Clinical Trials /

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

NCT04112498

Description:

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

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: CA224-087
  • NCT ID: NCT04112498

Conditions

  • Cancer

Interventions

DrugSynonymsArms
relatlimabnivolumab + relatlimab + rHuPH20
nivolumabOpdivonivolumab + relatlimab + rHuPH20
rHuPH20Enhanzenivolumab + relatlimab + rHuPH20

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
nivolumab + relatlimab + rHuPH20Experimental
  • relatlimab
  • nivolumab
  • rHuPH20

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:maximum observed serum concentration (Cmax)
Time Frame:approximately 60 days
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Incidence of Adverese Events (AEs) in the broad SMQ of Anaphylactic Reaction
Time Frame:approximately 2 years
Safety Issue:
Description:
Measure:Number of events within the hypersensitivity/infusion reaction select AE category
Time Frame:approximately 2 years
Safety Issue:
Description:
Measure:Incidence of anti-relatlimab antibodies and neutralizing antibodies (if applicable)
Time Frame:approximately 2 years
Safety Issue:
Description:
Measure:Incidence of anti-nivolumab antibodies and neutralizing antibodies (if applicable)
Time Frame:approximately 2 years
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Bristol-Myers Squibb

Last Updated

August 3, 2020