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An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are Advanced or Have Spread - CA031-002

Updated: 22 December, 2020   |   ClinicalTrials.gov

Print Friendly Summary

Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 1/Phase 2


  • Gender(s)

  • 18+

    Age Range

  • 16


  • Recruiting

Treatment Options

Study Arms
Experimental: Part A Dose Escalation: BMS-986258
Biological: BMS-986258
Experimental: Part A1: BMS-986258 + Recombinant human hyaluronidase PH20 (rHuPH20)
Biological: BMS-986258 Drug: rHuPH20
Experimental: Part B Dose Escalation: BMS-986258 + nivolumab
Biological: Nivolumab Biological: BMS-986258
Experimental: Part C Cohort Expansion: BMS-986258 + nivolumab
Biological: Nivolumab Biological: BMS-986258

Key Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Histologic confirmation of one of the 5 tumors [renal cell carcinoma (RCC), colorectal cancer (CRC), non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), triple negative breast cancer (TNBC)] (metastatic, recurrent, and/or unresectable), with measurable disease per response evaluation criteria in solid tumors v1.1 (RECIST v1.1) and have at least one lesion accessible for biopsy - Eastern Cooperative Oncology Group Performance Status of 0 or 1 - Participants must have received, and then progressed, relapsed, or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting according to solid tumor histologies - Women and men must agree to follow specific methods of contraception, if applicable Exclusion Criteria: - Active, known or suspected autoimmune disease - Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy - Other active malignancy requiring concurrent intervention Other protocol-defined inclusion/exclusion criteria apply

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

Have questions? Live support is available 24/7 - Call 855-907-3286 or email clinical.trials@bms.com

Have questions? Live support is available 24/7 -
Call 855-907-3286 or email clinical.trials@bms.com