A Study of BMS-986482 Alone or as Combination Therapy in Participants With Advanced Solid Tumors

Bristol-Myers Squibb (BMS)

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Drug: Nivolumab/relatlimab/rHuPH20; Drug: BMS-986482; Drug: Nivolumab and rHuPH20; Drug: Bevacizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06697197

U1111-1309-0886 (Other Identifier)

2024-516602-28 (Other Identifier)

CA236-0001

Details and patient eligibility

About

The purpose of this study is to test the safety and efficacy of BMS-986482 alone and as combination therapy in participants with advanced solid tumors.

Enrollment: 413 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 RECIST v1.1, and have received, be refractory to, ineligible for, intolerant of, or refused existing therapy(ies) known to provide clinical benefit for the condition of the participant.
• Participant must be ≥ 18 years or the legal age of consent in the jurisdiction in which the study is taking place, inclusive, at the time of signing the ICF.
• Participants in Part 1A may have NSCLC, SCCHN, MSS-CRC, gastric/GEJ adenocarcinoma, urothelial carcinoma, PDAC, melanoma or breast cancer (TNBC and ER+HER2-).
• Participants in Part 1B1 and 2B1 must have NSCLC and, if known, should have documented status for EGFR, KRAS, ALK, ROS1, RET, NTRK, MET exon 14 skipping mutations, and BRAF V600E.Participants must have received platinum-based chemotherapy and anti-PD-(L)1 therapy, if eligible and available.
• Participants in Parts 1B2, 2B2, and 1C must have cutaneous, acral, mucosal, or unknown primary melanoma. Participants with uveal/ocular melanoma are excluded. Participants must be melanoma 2L+.
• Participants in Part 1B3 must have advanced or metastatic MSS-CRC.
• Participants in Part 2A may have advanced solid tumors (advanced, unresectable, or metastatic NSCLC, advanced, unresectable, hormone resistant ER+HER2-breast cancer or pancreatic adenocarcinoma [PDAC]) based on emerging data.
• Participants in Part 2B3 must have advanced or metastatic MSS-CRC.
• For all participants in Part 1C cohort, a tumor sample from a ("fresh") biopsy [core biopsy (at least 4 passages recommended), punch biopsy, excisional biopsy or surgical specimen] must be obtained (obtained within 1 month of the start of the Screening, if there are tumor sites that can be biopsied with acceptable clinical risk).

Exclusion criteria

• History of life threatening immune mediated toxicity related to prior T-cell agonist or checkpoint inhibitor therapy, except those that are unlikely to re-occur with standard countermeasures.
• 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 Inclusion/Exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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413 participants in 9 patient groups

Part 1A

Experimental group

Treatment:

Drug: BMS-986482

Part 1B1

Experimental group

Treatment:

Drug: Nivolumab and rHuPH20

Drug: BMS-986482

Part 1B2

Experimental group

Treatment:

Drug: BMS-986482

Drug: Nivolumab/relatlimab/rHuPH20

Part 1B3

Experimental group

Treatment:

Drug: Bevacizumab

Drug: BMS-986482

Part 1C

Experimental group

Treatment:

Drug: BMS-986482

Part 2A

Experimental group

Treatment:

Drug: BMS-986482

Part 2B1

Experimental group

Treatment:

Drug: Nivolumab and rHuPH20

Drug: BMS-986482

Part 2B2

Experimental group

Treatment:

Drug: BMS-986482

Drug: Nivolumab/relatlimab/rHuPH20

Part 2B3

Experimental group

Treatment:

Drug: Bevacizumab

Drug: BMS-986482