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No longer recruiting (closed or complete)Last updated: 17 September 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

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 people with solid 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 (relapsed or recurrent).
  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
  • Your cancer has not spread to other parts of the body (localised).
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

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

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