participants with completely resected Stage III or Stage IV melanoma MedDRA version: 21.1 Level: PT Classification code 10025671 Term: Malignant melanoma stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: PT Classification code 10025670 Term: Malignant melanoma stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - All participants must have been diagnosed with either Stage IIIA (> 1 mm tumor in lymph node)/B/C/D or Stage IV melanoma by AJCC v8 and have histologically confirmed melanoma that is completely surgically resected (free of disease) with negative margins in order to be eligible. All melanomas, except ocular melanoma, regardless of primary site of disease, will be allowed. - 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 obtained from surgical specimen or biopsy during resection collected within 90 days prior to randomization, with an associated pathology report, must be submitted to the central laboratory (preferably prior to randomization). - Participant must be = 12 years of age inclusive at the time of signing the informed consent. Except: Where local regulations and/or institutional policies do not allow for participants =65 years) yes F.1.3.1 Number of subjects for this age range 365
Exclusion criteria
Exclusion criteria: - Prior immunotherapy treatment for any prior malignancy: No prior immunotherapies are permitted (such as, but not limited to, anti-programmed death-1 (anti-PD-1), anti-programmed death ligand-1 (anti-PD-L1), anti-programmed death ligand-2 (PD-L2), or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways). - Prior treatment with LAG-3 targeted agents. - Prior therapy for melanoma except surgery for the melanoma lesion(s) and/or adjuvant radiation therapy for central nervous system lesions. - Participants with an active, known, or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. - Participants with a history of myocarditis, regardless of etiology. - Prior treatment with BRAF/MEK targeted agents.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy, as measured by RFS, provided by nivo + rela FDC vs nivolumab monotherapy in participants with completely resected Stage III/IV NED melanoma.;Secondary Objective: Key Secondary: -To compare the OS provided by nivo + rela FDC vs nivolumab monotherapy in participants with completely resected Stage III/IV NED melanoma. Other Secondary: -To assess the efficacy, as measured by distant metastasis-free survival (DMFS), provided by nivo + rela FDC vs nivolumab monotherapy in participants with completely resected Stage III/IVA/IVB NED melanoma. -To assess safety and toxicity of nivo + rela FDC vs nivolumab monotherapy in participants with completely resected Stage III/IV NED melanoma. -To evaluate investigator-assessed outcomes on next-line systemic therapies.;Primary end point(s): -RFS time as assessed by the investigator. RFS is defined as the time between the date of randomization and the first date of documented recurrence (local, regional, distant, new primary melanoma), or death due to any cause, whichever occurs first. Comparison of relatlimab and nivolumab FDC vs nivolumab monotherapy. ;Timepoint(s) of evaluation of this end point: approximately 52 months from the randomization of the first participant | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key Secondary: 1/OS is defined as the time between the date of randomization and the date of death due to any cause. Comparison of relatlimab and nivolumab FDC vs nivolumab monotherapy. Other secondary 2/DMFS, by investigator, is defined as the time between the date of randomization and the date of first distant metastasis or date of death due to any cause, whichever occurs first. Comparison of relatlimab and nivolumab FDC vs nivolumab monotherapy. 3/ Incidence and severity of AE, SAEs, AEs leading to DC, IMAEs, drug-related AEs, deaths, laboratory abnormalities, and other select AEs, in all treated participants 4/PFS2 defined as time from randomization to second recurrence/objective disease progression on next-line systemic therapy per investigator, or death from any cause, whichever occurs first. Evaluation of relatlimab and nivolumab FDC vs nivolumab monotherapy. ;Timepoint(s) of evaluation of this end point: 1/ approximately 90 months after the first participant is randomized 2, 3, 4/ approximately 52 months from the randomization of the first participant | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czechia, Czech Republic, Denmark, Finland, France, Germany, Greece, Israel, Italy, Mexico, Norway, Portugal, Romania, Spain, Sweden, Switzerland, United Kingdom, United States
Contacts
Public ContactGSM-CT
Bristol-Myers Squibb International Corporation
Outcome results
None listed