A Phase 1, Bioavailability Study of Relatlimab in Combination With Nivolumab
- Registration Number
- NCT04112498
- Lead Sponsor
- Bristol-Myers Squibb
- 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 advanced tumors
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description nivolumab + relatlimab + rHuPH20 nivolumab - nivolumab + relatlimab + rHuPH20 rHuPH20 - nivolumab + relatlimab + rHuPH20 relatlimab -
- Primary Outcome Measures
Name Time Method maximum observed serum concentration (Cmax) approximately 60 days time of maximum observed serum concentration (Tmax) approximately 60 days area under the time-concentration curve over the dosing interval AUC (TAU) approximately 60 days Observed concentration at the end of the dosing interval (Ctau) approximately 60 days Incidence of Serious Adverse Events (SAEs) approximately 2 years Incidence of Adverse Events (AEs) approximately 2 years Incidence of Adverse Events leading to discontinuation approximately 2 years Number of deaths approximately 2 years Number of laboratory abnormalities approximately 2 years
- Secondary Outcome Measures
Name Time Method Incidence of Adverese Events (AEs) in the broad SMQ of Anaphylactic Reaction approximately 2 years Number of events within the hypersensitivity/infusion reaction select AE category approximately 2 years Incidence of anti-relatlimab antibodies and neutralizing antibodies (if applicable) approximately 2 years Incidence of anti-nivolumab antibodies and neutralizing antibodies (if applicable) approximately 2 years
Trial Locations
- Locations (1)
Local Institution - 0001
🇺🇸Hackensack, New Jersey, United States