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Trial ID CA031-002  |   NCT03446040

An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are Advanced or Have Spread

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Summary

  • Phase 1/Phase 2
  • Male and Female Gender icon
  • 18+
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

The purpose of this study is to determine whether BMS-986258 both monotherapy and in combination with Nivolumab is safe and tolerable in the treatment of advanced malignant tumors.

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Key Eligibility Criteria

Inclusion Criteria: - 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 Criteria: - 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

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: Part A Dose Escalation: BMS-986258

ASSIGNED INTERVENTION
  • Biological: BMS-986258

Study Arms

Experimental: Part A1: BMS-986258 + Recombinant human hyaluronidase PH20 (rHuPH20)

ASSIGNED INTERVENTION
  • Biological: BMS-986258
  • Drug: rHuPH20

Study Arms

Experimental: Part B Dose Escalation: BMS-986258 + nivolumab

ASSIGNED INTERVENTION
  • Biological: BMS-986258, Nivolumab

Study Arms

Experimental: Part C Cohort Expansion: BMS-986258 + nivolumab

ASSIGNED INTERVENTION
  • Biological: BMS-986258, Nivolumab

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