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 — DRUG
    Specified dose on specified days
  • Nivolumab — BIOLOGICAL
    Specified dose on specified days
  • Oxaliplatin — DRUG
    Specified dose on specified days
  • Capecitabine — DRUG
    Specified dose on specified days
  • Fluorouracil — DRUG
    Specified dose on specified days
  • Calcium folinate — DRUG
    Specified 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)

FacilityCityStateZIPSite coordinators
Local Institution - 0003TucsonArizona85719-
Local Institution - 0007Los AngelesCalifornia90033-
Local Institution - 0011Grand RapidsMichigan49546-
Local Institution - 0004Sioux FallsSouth Dakota57104-
Local Institution - 0013San AntonioTexas78229-

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