Status:
COMPLETED
A Phase 1, Bioavailability Study of Relatlimab in Combination With Nivolumab
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study will characterize the movement of drugs within the body, evaluate safety and determine to which extent the body can process relatlimab in combination with nivolumab in subjects with certain...
Eligibility Criteria
Inclusion
- For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
- Histologic or cytologic confirmation of (unresectable and/or metastatic) advanced solid tumors
- Melanoma
- Metastatic squamous or non- squamous non-small cell lung cancer (NSCLC)
- Gastric adenocarcinoma (includes gastro-esophageal junction)
- Hepatocellular carcinoma (HCC)
- Squamous cell carcinoma of the head and neck (SCCHN)
- Renal cell carcinoma (RCC)
- Bladder cancer
- Participants must have received available standard therapies
- Women and men must agree to follow instructions for method of contraception
- Measureable disease as per RECIST version 1.1 criteria
- Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion
- Participants must not have active brain metastases or leptomeningeal metastases
- Participants with HCC must not have any history of hepatic encephalopathy, any prior (within 1 year) or current clinically significant ascites
- History of allergy or hypersensitivity to study drug components
- Participants with serious or uncontrolled cardiovascular disease
- Excluding patients with serious or uncontrolled medical disorders
- Participants with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of start of study treatment
- Participants with an active, known, or suspected autoimmune disease
- Participants must not have evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population
- Other protocol defined inclusion/exclusion Criteria could apply
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04112498
Start Date
October 1 2019
End Date
February 27 2023
Last Update
April 6 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Local Institution - 0001
Hackensack, New Jersey, United States, 07601