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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

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: NCT03978611
Recruitment Status : Recruiting
First Posted : June 7, 2019
Last Update Posted : October 28, 2020
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 20, 2023
Estimated Study Completion Date : July 19, 2024

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Hoag Memorial Hospital Presbyterian Recruiting
Los Angeles, California, United States, 90033
Contact: Jacob Thomas, Site 0002    949-764-6743      
USC/Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Jacob Thomas, Site 0005    323-226-2452      
John Wayne Cancer Institute Recruiting
Santa Monica, California, United States, 90404
Contact: Steven O'Day, Site 0001    310-582-7456      
United States, Florida
Local Institution Not yet recruiting
Miami, Florida, United States, 33136
Contact: Site 0015         
United States, Illinois
Northwestern University, Feinberg School of Medicine Recruiting
Chicago, Illinois, United States, 60611
Contact: Sunandana Chandra, Site 0004    312-926-2984      
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Christopher Lao, Site 0003         
United States, New Jersey
Local Institution Not yet recruiting
Morristown, New Jersey, United States, 07960
Contact: Site 0008         
United States, Texas
Local Institution Not yet recruiting
San Antonio, Texas, United States, 78229
Contact: Site 0013         
United States, Virginia
Local Institution Not yet recruiting
Charlottesville, Virginia, United States, 22908
Contact: Site 0011         
Belgium
Local Institution Not yet recruiting
Antwerpen, Belgium, 2020
Contact: Site 0017         
Local Institution Not yet recruiting
Bruxelles, Belgium, 1000
Contact: Site 0018         
Spain
Local Institution Not yet recruiting
Barcelona, Spain, 08035
Contact: Site 0026         
Local Institution Not yet recruiting
Cordoba, Spain, 14004
Contact: Site 0030         
Local Institution Not yet recruiting
Hospitalet de Llobregat - Barcelona, Spain, 08908
Contact: Site 0027         
Local Institution Not yet recruiting
Madrid, Spain, 28034
Contact: Site 0029         
Local Institution Not yet recruiting
San Sebastian, Spain, 20014
Contact: Site 0031         
Local Institution Not yet recruiting
Valencia, Spain, 46009
Contact: Site 0028         
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    
Other Study ID Numbers: CA224-083
2019-000132-25 ( EudraCT Number )
First Posted: June 7, 2019    Key Record Dates
Last Update Posted: October 28, 2020
Last Verified: October 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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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