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

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

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

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Drug: relatlimab; Drug: nivolumab; Drug: rHuPH20

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Local Institution - 0001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: nivolumab + relatlimab + rHuPH20	Drug: relatlimab; Specified dose on Specified days; Drug: nivolumab; Specified dose on Specified days; Other Names: Opdivo; Drug: rHuPH20; Specified dose on Specified days; Other Names: Enhanze

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): February 27, 2023
• Study Completion (Actual): February 27, 2023

Study Registration Dates

• First Submitted: October 1, 2019
• First Submitted That Met QC Criteria: October 1, 2019
• First Posted (Actual): October 2, 2019

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: April 4, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Nivolumab
• Other Study ID Numbers: CA224-087

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No