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A Study to Assess Safety and Efficacy of Relatlimab With Ipilimumab in Participants With Advanced Melanoma Who Progressed on Anti-PD-1 Treatment

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ClinicalTrials.gov Identifier: NCT03978611
Recruitment Status : Recruiting
First Posted : June 7, 2019
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The primary purpose of this study is to characterize the safety, tolerability, and dose-limiting toxicities (DLTs) and to determine the recommended dose of relatlimab in combination with ipilimumab (for dose escalation) and to evaluate the safety, tolerability, and preliminary efficacy of the recommended dose of relatlimab in combination with ipilimumab versus ipilimumab monotherapy (for dose expansion).

Condition or disease Intervention/treatment Phase
Melanoma Drug: Relatlimab Drug: Ipilimumab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2a Study to Evaluate the Safety, Tolerability, and Efficacy of Relatlimab Administered in Combination With Ipilimumab or Ipilimumab Alone in Participants With Unresectable or Metastatic Melanoma Who Have Progressed on Anti-PD-1 Therapy
Actual Study Start Date : July 2, 2019
Estimated Primary Completion Date : April 19, 2021
Estimated Study Completion Date : June 3, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
Drug Information available for: Ipilimumab

Arm Intervention/treatment
Experimental: Part 1: Dose Escalation Phase Drug: Relatlimab
Participants will receive IV infusion of relatlimab in Part 1 and Part 2

Drug: Ipilimumab
Participants will receive IV infusion of ipilimumab in Part 1 and Part 2.

Experimental: Part 2: Dose Expansion Phase Drug: Relatlimab
Participants will receive IV infusion of relatlimab in Part 1 and Part 2

Drug: Ipilimumab
Participants will receive IV infusion of ipilimumab in Part 1 and Part 2.




Primary Outcome Measures :
  1. Number of Participants with Adverse Events (AEs) [ Time Frame: Up to Follow-up Period (100 days after 34 cycles [1 cycle is of 3 weeks]) ]
  2. Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Up to Follow-up Period (100 days after 34 cycles [1 cycle is of 3 weeks]) ]
  3. Number of Participants With Adverse Events Including Dose Limiting Toxicity [ Time Frame: Up to 28 days after last study drug dose (approximately up to 2 years) ]
  4. Number of Participants with AEs resulting in Discontinuation [ Time Frame: Up to end of study (approximately 2.4 years) ]
  5. Number of Participants with AEs resulting in Death [ Time Frame: Up to end of study (approximately 2.4 years) ]
  6. Number of Participants with AEs resulting in Laboratory Abnormalities [ Time Frame: Up to end of study (approximately 2.4 years) ]
  7. Objective Response Rate (ORR) [ Time Frame: Approximately 2.4 years ]

Secondary Outcome Measures :
  1. Duration of response (DOR) [ Time Frame: Approximately Up to 2.4 years ]
  2. Median PFS [ Time Frame: 6 and 12 months ]
  3. Median Overall Survival (OS) [ Time Frame: 1 and 2 years ]
  4. Number of Participants with Anti-Drug Antibodies (ADA)-Positivity [ Time Frame: Up to Follow-up Period (100 days after 34 cycles [1 cycle is of 3 weeks]) ]
  5. Progression Free Survival rates (PFS rates) [ Time Frame: at 24 weeks and at 1 year ]
    Progression free survival rates (PFS rates)

  6. Overall Survival Rates (OS rates) [ Time Frame: at 1 year and at 2 years ]
    Overall Survival Rates (OS rates)

  7. Objective Response Rate (ORR) [ Time Frame: up to 2.4 years ]
    Objective Response Rate (ORR)



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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

Inclusion Criteria:

  • Must have documented progression while on a prior anti-programmed cell death protein 1 (PD-1) containing regimen limited to Nivolumab or Pembrolizumab.
  • Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test
  • Participants must have histologically confirmed advanced unresectable (Stage III) or metastatic (Stage IV) melanoma, as per AJCC staging system
  • Tumor tissue from an unresectable or metastatic site of disease must be provided for biomarker analyses.
  • BRAF wild type and mutant participants are eligible
  • Eastern Cooperative Oncology Group (ECOG) 0-1
  • Ability to comply with treatment, patient-reported outcomes (PROs), PK, and pharmacodynamic sample collection and required study follow-up

Exclusion Criteria:

  • History of uveal melanoma
  • Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome
  • Prior treatment with ipilimumab, relatlimab, or any other CTLA-4 or LAG-3 targeted agents
  • Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or HIV-1 and HIV-2 antibody.

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): NCT03978611


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

Locations
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United States, California
Local Institution Not yet recruiting
Los Angeles, California, United States, 90033
Contact: Site 0005         
Local Institution Not yet recruiting
Newport Beach, California, United States, 92658
Contact: Site 0002         
John Wayne Cancer Institute Recruiting
Santa Monica, California, United States, 90404
Contact: Steven O'Day, Site 0001         
United States, Illinois
Local Institution Not yet recruiting
Chicago, Illinois, United States, 60611
Contact: Site 0004         
United States, Michigan
Local Institution Not yet recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Site 0003         
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03978611     History of Changes
Other Study ID Numbers: CA224-083
2019-000132-25 ( EudraCT Number )
First Posted: June 7, 2019    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019

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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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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Ipilimumab
Antineoplastic Agents, Immunological
Antineoplastic Agents