Status:
ACTIVE_NOT_RECRUITING
A Study of BMS-986253 in Combination With Nivolumab or Nivolumab Plus Ipilimumab in Advanced Cancers
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Cancer
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to investigate experimental medication BMS-986253 in combination with Nivolumab or Nivolumab plus Ipilimumab in participants with advanced cancers.
Eligibility Criteria
Inclusion
- Histologic or cytologic confirmation of a solid tumor that is advanced (metastatic, recurrent and/or unresectable) with measurable disease per RECIST v1.1
- At least 1 lesion accessible for biopsy
- Eastern Cooperative Oncology Group Performance Status of 0 or 1
Exclusion
- Participants with CNS metastases as the only site of active disease (Participants with controlled brain metastases; however, will be allowed to enroll)
- Participants with active, known or suspected autoimmune disease
- Participants with conditions requiring systemic treatment with either corticosteroids (\> 10mg prednisone equivalents) or other immunosuppressive medications within 14 days of study treatment administration
- Participants with a known history of testing positive for Human Immunodeficiency Virus (HIV) or known Acquired Immunodeficiency Syndrome (AIDS)
- Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study therapy
- Other protocol defined inclusion/exclusion criteria could apply
Key Trial Info
Start Date :
February 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2025
Estimated Enrollment :
281 Patients enrolled
Trial Details
Trial ID
NCT03400332
Start Date
February 12 2018
End Date
November 30 2025
Last Update
July 25 2025
Active Locations (72)
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1
Local Institution - 0059
Springdale, Arkansas, United States, 72762
2
Local Institution - 0099
Los Angeles, California, United States, 90033
3
Local Institution - 0007
Lakewood, Colorado, United States, 80228
4
Local Institution - 0087
Atlanta, Georgia, United States, 30322