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

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 1

Conditions

Cancer

Treatments

Drug: relatlimab

Drug: rHuPH20

Drug: nivolumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT04112498

CA224-087

Details and patient eligibility

About

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

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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