A Study of BMS-986484 Alone and Combination Therapy in Participants With Advanced Solid Tumors
Part of paid clinical trials in Tucson, Arizona.
- Sponsor
- Bristol-Myers Squibb
- Study ID
- NCT06544655
- Phase
- PHASE1
- Status
- Active Not Recruiting
Conditions
- Advanced Solid Tumors
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- BMS-986484 — DRUGSpecified dose on specified days
- Nivolumab — BIOLOGICALSpecified dose on specified days
- Oxaliplatin — DRUGSpecified dose on specified days
- Capecitabine — DRUGSpecified dose on specified days
- Fluorouracil — DRUGSpecified dose on specified days
- Calcium folinate — DRUGSpecified dose on specified days
Study Details
The purpose of this study is to assess the safety and tolerability of BMS-986484 administered alone, in combination with nivolumab in participants with advanced/metastatic solid tumors including non-small cell lung cancer (NSCLC), microsatellite stable (MSS) colorectal carcinoma (CRC), pancreatic ductal adenocarcinoma (PDAC), gastric/gastroesophageal junction adenocarcinoma (G/GEJC), and squamous cell carcinoma of the head and neck (SCCHN).
Key Dates
- Start date
- Oct 10, 2024
- Status verified
- Apr 2026
- Primary completion
- Oct 14, 2027
- Completion
- Oct 14, 2027
Study Design
- Enrollment
- 213 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: Part 1A: BMS-986484 Dose Escalation
- Experimental: Part 1B: BMS-986484 + Nivolumab Dose Escalation
- Experimental: Part 2A: BMS-986484 Dose Expansion
- Experimental: Part 2B: BMS-986484 + Nivolumab Dose Expansion
- Experimental: Part 1C: BMS-986484 + Nivolumab + Chemotherapy Dose Escalation
- Experimental: Part 1 Co-Admin: BMS-986484 + Nivolumab
- Experimental: Part 1SC: BMS-986484 Monotherapy Subcutaneous Dose Escalation
- Experimental: Part 2C: BMS-986484 + Nivolumab + Chemotherapy Dose Expansion
Primary Outcome Measure
Incidence of adverse events (AEs) [ Time Frame: Up to approximately 2 years ]
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Local Institution - 0003 | Tucson | Arizona | 85719 | - |
| Local Institution - 0007 | Los Angeles | California | 90033 | - |
| Local Institution - 0011 | Grand Rapids | Michigan | 49546 | - |
| Local Institution - 0004 | Sioux Falls | South Dakota | 57104 | - |
| Local Institution - 0013 | San Antonio | Texas | 78229 | - |
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