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No longer recruiting (closed or complete)Last updated: 11 April 2024

This phase I/II trial is trying to determine whether it is safe to give the study drug (BMS-986249), alone and in combination with an immunotherapy (Nivolumab), to patients with advanced solid cancersA Phase 1/2 First-in-Human Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid Tumors

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Clinical summary

Summary

This is a non-randomised trial. Patients will receive specified doses of BMS-986249 with or without Nivolumab on specified days.

Conditions

This trial is treating people with advanced solid cancers

Eligibility

Inclusion

  • Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent, and/or unresectable) with measurable disease or metastatic disease documented by either bone lesions on radionuclide bone scan and/or soft tissue lesions on CT/MRI for prostate cancer and have at least 1 lesion accessible for biopsy. For Part 2B participants with HCC, intermediate disease is allowed.
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1
  • 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 tumor type, if such a therapy exists
  • Prior anti-cancer treatments such as chemotherapy, radiotherapy, or hormonal are permitted for some participants
  • Willing and able to comply with all study procedures

Exclusion

  • Primary central nervous system (CNS) malignancies, tumors with CNS metastases as the only site of disease or active brain metastases will be excluded
  • Other active malignancy requiring concurrent intervention
  • Prior organ allograft
  • Active, known, or suspected autoimmune disease

Other protocol-defined inclusion/exclusion criteria apply

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
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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No longer recruiting (closed or complete) 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 First-in-Human Study of BMS-986249 Alone and in Combination With Nivolumab in Advanced Solid Tumors

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