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2021-08-09
2025-02-27
2025-02-27
67
NCT04943900
Bristol-Myers Squibb
Bristol-Myers Squibb
INTERVENTIONAL
A Study of BMS-986416 With and Without Nivolumab in Select Solid Tumors
The purpose of this study is to evaluate the safety, tolerability, drug effects, drug levels and preliminary antitumor activity of BMS-986416 when administered alone and in combination with Nivolumab in participants with select advanced solid tumors.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2021-06-25 | N/A | 2025-04-07 |
2021-06-25 | N/A | 2025-04-09 |
2021-06-29 | N/A | 2025-04 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Non Randomized
Interventional Model:
Sequential
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Part 1A: Monotherapy (BMS-986416) | DRUG: BMS-986416
|
| EXPERIMENTAL: Part 1B: Combination Therapy (BMS-986416 + Nivolumab) | DRUG: BMS-986416
DRUG: Nivolumab
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs) | Up to 100 days after the last treatment of study intervention(s) | |
| Incidence of Serious Adverse Events (SAEs) | Up to 100 days after the last treatment of study intervention(s) | |
| Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria | Up to 100 days after the last treatment of study intervention(s) | |
| Incidence of AEs leading to discontinuation | Up to 100 days after the last treatment of study intervention(s) | |
| Incidence of AEs leading to death | Up to 100 days after the last treatment of study intervention(s) | |
| Protocol-defined maximum tolerated dose (MTD) or maximum administered dose (MAAD) | Up to 100 days after the last treatment of study intervention(s) |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Maximum observed serum concentration (Cmax) of BMS-986416 | Up to 100 days after the last treatment of study intervention(s) | |
| Time of maximum observed serum concentration (Tmax) of BMS-986416 | Up to 100 days after the last treatment of study intervention(s) | |
| Trough observed serum concentration (Ctrough) of BMS-986416 | Up to 100 days after the last treatment of study intervention(s) | |
| Overall Response Rate (ORR) using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) per Investigator assessment | Up to 2 years | |
| Duration of Response (DOR) using RECIST 1.1 per Investigator assessment | Up to 2 years | |
| Incidence of clinically significant changes in ECG parameters: QTcF | QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave | Up to 100 days after the last treatment of study intervention(s) |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
