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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04112498
Collaborator
(none)
24
Enrollment
1
Location
1
Arm
34.6
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1, Multi-Tumor, Bioavailability Study of Relatlimab in Combination With Nivolumab
Actual Study Start Date :
Oct 1, 2019
Anticipated Primary Completion Date :
Aug 17, 2022
Anticipated Study Completion Date :
Aug 18, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. maximum observed serum concentration (Cmax) [approximately 60 days]

    2. time of maximum observed serum concentration (Tmax) [approximately 60 days]

    3. area under the time-concentration curve over the dosing interval AUC (TAU) [approximately 60 days]

    4. Observed concentration at the end of the dosing interval (Ctau) [approximately 60 days]

    5. Incidence of Serious Adverse Events (SAEs) [approximately 2 years]

    6. Incidence of Adverse Events (AEs) [approximately 2 years]

    7. Incidence of Adverse Events leading to discontinuation [approximately 2 years]

    8. Number of deaths [approximately 2 years]

    9. Number of laboratory abnormalities [approximately 2 years]

    Secondary Outcome Measures

    1. Incidence of Adverese Events (AEs) in the broad SMQ of Anaphylactic Reaction [approximately 2 years]

    2. Number of events within the hypersensitivity/infusion reaction select AE category [approximately 2 years]

    3. Incidence of anti-relatlimab antibodies and neutralizing antibodies (if applicable) [approximately 2 years]

    4. Incidence of anti-nivolumab antibodies and neutralizing antibodies (if applicable) [approximately 2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hackensack University Medical Center Hackensack New Jersey United States 07601-1914

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT04112498
    Other Study ID Numbers:
    • CA224-087
    First Posted:
    Oct 2, 2019
    Last Update Posted:
    Sep 16, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Nivolumab

    Study Results

    No Results Posted as of Sep 16, 2021