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CompletedLast updated: 11 April 2024

TIM-3: This phase I/II trial is testing how safe and tolerable an immunotherapy is when given by itself or in combination with another standard type of immunotherapy (Nivolumab) in patients with advanced cancerA Phase 1/2 First-in-Human Study of BMS-986258 Alone and in Combination With Nivolumab in Advanced Malignant Tumors

Clinical summary

Summary

Eligible patients will receive a specified dose of BMS-986258 on a specified day, either alone or in combination with Nivolumab.

Conditions

This trial is treating patients with advanced cancer.

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I/II

Trial Acronym

TIM-3

More information

Trial Identifiers

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Trial sponsor

Bristol-Myers Squibb (BMS)

Scientific Title

A Phase 1/2 First-in-Human Study of BMS-986258 Alone and in Combination With Nivolumab in Advanced Malignant Tumors

Eligibility

Inclusion

  • 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)
  • 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 must agree to follow specific methods of contraception, if applicable

Exclusion

  • 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

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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

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Completed hospitals

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Victorian Cancer Registry Victorian Government

The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

RAP

Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.