |
Arm A (Part 1)
n=4 Participants
BMS-986277 IV 3 X 10\^10
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm B (Part 1)
n=3 Participants
BMS-986277 IV 3 X 10\^11
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm C (Part 1)
n=3 Participants
BMS-986277 IV 1 X 10\^12
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
|---|---|---|---|
|
Progression-Free Survival Rate (PFSR)
|
NA Percentage of Participants
Study terminated, data not reported due to privacy reasons
|
NA Percentage of Participants
Study terminated, data not reported due to privacy reasons
|
NA Percentage of Participants
Study terminated, data not reported due to privacy reasons
|
SECONDARY outcome
Timeframe: Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visitsPopulation: All treated participants Study terminated, data not reported due to privacy reasons
Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. Cmax is defined as the maximum observed blood concentration.
Outcome measures
| Measure |
Arm A (Part 1)
n=4 Participants
BMS-986277 IV 3 X 10\^10
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm B (Part 1)
n=3 Participants
BMS-986277 IV 3 X 10\^11
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm C (Part 1)
n=3 Participants
BMS-986277 IV 1 X 10\^12
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
|---|---|---|---|
|
Cmax
|
NA µg/mL
Geometric Coefficient of Variation NA
Study terminated, data not reported due to privacy reasons
|
NA µg/mL
Geometric Coefficient of Variation NA
Study terminated, data not reported due to privacy reasons
|
NA µg/mL
Geometric Coefficient of Variation NA
Study terminated, data not reported due to privacy reasons
|
SECONDARY outcome
Timeframe: Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visitsPopulation: All treated participants Study terminated, data not reported due to privacy reasons
Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. Tmax is defined as the time of maximum observed blood concentration.
Outcome measures
| Measure |
Arm A (Part 1)
n=4 Participants
BMS-986277 IV 3 X 10\^10
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm B (Part 1)
n=3 Participants
BMS-986277 IV 3 X 10\^11
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm C (Part 1)
n=3 Participants
BMS-986277 IV 1 X 10\^12
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
|---|---|---|---|
|
Tmax
|
NA hour
Study terminated, data not reported due to privacy reasons
|
NA hour
Study terminated, data not reported due to privacy reasons
|
NA hour
Study terminated, data not reported due to privacy reasons
|
SECONDARY outcome
Timeframe: Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visitsPopulation: All treated participants Study terminated, data not reported due to privacy reasons
Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. AUC(0-T) is the area under the blood concentration-time curve from time zero to time of last quantifiable concentration.
Outcome measures
| Measure |
Arm A (Part 1)
n=4 Participants
BMS-986277 IV 3 X 10\^10
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm B (Part 1)
n=3 Participants
BMS-986277 IV 3 X 10\^11
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm C (Part 1)
n=3 Participants
BMS-986277 IV 1 X 10\^12
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
|---|---|---|---|
|
AUC(0-T)
|
NA µg.h/mL
Geometric Coefficient of Variation NA
Study terminated, data not reported due to privacy reasons
|
NA µg.h/mL
Geometric Coefficient of Variation NA
Study terminated, data not reported due to privacy reasons
|
NA µg.h/mL
Geometric Coefficient of Variation NA
Study terminated, data not reported due to privacy reasons
|
SECONDARY outcome
Timeframe: Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visitsPopulation: All treated participants Study terminated, data not reported due to privacy reasons
Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. AUC(INF) is the area under the blood concentration-time curve from time zero extrapolated to infinite time.
Outcome measures
| Measure |
Arm A (Part 1)
n=4 Participants
BMS-986277 IV 3 X 10\^10
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm B (Part 1)
n=3 Participants
BMS-986277 IV 3 X 10\^11
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm C (Part 1)
n=3 Participants
BMS-986277 IV 1 X 10\^12
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
|---|---|---|---|
|
AUC(INF)
|
NA µg.h/mL
Geometric Coefficient of Variation NA
Study terminated, data not reported due to privacy reasons
|
NA µg.h/mL
Geometric Coefficient of Variation NA
Study terminated, data not reported due to privacy reasons
|
NA µg.h/mL
Geometric Coefficient of Variation NA
Study terminated, data not reported due to privacy reasons
|
SECONDARY outcome
Timeframe: Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visitsPopulation: All treated participants Study terminated, data not reported due to privacy reasons
Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. T-HALF is defined as the apparent terminal half-life.
Outcome measures
| Measure |
Arm A (Part 1)
n=4 Participants
BMS-986277 IV 3 X 10\^10
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm B (Part 1)
n=3 Participants
BMS-986277 IV 3 X 10\^11
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm C (Part 1)
n=3 Participants
BMS-986277 IV 1 X 10\^12
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
|---|---|---|---|
|
T-HALF
|
NA hour
Standard Deviation NA
Study terminated, data not reported due to privacy reasons
|
NA hour
Standard Deviation NA
Study terminated, data not reported due to privacy reasons
|
NA hour
Standard Deviation NA
Study terminated, data not reported due to privacy reasons
|
SECONDARY outcome
Timeframe: Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visitsPopulation: All treated participants Study terminated, data not reported due to privacy reasons
Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. CLT is defined as the total body clearance.
Outcome measures
| Measure |
Arm A (Part 1)
n=4 Participants
BMS-986277 IV 3 X 10\^10
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm B (Part 1)
n=3 Participants
BMS-986277 IV 3 X 10\^11
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm C (Part 1)
n=3 Participants
BMS-986277 IV 1 X 10\^12
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
|---|---|---|---|
|
CLT
|
NA liter
Geometric Coefficient of Variation NA
Study terminated, data not reported due to privacy reasons
|
NA liter
Geometric Coefficient of Variation NA
Study terminated, data not reported due to privacy reasons
|
NA liter
Geometric Coefficient of Variation NA
Study terminated, data not reported due to privacy reasons
|
SECONDARY outcome
Timeframe: Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visitsPopulation: All treated participants Study terminated, data not reported due to privacy reasons
Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. Vss is defined as the volume of distribution at steady-state.
Outcome measures
| Measure |
Arm A (Part 1)
n=4 Participants
BMS-986277 IV 3 X 10\^10
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm B (Part 1)
n=3 Participants
BMS-986277 IV 3 X 10\^11
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm C (Part 1)
n=3 Participants
BMS-986277 IV 1 X 10\^12
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
|---|---|---|---|
|
Vss
|
NA liter
Geometric Coefficient of Variation NA
Study terminated, data not reported due to privacy reasons
|
NA liter
Geometric Coefficient of Variation NA
Study terminated, data not reported due to privacy reasons
|
NA liter
Geometric Coefficient of Variation NA
Study terminated, data not reported due to privacy reasons
|
SECONDARY outcome
Timeframe: Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visitsPopulation: All treated participants Study terminated, data not reported due to privacy reasons
Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. Vz is defined as the volume of distribution of the elimination phase.
Outcome measures
| Measure |
Arm A (Part 1)
n=4 Participants
BMS-986277 IV 3 X 10\^10
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm B (Part 1)
n=3 Participants
BMS-986277 IV 3 X 10\^11
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm C (Part 1)
n=3 Participants
BMS-986277 IV 1 X 10\^12
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
|---|---|---|---|
|
Vz
|
NA liter
Geometric Coefficient of Variation NA
Study terminated, data not reported due to privacy reasons
|
NA liter
Geometric Coefficient of Variation NA
Study terminated, data not reported due to privacy reasons
|
NA liter
Geometric Coefficient of Variation NA
Study terminated, data not reported due to privacy reasons
|
SECONDARY outcome
Timeframe: Cycle 1 (from time zero to 48 hours postdose)Population: All treated participants Study terminated, data not reported due to privacy reasons
Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. AUC(0-T) is the area under the blood concentration-time curve from time zero to 48 hours postdose
Outcome measures
| Measure |
Arm A (Part 1)
n=4 Participants
BMS-986277 IV 3 X 10\^10
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm B (Part 1)
n=3 Participants
BMS-986277 IV 3 X 10\^11
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm C (Part 1)
n=3 Participants
BMS-986277 IV 1 X 10\^12
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
|---|---|---|---|
|
AUC(0-48)
|
NA µg.h/mL
Geometric Coefficient of Variation NA
Study terminated, data not reported due to privacy reasons
|
NA µg.h/mL
Geometric Coefficient of Variation NA
Study terminated, data not reported due to privacy reasons
|
NA µg.h/mL
Geometric Coefficient of Variation NA
Study terminated, data not reported due to privacy reasons
|
SECONDARY outcome
Timeframe: Cycle 1 (from time zero to 8 hours postdose)Population: All treated participants Study terminated, data not reported due to privacy reasons
Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. AUC(0-T) is the area under the blood concentration-time curve from time zero to 8 hours postdose
Outcome measures
| Measure |
Arm A (Part 1)
n=4 Participants
BMS-986277 IV 3 X 10\^10
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm B (Part 1)
n=3 Participants
BMS-986277 IV 3 X 10\^11
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm C (Part 1)
n=3 Participants
BMS-986277 IV 1 X 10\^12
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
|---|---|---|---|
|
AUC(0-8)
|
NA µg.h/mL
Geometric Coefficient of Variation NA
Study terminated, data not reported due to privacy reasons
|
NA µg.h/mL
Geometric Coefficient of Variation NA
Study terminated, data not reported due to privacy reasons
|
NA µg.h/mL
Geometric Coefficient of Variation NA
Study terminated, data not reported due to privacy reasons
|
SECONDARY outcome
Timeframe: Cycle 1 at 48 hours postdosePopulation: All treated participants Study terminated, data not reported due to privacy reasons
Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. C48 is defined as the blood concentration at 48 hours postdose.
Outcome measures
| Measure |
Arm A (Part 1)
n=4 Participants
BMS-986277 IV 3 X 10\^10
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm B (Part 1)
n=3 Participants
BMS-986277 IV 3 X 10\^11
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm C (Part 1)
n=3 Participants
BMS-986277 IV 1 X 10\^12
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
|---|---|---|---|
|
C48
|
NA µg/mL
Geometric Coefficient of Variation NA
Study terminated, data not reported due to privacy reasons
|
NA µg/mL
Geometric Coefficient of Variation NA
Study terminated, data not reported due to privacy reasons
|
NA µg/mL
Geometric Coefficient of Variation NA
Study terminated, data not reported due to privacy reasons
|
SECONDARY outcome
Timeframe: Cycle 1 (from time zero to 48 hours postdose)Population: All treated participants Study terminated, data not reported due to privacy reasons
Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. Css-avg is defined as the average blood concentration over a dosing interval at steady state (AUC\[0-48\]/48).
Outcome measures
| Measure |
Arm A (Part 1)
n=4 Participants
BMS-986277 IV 3 X 10\^10
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm B (Part 1)
n=3 Participants
BMS-986277 IV 3 X 10\^11
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm C (Part 1)
n=3 Participants
BMS-986277 IV 1 X 10\^12
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
|---|---|---|---|
|
Css-avg
|
NA µg/mL
Geometric Coefficient of Variation NA
Study terminated, data not reported due to privacy reasons
|
NA µg/mL
Geometric Coefficient of Variation NA
Study terminated, data not reported due to privacy reasons
|
NA µg/mL
Geometric Coefficient of Variation NA
Study terminated, data not reported due to privacy reasons
|
SECONDARY outcome
Timeframe: Cycle 1 (Day 19, Day 15)Population: All treated participants Study terminated, data not reported due to privacy reasons
Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. AUC accumulation index; ratio of AUC(0-48) on Cycle 1 Day 19 to AUC(0-48) on Cycle 1 Day 15 for monotherapy.
Outcome measures
| Measure |
Arm A (Part 1)
n=4 Participants
BMS-986277 IV 3 X 10\^10
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm B (Part 1)
n=3 Participants
BMS-986277 IV 3 X 10\^11
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm C (Part 1)
n=3 Participants
BMS-986277 IV 1 X 10\^12
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
|---|---|---|---|
|
AI_AUC
|
NA ratio AUC(0-48),C1D19 to AUC(0-48),C1D15
Geometric Coefficient of Variation NA
Study terminated, data not reported due to privacy reasons
|
NA ratio AUC(0-48),C1D19 to AUC(0-48),C1D15
Geometric Coefficient of Variation NA
Study terminated, data not reported due to privacy reasons
|
NA ratio AUC(0-48),C1D19 to AUC(0-48),C1D15
Geometric Coefficient of Variation NA
Study terminated, data not reported due to privacy reasons
|
SECONDARY outcome
Timeframe: Cycle 1 (Day 19, Day 15)Population: All treated participants Study terminated, data not reported due to privacy reasons
Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. Cmax accumulation index; ratio of Cmax on Cycle 1 Day 19 to Cmax on Cycle 1 Day 15 for monotherapy.
Outcome measures
| Measure |
Arm A (Part 1)
n=4 Participants
BMS-986277 IV 3 X 10\^10
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm B (Part 1)
n=3 Participants
BMS-986277 IV 3 X 10\^11
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm C (Part 1)
n=3 Participants
BMS-986277 IV 1 X 10\^12
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
|---|---|---|---|
|
AI_Cmax
|
NA ratio of Cmax,C1D19 to Cmax,C1D15
Geometric Coefficient of Variation NA
Study terminated, data not reported due to privacy reasons
|
NA ratio of Cmax,C1D19 to Cmax,C1D15
Geometric Coefficient of Variation NA
Study terminated, data not reported due to privacy reasons
|
NA ratio of Cmax,C1D19 to Cmax,C1D15
Geometric Coefficient of Variation NA
Study terminated, data not reported due to privacy reasons
|
SECONDARY outcome
Timeframe: Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visitsPopulation: All treated participants Study terminated, data not reported due to privacy reasons
Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. T-HALFeff is defined as effective elimination half-life that explains the degree of accumulation observed for a specific exposure measure (exposure measure includes AUC, Cmax)
Outcome measures
| Measure |
Arm A (Part 1)
n=4 Participants
BMS-986277 IV 3 X 10\^10
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm B (Part 1)
n=3 Participants
BMS-986277 IV 3 X 10\^11
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm C (Part 1)
n=3 Participants
BMS-986277 IV 1 X 10\^12
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
|---|---|---|---|
|
T-HALFeff
|
NA hour
Study terminated, data not reported due to privacy reasons
|
NA hour
Study terminated, data not reported due to privacy reasons
|
NA hour
Study terminated, data not reported due to privacy reasons
|
SECONDARY outcome
Timeframe: Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visitsPopulation: All treated participants Study terminated, data not reported due to privacy reasons
Pharmacokinetics of BMS-986277 were derived from blood concentration versus time data. Ctrough is defined as the trough observed blood concentration.
Outcome measures
| Measure |
Arm A (Part 1)
n=4 Participants
BMS-986277 IV 3 X 10\^10
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm B (Part 1)
n=3 Participants
BMS-986277 IV 3 X 10\^11
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm C (Part 1)
n=3 Participants
BMS-986277 IV 1 X 10\^12
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
|---|---|---|---|
|
Ctrough
|
NA µg/mL
Geometric Coefficient of Variation NA
Study terminated, data not reported due to privacy reasons
|
NA µg/mL
Geometric Coefficient of Variation NA
Study terminated, data not reported due to privacy reasons
|
NA µg/mL
Geometric Coefficient of Variation NA
Study terminated, data not reported due to privacy reasons
|
SECONDARY outcome
Timeframe: Cycle 1 (Day 1 pre-dose through Day 29, 240 hour), Cycle 2 (Day 1 pre-dose through Day 22, 408 hour); through Follow-up visitsPopulation: All treated participants Study terminated, data not reported due to privacy reasons
Baseline ADA-positive participant is defined as a participant who has an ADA-detected sample at baseline. ADA-positive participant is a participant with at least 1 ADA-positive sample relative to baseline after initiation of the treatment. Frequency distribution of baseline ADA-positive participants and ADA-positive participants after initiation of the treatment
Outcome measures
| Measure |
Arm A (Part 1)
n=4 Participants
BMS-986277 IV 3 X 10\^10
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm B (Part 1)
n=3 Participants
BMS-986277 IV 3 X 10\^11
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm C (Part 1)
n=3 Participants
BMS-986277 IV 1 X 10\^12
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
|---|---|---|---|
|
Number of Participants With a Positive Antibody-Drug-Antibody (ADA) Response
|
NA Number of participants
Study terminated, data not reported due to privacy reasons
|
NA Number of participants
Study terminated, data not reported due to privacy reasons
|
NA Number of participants
Study terminated, data not reported due to privacy reasons
|
Adverse Events
Arm A (Part 1)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 2 deaths
Arm B (Part 1)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
Arm C (Part 1)
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Arm A (Part 1)
n=4 participants at risk
BMS-986277 IV 3 X 10\^10
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm B (Part 1)
n=3 participants at risk
BMS-986277 IV 3 X 10\^11
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm C (Part 1)
n=3 participants at risk
BMS-986277 IV 1 X 10\^12
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
|---|---|---|---|
|
Gastrointestinal disorders
Ascites
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
66.7%
2/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
Other adverse events
| Measure |
Arm A (Part 1)
n=4 participants at risk
BMS-986277 IV 3 X 10\^10
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm B (Part 1)
n=3 participants at risk
BMS-986277 IV 3 X 10\^11
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
Arm C (Part 1)
n=3 participants at risk
BMS-986277 IV 1 X 10\^12
Cycle 1 of BMS-986277 will be administered as a single IV infusion (D1) before proceeding to sequential dosing (consisting of 3 doses administered on Days 15, 17, and 19). A minimum of 24 hours is required between doses of BMS-986277.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
2/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
|
Gastrointestinal disorders
Lip ulceration
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
|
Gastrointestinal disorders
Nausea
|
75.0%
3/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
66.7%
2/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
66.7%
2/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
|
General disorders
Chills
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
66.7%
2/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
|
General disorders
Fatigue
|
50.0%
2/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
100.0%
3/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
|
General disorders
Influenza like illness
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
66.7%
2/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
|
General disorders
Oedema peripheral
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
|
General disorders
Pyrexia
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
100.0%
3/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
|
Immune system disorders
Cytokine release syndrome
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
|
Infections and infestations
Urinary tract infection
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
|
Investigations
Alanine aminotransferase increased
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
|
Investigations
Amylase increased
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
|
Investigations
Aspartate aminotransferase increased
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
|
Investigations
Blood bilirubin increased
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
|
Investigations
Lipase increased
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
2/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
66.7%
2/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
66.7%
2/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
|
Nervous system disorders
Sciatica
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
|
Renal and urinary disorders
Hypertonic bladder
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
|
Renal and urinary disorders
Micturition urgency
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
|
Reproductive system and breast disorders
Haematospermia
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
1/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
|
Vascular disorders
Hot flush
|
0.00%
0/4 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
0.00%
0/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
33.3%
1/3 • AEs/SAEs are collected from the first dose date until the last dose date + 100 days, assessed up to February 2020 (approx. 26 months)
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: please email:
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60