CompletedPhase 1

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

United States67 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 range18 Years

SexALL

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

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 range18 Years

SexALL

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)