NCT04943900CompletedPhase 1
A Study of BMS-986416 With and Without Nivolumab in Select Solid Tumors
A Phase 1 Study of BMS-986416 Alone and in Combination With Nivolumab in Select Solid Tumors
Source: ClinicalTrials.gov · Last updated 9 Apr 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 67 (actual)
- First submitted
- 25 Jun 2021
- Start date
- 9 Aug 2021
- Primary completion date
- 27 Feb 2025
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Head and neck cancer, Bladder cancer, Lung cancer, Pancreatic cancer, Colorectal cancer, Liver and biliary tract cancer
- NCT number
- NCT04943900
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 67
- From 9 Aug 2021 to the primary completion date, 27 Feb 2025
- 19 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Uncontrolled or significant cardiovascular disease
- Known connective tissue disease such as Marfan, Ehlers-Danlos, or Loeys-Dietz syndrome
Other
- Medical requirement for chronic anticoagulant or antiplatelet agents (except low-dose aspirin, which is permitted)
- Other protocol-defined inclusion/exclusion criteria apply
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (19)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.