A Phase 1, Bioavailability Study of Relatlimab in Combination With Nivolumab

Study Overview
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Brief Summary
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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

Official Title
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A Phase 1, Multi-Tumor, Bioavailability Study of Relatlimab in Combination With Nivolumab

Conditions
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Cancer

Intervention / Treatment
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* Drug: relatlimab
* Drug: nivolumab
* Drug: rHuPH20


Participation Criteria
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Eligibility Criteria
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nivolumab + relatlimab + rHuPH20<br> | Drug: relatlimab<br>* Specified dose on Specified days<br>Drug: nivolumab<br>* Specified dose on Specified days<br>* Other names: Opdivo;Drug: rHuPH20<br>* Specified dose on Specified days<br>* Other names: Enhanze;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |