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A Study to Evaluate the Safety and Tolerability of BMS-986408 Alone and in Combination With Nivolumab or Nivolumab and Ipilimumab in Participants With Advanced Solid Tumors

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Active, not recruiting
Phase 2
Phase 1

Conditions

Advanced Solid Tumors

Treatments

Biological: Platinum-doublet chemotherapy
Biological: Nivolumab
Drug: Rabeprazole
Biological: Ipilimumab
Drug: BMS-986408

Study type

Interventional

Funder types

Industry

Identifiers

NCT05407675
CA099-003

Details and patient eligibility

About

The primary purpose of this study is to characterize the safety profile of BMS-986408 as monotherapy and in combination with nivolumab or nivolumab and ipilimumab to establish the maximum tolerated dose (MTD). The Recommended Phase 2 Dose (RP2D) that optimizes the pharmacokinetic/pharmacodynamic (PK/PD) relationship of BMS-986408 will also be determined.

Enrollment

402 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Participants with a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy of any histology measurable by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  • Participants who have received, been refractory to, ineligible for, or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant
  • Participants with melanoma should have documentation of mutation status for B-type Raf proto-oncogene (BRAF) and neuroblastoma ras viral oncogene homolog (NRAS)
  • Participants must have experienced radiographically documented progressive disease on or after the most recent therapy

Exclusion criteria

  • An active, known or suspected autoimmune disease
  • Conditions requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment
  • Current or recent gastrointestinal disease or gastrointestinal surgery that could impact the absorption of study drug
  • Untreated central nervous system (CNS) metastases or leptomeningeal metastasis

Other protocol-defined inclusion/exclusion criteria apply

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

402 participants in 7 patient groups

Part 1: BMS-986408 Monotherapy
Experimental group
Treatment:
Drug: BMS-986408
Part 2: BMS-986408 in combination with nivolumab
Experimental group
Treatment:
Drug: BMS-986408
Biological: Nivolumab
Part 2: BMS-986408 in combination with nivolumab and ipilimumab
Experimental group
Treatment:
Drug: BMS-986408
Biological: Nivolumab
Biological: Ipilimumab
Part 2: BMS-986408 in combination with nivolumab and chemotherapy
Experimental group
Treatment:
Drug: BMS-986408
Biological: Nivolumab
Biological: Platinum-doublet chemotherapy
Part 2: BMS-986408 in combination with rabeprazole
Experimental group
Treatment:
Drug: BMS-986408
Drug: Rabeprazole
Part 3: BMS-986408 in combination with nivolumab
Experimental group
Treatment:
Drug: BMS-986408
Biological: Nivolumab
Part 3: BMS-986408 in combination with nivolumab and chemotherapy
Experimental group
Treatment:
Drug: BMS-986408
Biological: Nivolumab
Biological: Platinum-doublet chemotherapy

Trial contacts and locations

19

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Central trial contact

BMS Study Connect Contact Center http://www.bmsstudyconnect.com; First line of the email MUST contain NCT # and Site #.

Data sourced from clinicaltrials.gov

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