Efficacy Study of Nivolumab Compared to Placebo in Prevention of Recurrence of MelanomaAfter Complete Resection of Stage IIB/C Melanoma (CheckMate 76K)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1059

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: 4
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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials