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

Program Status

Active, not recruiting

Phase

Phase 1

Prior Immunotherapy Allowed

Yes

CRC-directed Trial

No

Drugs

BMS-986258, Nivolumab, rHuPH20

Tags

MSS/ MMRp

Comments

BMS-986258 (TIM-3 antibody) + nivolumab (anti PD-1)

Location Location Status
United States
Local Institution - 0004
Los Angeles, California 90033
Active, not recruiting
Local Institution - 0006
Los Angeles, California 90033
Active, not recruiting
Local Institution - 0007
Aurora, Colorado 80045
Active, not recruiting
University Of Iowa Hospitals And Clinics
Iowa City, Iowa 52242
Active, not recruiting
Local Institution - 0018
Ann Arbor, Michigan 48109-5912
Active, not recruiting
Local Institution - 0010
Grand Rapids, Michigan 49546
Active, not recruiting
Local Institution - 0012
Lebanon, New Hampshire 03756
Active, not recruiting
Local Institution - 0016
Cincinnati, Ohio 45267
Active, not recruiting
Local Institution - 0005
Pittsburgh, Pennsylvania 15232
Active, not recruiting
Local Institution - 0002
Germantown, Tennessee 38138
Active, not recruiting
Australia
Local Institution - 0013
Westmead, New South Wales 2145
Active, not recruiting
Local Institution - 0015
Melbourne, Victoria 3084
Active, not recruiting
Canada
Local Institution - 0014
Edmonton, Alberta T6X 1E8
Active, not recruiting
Local Institution - 0019
Vancouver, British Columbia V5Z 4E6
Active, not recruiting
Japan
Local Institution - 0009
Kobe-shi, Hyogo 6500017
Active, not recruiting
Local Institution - 0008
Chuo-ku, Tokyo 1040045
Active, not recruiting

Inclusion 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

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

NCT ID

NCT03446040

Date Trial Added

2018-02-26

Updated Date

2024-04-03