Completely resected Stage IIb/c melanoma subjects. MedDRA version: 21.1 Level: LLT Classification code 10053571 Term: Melanoma System Organ Class: 100000004864
Conditions
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) Participants must have been diagnosed with stage IIB/C cutaneous melanoma (AJCC Staging, 8th edition) and have histologically confirmed melanoma that is completely surgically resected with documented negative margins (per local standard) for disease on resected specimens. All melanomas, except ocular and mucosal melanoma, regardless of primary site of disease will be allowed. b) Complete resection must be performed within 12 weeks prior to randomization. Note: In case of delays exceeding 12 weeks due to unforeseen circumstances, the eligibility should be discussed with the Medical Monitor or designee. Participants must have had a negative sentinel lymph node biopsy. Participants in whom a sentinel lymph node biopsy procedure could not be done or a sentinel lymph node was not detected are not eligible. c) Participants must have disease-free status documented by a complete physical examination (within 14 days) and imaging studies within 4 weeks (28 days) prior to randomization. Imaging studies must include CT scans of the chest/abdomen/pelvis or CT scan of the chest and MRI scans of the abdomen and pelvis, and all known sites of resected disease (lymph nodes = 15 mm in short axis). Participants with signs and symptoms consistent with brain metastases should have imaging studies done to rule out the presence of brain metastases. d) Has not been previously treated for melanoma beyond complete surgical resection of the melanoma lesion. e) Has recovered adequately from toxicity and/or complications from surgery prior to study start. f) ECOG performance status of 0 or 1 at the time of enrollment g) Tumor tissue (minimum of 15 unstained slides or 1 FFPE block) from the resected site of disease must be provided to the central laboratory prior to randomization. If the required tumor tissue content cannot be provided, the eligibility should be discussed with the Medical Monitor or designee. Are the trial subjects under 18? yes Number of subjects for this age range: 3 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 470 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 586
Exclusion criteria
Exclusion criteria: a) History of ocular and mucosal melanoma. b) Participants with 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. c) Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast. d) Participants with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease. e) Women who are pregnant or breastfeeding f) Participants with serious or uncontrolled medical disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy, as measured by recurrencefree survival (RFS), provided by nivolumab monotherapy versus placebo in participants with completely resected stage IIB/C melanoma with no evidence of disease;Secondary Objective: - To compare the overall survival (OS) provided by nivolumab monotherapy versus placebo in participants with completely resected stage IIB/C melanoma with no evidence of disease, who are at high risk for recurrence. - To assess safety and toxicity of nivolumab monotherapy in participants with completely resected stage IIB/C melanoma with no evidence of disease. - To evaluate distant metastases-free survival (DMFS) - To evaluate investigator-assessed outcomes on nextline therapies.;Primary end point(s): RFS;Timepoint(s) of evaluation of this end point: Censoring rules for the primary analysis of RFS are presented in Table 10.3.1.1-1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - OS - AE, clinical laboratory values, vital signs, ECGs, or other safety biomarkers - DMFS - Objective response rates (if applicable) - Duration of treatment on next-line therapies - Progression-free survival through next-line therapy (PFS2) is defined as the time from randomization to second recurrence/objective disease progression after the start of the next-line of systemic anti-cancer therapy, or to the start of a second next-line systemic therapy, or to death from any cause, whichever occurs first - End-of-next-line-treatment: To be used for situations where PFS2 cannot be reliably determined. Event defined as end or discontinuation of next-line treatment, second objective disease progression, or death from any cause, whichever occurs first.;Timepoint(s) of evaluation of this end point: - For participants without documentation of death, OS will be censored on the last date the participant was known to be alive. OS will be followed continuously while participants are on the study drug and every 12 weeks after participants discontinue the study drug. - Censoring rules for the analysis of DMFS are presented in Table 10.3.1.2-1. - The Investigator-Assessed Outcomes on Next-Line Therapies endpoints will be analyzed using a two-sided log-rank test at the overall significance level of 5% (two-sided) in all randomized participants. - Safety and tolerability of nivolumab and placebo will be measured by the incidence of adverse events, serious adverse events, deaths, and laboratory abnormalities. | — |
Countries
Australia, Austria, Belgium, Canada, Czechia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Norway, Poland, Romania, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactGSM-CT
Bristol-Myers Squibb International Corporation
Outcome results
None listed