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

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Active, not recruiting
Phase 2
Phase 1

Conditions

Advanced Cancer

Treatments

Biological: Nivolumab
Biological: BMS-986258
Drug: rHuPH20

Study type

Interventional

Funder types

Industry

Identifiers

NCT03446040
CA031-002
2019-000442-35 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

92 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

92 participants in 4 patient groups

Part A Dose Escalation: BMS-986258
Experimental group
Treatment:
Biological: BMS-986258
Part A1: BMS-986258 + Recombinant human hyaluronidase PH20 (rHuPH20)
Experimental group
Treatment:
Drug: rHuPH20
Biological: BMS-986258
Part B Dose Escalation: BMS-986258 + nivolumab
Experimental group
Treatment:
Biological: Nivolumab
Biological: BMS-986258
Part C Cohort Expansion: BMS-986258 + nivolumab
Experimental group
Treatment:
Biological: Nivolumab
Biological: BMS-986258

Trial contacts and locations

16

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Data sourced from clinicaltrials.gov

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