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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04112498
• Other study ID #: CA224-087
• Status: Completed
• Phase: Phase 1
• Start date: October 1, 2019
• Est. completion date: February 27, 2023

Study information

• Verified date: April 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 27, 2023
• Est. primary completion date: February 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• relatlimab
Specified dose on Specified days
• nivolumab
Specified dose on Specified days
• rHuPH20
Specified dose on Specified days

Locations

Country	Name	City	State
United States	Local Institution - 0001	Hackensack	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maximum observed serum concentration (Cmax)		approximately 60 days
Primary	time of maximum observed serum concentration (Tmax)		approximately 60 days
Primary	area under the time-concentration curve over the dosing interval AUC (TAU)		approximately 60 days
Primary	Observed concentration at the end of the dosing interval (Ctau)		approximately 60 days
Primary	Incidence of Serious Adverse Events (SAEs)		approximately 2 years
Primary	Incidence of Adverse Events (AEs)		approximately 2 years
Primary	Incidence of Adverse Events leading to discontinuation		approximately 2 years
Primary	Number of deaths		approximately 2 years
Primary	Number of laboratory abnormalities		approximately 2 years
Secondary	Incidence of Adverese Events (AEs) in the broad SMQ of Anaphylactic Reaction		approximately 2 years
Secondary	Number of events within the hypersensitivity/infusion reaction select AE category		approximately 2 years
Secondary	Incidence of anti-relatlimab antibodies and neutralizing antibodies (if applicable)		approximately 2 years
Secondary	Incidence of anti-nivolumab antibodies and neutralizing antibodies (if applicable)		approximately 2 years

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting