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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04112498
Recruitment Status : Recruiting
First Posted : October 2, 2019
Last Update Posted : August 5, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 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
Estimated Primary Completion Date : August 18, 2022
Estimated Study Completion Date : August 18, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

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




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 ]


Information from the National Library of Medicine

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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


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
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601-1914
Contact: Martin Gutierrez, Site 0001    201-996-2000      
Sponsors and Collaborators
Bristol-Myers Squibb
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: August 5, 2020
Last Verified: August 2020

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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
Antineoplastic Agents, Immunological
Antineoplastic Agents