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

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

melanoma (AJCC Cancer 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.
Participants must have had a negative sentinel lymph node biopsy.
Patients 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 lab prior to
randomization.
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

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

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