A Phase 1/2 Study of BMS-986408 with and without Nivolumab or Nivolumab and Ipilimumab in Participants with Solid Tumors

Phase 1

• Conditions: Advanced Solid Tumours; MedDRA version: 21.0Level: LLTClassification code: 10049280Term: Solid tumour Class: 10029104; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2022-500823-61-00
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-15
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

Males or females = 18 years of age, Participants in Groups A and B must have a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy of any histology that is 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., Participants in Groups C, D and E must have a histologically or cytologically confirmed, advanced, unresectable/metastatic malignancy measurable by RECIST v1.1, with the following histologies: HNSCC, NSCLC, melanoma, or RCC, have previously received therapy containing anti-PD-(L)1 or anti-CTLA-4 agents, 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.

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, Women who are breastfeeding or are pregnant.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified