A Phase 3 Randomized Double-Blind Study of Adjuvant Immunotherapy with Nivolumab versus Placebo after Complete Resection of Stage IIB/C Melanoma (CA209-76K)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1) Participants must have been diagnosed with stage IIB/C cutaneous melanoma and have histologically confirmed melanoma that is completely surgically resected with documented negative margins (per local standard) for disease on resected specimens. 2) Tumor tissue from the resected site of disease must be provided to the central lab prior to randomization. 3) 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 s 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.

You may not be eligible for this study if the following are true:

  • 1) History of ocular and mucosal melanoma. 2) 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. 3) 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. 4) 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 g daily prednisone equivalent, are permitted in the absence of active autoimmune disease.

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