Trial Outcomes & Findings for An Investigational Immuno-Therapy Study of Experimental Medication BMS-986242 Given in Combination With Nivolumab in Patients With Advanced Cancer (NCT NCT03351231)
NCT ID: NCT03351231
Last Updated: 2020-08-26
Results Overview
The primary objective to establish safety to be measured by the primary endpoint of AEs
TERMINATED
PHASE1/PHASE2
7 participants
From initiation of study treatment until 100 days after discontinuation of study treatment
2020-08-26
Participant Flow
7 participants were enrolled and 5 of those participants entered treatment; reasons for 2 participants not entering treatment were due to: 1 death; 1 participant no longer met study criteria. Note: study terminated following starting dose of BMS-986242 12.5 mg; dosing did not escalate.
Participant milestones
| Measure |
BMS-986242 12.5 mg + Nivolumab 480 mg
2-week monotherapy of BMS986-242 (Cycle 0), followed by combination treatment cycles every 4 weeks for 104 weeks (or 26 cycles); each treatment cycle consists of daily oral dose of BMS-986242 and 1 dose of Nivolumab intravenously every 4 weeks on Day 1 of treatment cycle; every 2 treatment cycles decision may be made to add cycles of study treatment based on radiological tumor assessments
|
|---|---|
|
Combination Therapy Period
STARTED
|
5
|
|
Combination Therapy Period
COMPLETED
|
0
|
|
Combination Therapy Period
NOT COMPLETED
|
5
|
|
Safety Follow-Up Period
STARTED
|
3
|
|
Safety Follow-Up Period
COMPLETED
|
0
|
|
Safety Follow-Up Period
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
BMS-986242 12.5 mg + Nivolumab 480 mg
2-week monotherapy of BMS986-242 (Cycle 0), followed by combination treatment cycles every 4 weeks for 104 weeks (or 26 cycles); each treatment cycle consists of daily oral dose of BMS-986242 and 1 dose of Nivolumab intravenously every 4 weeks on Day 1 of treatment cycle; every 2 treatment cycles decision may be made to add cycles of study treatment based on radiological tumor assessments
|
|---|---|
|
Combination Therapy Period
Administrative reason by the Sponsor
|
1
|
|
Combination Therapy Period
Disease progression
|
2
|
|
Combination Therapy Period
Study drug toxicity
|
1
|
|
Combination Therapy Period
Adverse Event unrelated to study drug
|
1
|
|
Safety Follow-Up Period
Participant withdrew consent
|
1
|
|
Safety Follow-Up Period
Other reason
|
2
|
Baseline Characteristics
An Investigational Immuno-Therapy Study of Experimental Medication BMS-986242 Given in Combination With Nivolumab in Patients With Advanced Cancer
Baseline characteristics by cohort
| Measure |
BMS-986242 12.5 mg + Nivolumab 480 mg
n=5 Participants
2-week monotherapy of BMS986-242 (Cycle 0), followed by combination treatment cycles every 4 weeks for 104 weeks (or 26 cycles); each treatment cycle consists of daily oral dose of BMS-986242 and 1 dose of Nivolumab intravenously every 4 weeks on Day 1 of treatment cycle; every 2 treatment cycles decision may be made to add cycles of study treatment based on radiological tumor assessments
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
|
Age, Continuous
|
67.8 Years
STANDARD_DEVIATION 7.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From initiation of study treatment until 100 days after discontinuation of study treatmentPopulation: Study terminated, data not reported due to privacy reasons
The primary objective to establish safety to be measured by the primary endpoint of AEs
Outcome measures
| Measure |
BMS-986242 12.5 mg + Nivolumab 480 mg
n=5 Participants
2-week monotherapy of BMS986-242 (Cycle 0), followed by combination treatment cycles every 4 weeks for 104 weeks (or 26 cycles); each treatment cycle consists of daily oral dose of BMS-986242 and 1 dose of Nivolumab intravenously every 4 weeks on Day 1 of treatment cycle; every 2 treatment cycles decision may be made to add cycles of study treatment based on radiological tumor assessments
|
|---|---|
|
Number of Participants With Adverse Events (AE)
|
NA Number of participants
Study terminated, data not reported due to privacy reasons
|
PRIMARY outcome
Timeframe: From the date of participant's written consent until 100 days after discontinuation of nivolumab or participation in the studyPopulation: Study terminated, data not reported due to privacy reasons
The primary objective to establish safety to be measured by the primary endpoint of SAEs
Outcome measures
| Measure |
BMS-986242 12.5 mg + Nivolumab 480 mg
n=5 Participants
2-week monotherapy of BMS986-242 (Cycle 0), followed by combination treatment cycles every 4 weeks for 104 weeks (or 26 cycles); each treatment cycle consists of daily oral dose of BMS-986242 and 1 dose of Nivolumab intravenously every 4 weeks on Day 1 of treatment cycle; every 2 treatment cycles decision may be made to add cycles of study treatment based on radiological tumor assessments
|
|---|---|
|
Number of Participants With Serious Adverse Events (SAE)
|
NA Number of participants
Study terminated, data not reported due to privacy reasons
|
PRIMARY outcome
Timeframe: Approximately 2 yearsPopulation: Study terminated, data not reported due to privacy reasons
The primary objective to establish safety to be measured by the primary endpoint of dose limiting toxicities
Outcome measures
| Measure |
BMS-986242 12.5 mg + Nivolumab 480 mg
n=5 Participants
2-week monotherapy of BMS986-242 (Cycle 0), followed by combination treatment cycles every 4 weeks for 104 weeks (or 26 cycles); each treatment cycle consists of daily oral dose of BMS-986242 and 1 dose of Nivolumab intravenously every 4 weeks on Day 1 of treatment cycle; every 2 treatment cycles decision may be made to add cycles of study treatment based on radiological tumor assessments
|
|---|---|
|
Number of Participants With Dose Limiting Toxicities (DLT)
|
NA Number of participants
Study terminated, data not reported due to privacy reasons
|
PRIMARY outcome
Timeframe: Approximately 2 yearsPopulation: Study terminated, data not reported due to privacy reasons
The primary objective to establish safety to be measured by the primary endpoint of AEs leading to discontinuation
Outcome measures
| Measure |
BMS-986242 12.5 mg + Nivolumab 480 mg
n=5 Participants
2-week monotherapy of BMS986-242 (Cycle 0), followed by combination treatment cycles every 4 weeks for 104 weeks (or 26 cycles); each treatment cycle consists of daily oral dose of BMS-986242 and 1 dose of Nivolumab intravenously every 4 weeks on Day 1 of treatment cycle; every 2 treatment cycles decision may be made to add cycles of study treatment based on radiological tumor assessments
|
|---|---|
|
Number of Participants With AEs Leading to Discontinuation
|
NA Number of participants
Study terminated, data not reported due to privacy reasons
|
PRIMARY outcome
Timeframe: Approximately 2 yearsPopulation: Study terminated, data not reported due to privacy reasons
The primary objective to establish safety to be measured by the primary endpoint of deaths
Outcome measures
| Measure |
BMS-986242 12.5 mg + Nivolumab 480 mg
n=5 Participants
2-week monotherapy of BMS986-242 (Cycle 0), followed by combination treatment cycles every 4 weeks for 104 weeks (or 26 cycles); each treatment cycle consists of daily oral dose of BMS-986242 and 1 dose of Nivolumab intravenously every 4 weeks on Day 1 of treatment cycle; every 2 treatment cycles decision may be made to add cycles of study treatment based on radiological tumor assessments
|
|---|---|
|
Number of Deaths
|
NA Number of deaths
Study terminated, data not reported due to privacy reasons
|
PRIMARY outcome
Timeframe: Approximately 2 yearsPopulation: Study terminated, data not reported due to privacy reasons
The primary objective to establish safety to be measured by the primary endpoint of clinical laboratory test abnormalities
Outcome measures
| Measure |
BMS-986242 12.5 mg + Nivolumab 480 mg
n=5 Participants
2-week monotherapy of BMS986-242 (Cycle 0), followed by combination treatment cycles every 4 weeks for 104 weeks (or 26 cycles); each treatment cycle consists of daily oral dose of BMS-986242 and 1 dose of Nivolumab intravenously every 4 weeks on Day 1 of treatment cycle; every 2 treatment cycles decision may be made to add cycles of study treatment based on radiological tumor assessments
|
|---|---|
|
Number of Participants With Laboratory Abnormalities
|
NA Number of participants
Study terminated, data not reported due to privacy reasons
|
SECONDARY outcome
Timeframe: Approximately 2 yearsPopulation: Study terminated, data not reported due to privacy reasons
The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 2 yearsPopulation: Study terminated, data not reported due to privacy reasons
The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 2 yearsPopulation: Study terminated, data not reported due to privacy reasons
The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 2 yearsPopulation: Study terminated, data not reported due to privacy reasons
The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 2 yearsPopulation: Study terminated, data not reported due to privacy reasons
The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 2 yearsPopulation: Study terminated, data not reported due to privacy reasons
The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 2 yearsPopulation: Study terminated, data not reported due to privacy reasons
The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 2 yearsPopulation: Study terminated, data not reported due to privacy reasons
The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 2 yearsPopulation: Study terminated, data not reported due to privacy reasons
The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0. Accumulation index, calculated based on ratio of area under the curve (AUC) and Cmax at steady state to after the first dose.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 2 yearsPopulation: Study terminated, data not reported due to privacy reasons
The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 2 yearsPopulation: Study terminated, data not reported due to privacy reasons
The Pharmacokinetic (PK) parameters are assessed for BMS-986242 and selected metabolites following single-dose administration in Cycle 00 and multiple-dose administration in Cycle 0
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 2 yearsPopulation: Study terminated, data not reported due to privacy reasons
Baseline ADA-positive participant is defined as a participant who has a 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 2 yearsPopulation: Study terminated, data not reported due to privacy reasons
ORR in participants with a best overall response (BOR) of complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for solid tumors
Outcome measures
Outcome data not reported
Adverse Events
BMS-986242 12.5 mg + Nivolumab 480 mg
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60