A Phase 1/2 Study of BMS-986449 with and without Nivolumab in Participants with Solid Tumors

Phase 1

Recruiting

• Conditions: Advanced, metastatic, solid malignancy; MedDRA version: 20.0Level: LLTClassification code: 10025648Term: Malignant mast cell tumors unspecified site extranodal and solid organ sites Class: 10029104; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: CTIS2023-503484-42-00
• Lead Sponsor: Bristol-Myers Squibb Services Unlimited Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-12
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

Participants =18 years of age with histologically or cytologically confirmed locally advanced unresectable, metastatic, or recurrent select solid tumor - Part 1A, participants may have a solid malignancy of any histology - Part1B is restricted to participants with NSCLC - Part 1C is restricted to participants with TNBC, Participants must have received, be refractory to, ineligible for, or intolerant of existing therapy(ies) known to provide clinical benefit for their condition., Participants must have measurable disease per RECIST v 1.1., Tumor biopsy must be obtained for all participants (unless medically precluded)

Exclusion Criteria

Participants with active, known or suspected autoimmune disease., Participants with a condition requiring systemic treatment with corticosteroids within 14 days or other immunosuppressive medications within 30 days of randomization, Participant with prior organ or tissue allograft, Participants with history of = Gr 3 toxicity related to prior T cell agonist or checkpoint inhibitor therapy (eg, anti-CTLA-4, or anti-PD-1/PD-L1 treatment, or any other antibody or drug specifically targeting T cell co-stimulation or other immune checkpoint pathways)., Participants with any significant acute or chronic medical illness which would interfere with study intervention or follow-up in the opinion of the investigator., Participants with untreated or symptomatic CNS metastases or leptomeningeal metastases.

Study & Design

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