We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    ca224-098
Previous Study | Return to List | Next Study

A Study to Assess Adjuvant Immunotherapy With Nivolumab Plus Relatlimab Versus Nivolumab Alone After Complete Resection of Stage III-IV Melanoma (RELATIVITY-098)

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: NCT05002569
Recruitment Status : Recruiting
First Posted : August 12, 2021
Last Update Posted : September 22, 2022
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief Summary:
The purpose of this study is to assess nivolumab plus relatlimab fixed-dose combination (FDC) versus nivolumab alone in participants with completely resected stage III-IV melanoma.

Condition or disease Intervention/treatment Phase
Melanoma Biological: Nivolumab Biological: Nivolumab + Relatlimab Fixed Dose Combination Phase 3

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1050 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-blind Study of Adjuvant Immunotherapy With Nivolumab + Relatlimab Fixed-dose Combination Versus Nivolumab Monotherapy After Complete Resection of Stage III-IV Melanoma
Actual Study Start Date : October 19, 2021
Estimated Primary Completion Date : December 15, 2025
Estimated Study Completion Date : December 15, 2025

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma
Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Arm A: Nivolumab Plus Relatlimab
Combination
Biological: Nivolumab + Relatlimab Fixed Dose Combination
Specified dose on specified days
Other Names:
  • BMS-986213
  • Opdualag

Experimental: Arm B: Nivolumab
Monotherapy
Biological: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
  • BMS-936558




Primary Outcome Measures :
  1. Recurrence-Free Survival (RFS) time per Investigator assessment [ Time Frame: Until recurrence, up to 59 months ]

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Until death, up to 96 months ]
  2. Distant Metastasis-Free Survival (DMFS) time per Investigator assessment [ Time Frame: Until distant progression, up to 96 months ]
  3. Incidence of Adverse Events (AEs) [ Time Frame: 30 days from participant's last dose ]
  4. Severity of AEs [ Time Frame: 30 days from participant's last dose ]
  5. Incidence of Serious Adverse Events (SAEs) [ Time Frame: 30 days from participant's last dose ]
  6. Severity of SAEs [ Time Frame: 30 days from participant's last dose ]
  7. Incidence of AEs leading to discontinuation (DC) [ Time Frame: 30 days from participant's last dose ]
  8. Severity of AEs leading to DC [ Time Frame: 30 days from participant's last dose ]
  9. Incidence of immune-mediated AEs (IMAEs) [ Time Frame: 135 days from participant's last dose ]
  10. Severity of IMAEs [ Time Frame: 135 days from participant's last dose ]
  11. Incidence of drug related AEs [ Time Frame: 30 days from participant's last dose ]
  12. Severity of drug related AEs [ Time Frame: 30 days from participant's last dose ]
  13. Incidence of deaths [ Time Frame: 30 days from participant's last dose ]
  14. Incidence of clinically significant changes in clinical laboratory values: Hematology tests [ Time Frame: 30 days from participant's last dose ]
  15. Incidence of clinically significant changes in clinical laboratory values: Chemistry tests [ Time Frame: 30 days from participant's last dose ]
  16. Duration of Treatment on next line therapies [ Time Frame: Until end of next-line therapy, up to 5 years ]
  17. Progression-Free Survival 2 (PFS2) [ Time Frame: Until second recurrence, up to 5 years ]


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.


Layout table for eligibility information
Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have been diagnosed with either Stage IIIA (> 1 mm tumor in lymph node)/B/C/D or Stage IV melanoma by American Joint Committee on Cancer (AJCC) v8 and have histologically confirmed melanoma that is completely surgically resected (free of disease) with negative margins in order to be eligible
  • Participants ≥ 18 years of age must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1. Adolescent participants between 12 and 17 years of age must have a Lansky/Karnofsky performance score ≥ 80%
  • Complete resection must be performed within 90 days prior to randomization
  • All participants must have disease-free status documented by a complete physical examination within 14 days prior to randomization and imaging studies within 35 days prior to randomization
  • Tumor tissue must be provided for biomarker analyses

Exclusion Criteria:

  • History of ocular melanoma
  • Untreated/unresected CNS metastases or leptomeningeal metastases
  • Active, known, or suspected autoimmune disease
  • Participants with serious or uncontrolled medical disorder
  • Prior immunotherapy treatment for any prior malignancy: No prior immunotherapies are permitted
  • Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 4 weeks prior to screening
  • History of myocarditis, regardless of etiology. Other protocol-defined inclusion/exclusion criteria 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): NCT05002569


Contacts
Layout table for location contacts
Contact: BMS Study Connect Contact Center http://www.bmsstudyconnect.com/ 855-907-3286 Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT # and Site #.

Locations
Show Show 177 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Layout table for investigator information
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT05002569    
Other Study ID Numbers: CA224-098
2021-001641-13 ( EudraCT Number )
First Posted: August 12, 2021    Key Record Dates
Last Update Posted: September 22, 2022
Last Verified: September 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bristol-Myers Squibb:
Melanoma
Relatlimab
Nivolumab
Opdivo
Additional relevant MeSH terms:
Layout table for MeSH terms
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Nivolumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action