A Study of BMS-986449 With and Without Nivolumab in Participants With Advanced Solid Tumors

Bristol-Myers Squibb (BMS)

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: BMS-986449; Drug: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05888831

U1111-1287-3575 (Registry Identifier)

2023-503484-42 (EudraCT Number)

CA120-1001

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of BMS-986449 alone and in combination with nivolumab in participants with advanced solid tumors.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All participants must have a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy (measurable by Response Evaluation Criteria in Solid Tumors [RECIST] v1.1), and have received, be refractory to, ineligible for, or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant.

  • Part 1A may have a solid malignancy of any histology.
  • Part 1B is restricted to participants with Non-small cell lung cancer (NSCLC).
  • Part 1C is restricted to participants with Triple-negative breast cancer (TNBC).

• Tumor biopsy must be obtained for all participants (unless medically precluded).

Exclusion criteria

• History of Grade ≥ 3 toxicity related to prior T-cell agonist or checkpoint inhibitor therapy (eg, anti-cytotoxic T-lymphocyte-associated antigen 4 [CTLA-4], or anti-PD- 1/programmed death-ligand 1 [PD-L1] treatment, or any other antibody or drug specifically targeting T-cell co-stimulation or other immune checkpoint pathways) except those that are unlikely to re-occur with standard countermeasures.
• Current or recent (within 3 months of study intervention administration) gastrointestinal disease or gastrointestinal surgery (eg, intestinal/gastric/colon resection) that could impact the absorption of study intervention.
• Any significant acute or chronic medical illness which would interfere with study intervention or follow-up in the opinion of the investigator.

Other protocol-defined criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

Dose Escalation: BMS-986449 monotherapy

Experimental group

Treatment:

Drug: BMS-986449

Dose Escalation: BMS-986449 + nivolumab

Experimental group

Treatment:

Drug: Nivolumab

Drug: BMS-986449

Dose Escalation: BMS-986449 monotherapy pharmacodynamic (PD) cohorts

Experimental group

Treatment:

Drug: BMS-986449