CompletedPhase 1

A Study of BMS-986416 With and Without Nivolumab in Select Solid Tumors

United States, Argentina, Belgium67 participantsStarted 2021-08-09

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participants with histologically or cytologically confirmed locally advanced unresectable, metastatic, or recurrent select solid tumor * Eligible tumor types Non-small cell lung cancer (NSCLC), Urothelial carcinoma (UC), Squamous cell carcinoma of the head and neck (SCCHN), Hepatocellular carcinoma (HCC), Microsatellite-stable colorectal carcinoma (MSS CRC), or Pancreatic ductal adenocarcinoma (PDAC) * Resistant/refractory to or intolerant of existing standard therapies known to provide clinical benefit * Measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1) * Disease amenable to serial biopsy Exclusion Criteria: * Uncontrolled or significant cardiovascular disease * Known connective tissue disease such as Marfan, Ehlers-Danlos, or Loeys-Dietz syndrome * Medical requirement for chronic anticoagulant or antiplatelet agents (except low-dose aspirin, which is permitted) Other protocol-defined inclusion/exclusion criteria apply

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Adverse Events (AEs)

Timeframe: Up to 100 days after the last treatment of study intervention(s)

Incidence of Serious Adverse Events (SAEs)

Timeframe: Up to 100 days after the last treatment of study intervention(s)

Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria

Timeframe: Up to 100 days after the last treatment of study intervention(s)

Incidence of AEs leading to discontinuation

Timeframe: Up to 100 days after the last treatment of study intervention(s)

Incidence of AEs leading to death

Timeframe: Up to 100 days after the last treatment of study intervention(s)

Protocol-defined maximum tolerated dose (MTD) or maximum administered dose (MAAD)

Timeframe: Up to 100 days after the last treatment of study intervention(s)

Trial details

NCT IDNCT04943900

SponsorBristol-Myers Squibb

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-02-27

View on ClinicalTrials.gov More Advanced Solid Tumors trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Incidence of Adverse Events (AEs)

Timeframe: Up to 100 days after the last treatment of study intervention(s)

Incidence of Serious Adverse Events (SAEs)

Timeframe: Up to 100 days after the last treatment of study intervention(s)

Incidence of AEs meeting protocol-defined dose-limiting toxicity (DLT) criteria

Timeframe: Up to 100 days after the last treatment of study intervention(s)

Incidence of AEs leading to discontinuation

Timeframe: Up to 100 days after the last treatment of study intervention(s)

Incidence of AEs leading to death

Timeframe: Up to 100 days after the last treatment of study intervention(s)

Protocol-defined maximum tolerated dose (MTD) or maximum administered dose (MAAD)

Timeframe: Up to 100 days after the last treatment of study intervention(s)