Status:
TERMINATED
An Investigational Immuno-Therapy Study of Experimental Medication BMS-986277 Given Alone and in Combination With Nivolumab in Epithelial Cancers
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to investigate experimental medication BMS-986277 given alone and in combination with Nivolumab in patients with epithelial cancers.
Eligibility Criteria
Inclusion
- For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
- Histological or cytological confirmation of metastatic and/or unresectable metastatic colorectal, prostate, pancreatic, breast, ovarian, or urothelial carcinoma with measureable disease for solid tumors per RECIST v1.1 and for prostate carcinoma per PCWG3
- Presence of at least 2 lesions: at least one with measurable disease as defined by RECIST v1.1 for solid tumors and by PCWG3 for prostate carcinoma for response assessment; at least 1 lesion must be accessible for biopsy in addition to the target lesion
- Participants must have received, and then progressed or been intolerant to, at least 1 standard treatment regimen in the advanced or metastatic setting, if such a therapy exists, and have been considered for all other potentially efficacious therapies prior to enrollment
- ECOG performance status less than or equal to 2
Exclusion
- Participants with active central nervous system (CNS) metastases, untreated CNS metastases, or with the CNS as the only site of disease
- Participants with carcinomatous meningitis
- Cytotoxic agents, unless at least 4 weeks have elapsed from last dose of prior anti-cancer therapy and initiation of study treatment
- Participants with active, known, or suspected autoimmune disease
- Other protocol defined inclusion/exclusion criteria could apply
Key Trial Info
Start Date :
December 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 22 2019
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03363776
Start Date
December 6 2017
End Date
November 22 2019
Last Update
December 19 2020
Active Locations (3)
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1
Sanford Research
Sioux Falls, South Dakota, United States, 57104
2
Local Institution
Ottawa, Ontario, Canada, K1H 8L6
3
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 1Z5