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Active, Not Recruiting

A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers - CA027-002

Updated: 15 July, 2024   |   ClinicalTrials.gov

Print Friendly Summary

CONSIDERING THIS TRIAL?
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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

    Phase

  • Gender(s)

  • 18+

    Age Range

  • Active, Not Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Part 1A: BMS-986253 + nivolumab
Drug: BMS-986253 Biological: Nivolumab
Experimental: Part 1B: BMS-986253 + nivolumab
Drug: BMS-986253 Biological: Nivolumab
Experimental: Part 1C: BMS-986253 + nivolumab + ipilimumab
Drug: BMS-986253 Biological: Nivolumab, Ipilimumab
Experimental: Part 2A: BMS-986253 + nivolumab + ipilimumab
Drug: BMS-986253 Biological: Nivolumab, Ipilimumab
Placebo Comparator: Part 2B: Placebo + nivolumab + ipilimumab
Biological: Nivolumab, Ipilimumab Other: Placebo

Key Eligibility Criteria

Inclusion Criteria: - Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1 - At least 1 lesion accessible for biopsy - Eastern Cooperative Oncology Group Performance Status of 0 or 1 Exclusion Criteria: - Participants with CNS metastases as the only site of active disease (Participants with controlled brain metastases; however, will be allowed to enroll) - Participants with active, known or suspected autoimmune disease - Participants with conditions requiring systemic treatment with either corticosteroids (> 10mg prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration - Participants with a known history of testing positive for Human Immunodeficiency Virus (HIV) or known Acquired Immunodeficiency Syndrome (AIDS) - Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy Other protocol defined inclusion/exclusion criteria could apply

If you want to report a side effect, you can report directly to the Danish Medicines Agency via the website www.meldenbivirkning.dk
We recommend that you also contact BMS to report side effects.
Side effects and other reportable events are defined here
Report side effects or product quality complaints: Medical Information

466-DK-2200001