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

NCT04112498 | Completed Phase 1 FDA Drug

• 1 other identifier: CA224-087
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Conditions

Cancer

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (4)

• 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

Study Arms (1)

nivolumab + relatlimab + rHuPH20

EXPERIMENTAL

Drug: relatlimab; Drug: nivolumab; Drug: rHuPH20

Interventions

relatlimab DRUG

Specified dose on Specified days

nivolumab + relatlimab + rHuPH20

nivolumab DRUG

Specified dose on Specified days

Also known as: Opdivo

nivolumab + relatlimab + rHuPH20

rHuPH20 DRUG

Specified dose on Specified days

Also known as: Enhanze

nivolumab + relatlimab + rHuPH20

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution - 0001

Hackensack, New Jersey, 07601, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Neoplasms

Interventions

relatlimab; Nivolumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: October 2, 2019
• Study Start: October 1, 2019
• Primary Completion: February 27, 2023
• Study Completion: February 27, 2023
• Last Updated: April 6, 2023

Record last verified: 2023-04

Locations

US (1)