A Phase 1 interventional study of BMS-986416 and Nivolumab in Advanced Solid Tumors, sponsored by Bristol-Myers Squibb. Completed at 19 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-09.
Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Treatment
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 67 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
Drug: BMS-986416
Drug: BMS-986416 · Drug: Nivolumab
Specified dose on specified days
Specified dose on specified days
Also known as: BMS-936558, Opdivo
Incidence of Adverse Events (AEs)
Time frame: Up to 100 days after the last treatment of study intervention(s)
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 100 days after the last treatment of study intervention(s)
Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria
Time frame: Up to 100 days after the last treatment of study intervention(s)
Incidence of AEs leading to discontinuation
Time frame: Up to 100 days after the last treatment of study intervention(s)
Incidence of AEs leading to death
Time frame: Up to 100 days after the last treatment of study intervention(s)
Protocol-defined maximum tolerated dose (MTD) or maximum administered dose (MAAD)
Time frame: Up to 100 days after the last treatment of study intervention(s)
Maximum observed serum concentration (Cmax) of BMS-986416
Time frame: Up to 100 days after the last treatment of study intervention(s)
Time of maximum observed serum concentration (Tmax) of BMS-986416
Time frame: Up to 100 days after the last treatment of study intervention(s)
Trough observed serum concentration (Ctrough) of BMS-986416
Time frame: 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
Time frame: Up to 2 years
Duration of Response (DOR) using RECIST 1.1 per Investigator assessment
Time frame: 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
Time frame: Up to 100 days after the last treatment of study intervention(s)
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Bristol-Myers Squibb