Share Icon Health Study Area: Cardiovascular Disease Chevron Icon Health Study Area: Genitourinary For Patients Health Study Area: Lung Cancer Page Icon Phone Icon For Caregivers Health Study Area: AutoImmune Disease Health Study Area: Melanoma Location Icon Print YouTube Icon For Parents Health Study Area: Lung Cancer Print Created with Sketch. Help Icon Green Check Icon Search Icon Instagram Created with sketchtool. Direction Arrow Icon Error Icon For Parents Health Study Area: Blood Cancer Help Icon Health Study Area: NASH Gender Both Bookmark Icon Health Study Area: Melanoma Created with Sketch. Glossary Print Health Study Area: Blood Cancer Health Study Area: Genitourinary Health Study Area: Gastrointestinal Cancer Mobile Menu Icon Created with Sketch. Health Study Area: Cardiovascular Disease Health Study Area: Women's Cancer Communities Map Icon Created with Sketch. For Caregivers Health Study Area: Fibrosis Health Study Area: AutoImmune Disease FAQs Health Study Area: Head and Neck Cancer Created with Sketch. For Clinicians Chevron Right Icon Gender Female Health Study Area: Breast Cancer Direction Arrow Icon Gender Both Right Arrow Icon LinkedIn Icon Green Check Icon Gender Male Health Study Area: Fibrosis For Patients Twitter Icon Email Icon Facebook Icon Health Study Area: Gastrointestinal Cancer Health Study Area: Head and Neck Cancer For Clinicians External Link Icon

Menu

Search BMS Clinical Trials
BMS Active Not Yet Recruiting Study icon

Active, Not Recruiting

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

Warning icon
Sorry, this study is no longer accepting new participants, but is still ongoing.
You may click the “Check Your Eligibility” button and answer a few questions about your health to find out if you might be a match to another study.
Check Your Eligibility

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.

print Print
email Email

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
  • Drug: rHuPH20
  • Biological: BMS-986258

Study Arms

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

ASSIGNED INTERVENTION
  • Biological: Nivolumab, BMS-986258

Study Arms

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

ASSIGNED INTERVENTION
  • Biological: BMS-986258, Nivolumab