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RecruitingLast updated: 4 March 2024

This phase I/II study is investigating the effects of targeted therapy (BMS-986253) in combination with immunotherapy (nivolumab and/or ipilimumab) in people with advanced solid cancersA Phase 1/2 Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers

Clinical summary

Summary

This study has 5 experimental arms across two phases. In Parts 1A and 1B, participants will receive BMS-986253 and nivolumab. In Part 1C, participants will receive BMS-986253 in combination with nivolumab and ipilimumab. In Part 2A, participants will receive BMS-986253 in combination with nivolumab and ipilimumab. In Part 2B, participants will receive a placebo in combination with nivolumab and ipilimumab.

Conditions

This trial is treating patients with solid cancers.

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I/II

More information

Trial Identifiers

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Trial sponsor

Bristol-Myers Squibb (BMS)

Scientific Title

A Phase 1/2 Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers

Eligibility

Inclusion

  • 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

  • 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

Inclusion

  • You have had treatment, but your cancer has come back.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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