Status:
TERMINATED
An Investigational Immuno-Therapy Study of Experimental Medication BMS-986242 Given in Combination With Nivolumab in Patients With Advanced Cancer
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 safety of experimental medication BMS-986242 and Nivolumab in patients with advanced cancers.
Eligibility Criteria
Inclusion
- For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
- Histologic or cytological confirmation of a malignancy that is advanced (metastatic and/or unresectable) with measureable disease per RECIST v1.1
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Ability to swallow tablets
- Adequate bone marrow and organ function, as defined by the protocol
Exclusion
- Participants with known or suspected CNS metastases, untreated CNS metastases, or with the CNS as the only site of disease (patients with controlled brain metastasis allowed to enroll)
- Ocular melanoma
- Any significant acute or chronic medical illness
- Prior malignancy
- Other active malignancy requiring concurrent intervention
- Prior organ allograft or allogeneic bone marrow transplantation
- Participants with active, known, or suspected autoimmune disease
- Requirement for daily supplemental oxygen
- Uncontrolled or significant cardiovascular disease
- Pre-existing liver disease
- Gastrointestinal disease known to interfere with absorption
- Other protocol defined inclusion/exclusion criteria could apply
Key Trial Info
Start Date :
November 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 28 2018
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT03351231
Start Date
November 27 2017
End Date
August 28 2018
Last Update
August 26 2020
Active Locations (4)
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1
University Of Alabama At Birmingham
Birmingham, Alabama, United States, 35294-3300
2
Hoag Memorial Hospital Presbyterian
Los Angeles, California, United States, 90033
3
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
4
Local Institution
Baltimore, Maryland, United States, 21287