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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04112498
Recruitment Status : Completed
First Posted : October 2, 2019
Last Update Posted : April 6, 2023
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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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
Cancer Drug: relatlimab Drug: nivolumab Drug: rHuPH20 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : October 1, 2019
Actual Primary Completion Date : February 27, 2023
Actual Study Completion Date : February 27, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: nivolumab + relatlimab + rHuPH20 Drug: relatlimab
Specified dose on Specified days

Drug: nivolumab
Specified dose on Specified days
Other Name: Opdivo

Drug: rHuPH20
Specified dose on Specified days
Other Name: Enhanze


Outcome Measures
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Primary Outcome Measures :
  1. maximum observed serum concentration (Cmax) [ Time Frame: approximately 60 days ]
  2. time of maximum observed serum concentration (Tmax) [ Time Frame: approximately 60 days ]
  3. area under the time-concentration curve over the dosing interval AUC (TAU) [ Time Frame: approximately 60 days ]
  4. Observed concentration at the end of the dosing interval (Ctau) [ Time Frame: approximately 60 days ]
  5. Incidence of Serious Adverse Events (SAEs) [ Time Frame: approximately 2 years ]
  6. Incidence of Adverse Events (AEs) [ Time Frame: approximately 2 years ]
  7. Incidence of Adverse Events leading to discontinuation [ Time Frame: approximately 2 years ]
  8. Number of deaths [ Time Frame: approximately 2 years ]
  9. Number of laboratory abnormalities [ Time Frame: approximately 2 years ]

Secondary Outcome Measures :
  1. Incidence of Adverese Events (AEs) in the broad SMQ of Anaphylactic Reaction [ Time Frame: approximately 2 years ]
  2. Number of events within the hypersensitivity/infusion reaction select AE category [ Time Frame: approximately 2 years ]
  3. Incidence of anti-relatlimab antibodies and neutralizing antibodies (if applicable) [ Time Frame: approximately 2 years ]
  4. Incidence of anti-nivolumab antibodies and neutralizing antibodies (if applicable) [ Time Frame: approximately 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04112498


Locations
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United States, New Jersey
Local Institution - 0001
Hackensack, New Jersey, United States, 07601
Sponsors and Collaborators
Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04112498    
Other Study ID Numbers: CA224-087
First Posted: October 2, 2019    Key Record Dates
Last Update Posted: April 6, 2023
Last Verified: April 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nivolumab
Relatlimab
Antineoplastic Agents, Immunological
 Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action