Status:
TERMINATED
An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are Advanced or Have Spread
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Advanced Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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.
Eligibility Criteria
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
Key Trial Info
Start Date :
March 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 29 2024
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT03446040
Start Date
March 8 2018
End Date
August 29 2024
Last Update
September 18 2025
Active Locations (16)
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1
Local Institution - 0004
Los Angeles, California, United States, 90033
2
Local Institution - 0006
Los Angeles, California, United States, 90033
3
Local Institution - 0007
Aurora, Colorado, United States, 80045
4
University Of Iowa Hospitals And Clinics
Iowa City, Iowa, United States, 52242