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A Phase II Randomized Study of Adjuvant Versus NeoAdjuvant MK-3475 (Pembrolizumab) for Clinically Detectable Stage III-IV High-Risk Melanoma

A Phase II Randomized Study of Adjuvant Versus NeoAdjuvant MK-3475 (Pembrolizumab) for Clinically Detectable Stage III-IV High-Risk Melanoma

  • Clinical Trial Information

    Trial Contact: Frankos, Marie; Tan, Ciara Natasha

    Trial Phone: 321.841.7303 ; 321.841.7413

  • IRB No: S1801

    Protocol Abbrev: S1801

    Principal Investigator: Sajeve Samuel Thomas, MD

    Phase: Drug: Phase II

    Age Group: Adult

    Secondary Protocol No: S1801

    Therapies Involved: Oncology: Neo-adjuvant

    ClinicalTrials.gov ID: 03698019

  • Objective

    To compare event-free survival (EFS) in patients with high-risk resectable melanoma randomized to neoadjuvant MK-3475 (pembrolizumab) with patients randomized to adjuvant MK-3475 (pembrolizumab).

  • Key Eligibility

    STep 1 Registration

    •  Patients must have resectable melanoma in order to be eligible for this study. Patients must have clinically detectable stage III (clinically detectable N1b, N1c, N2b, N2c, N3b and N3c) or stage IV resectable melanoma. Patients with melanoma of mucosal or acral origin are eligible. Patients with melanoma of uveal origin are not eligible. Patients with a history of brain metastases are not eligible. Clinically detectable is defined as disease that is apparent and measurable via physical examination or radiographic imaging

    •  STEP 2 REGISTRATION (SURGERY)
    •  Patients randomized to arm 2 (neoadjuvant arm) must be willing to submit tissue to determine pathologic response regardless of number of pre-operative doses of MK-3475 (pembrolizumab) received. Determination of pathologic response cannot be done on less than the full surgical specimen.
    •  Patients must have disease assessments by PET-CT with iodinated CT contrast (i.e. diagnostic quality CT) or CT chest/abdomen/pelvis with IV contrast, and neck CT with IV contrast if primary head and neck melanoma, performed within 42 days (and no more than 49 days) before the planned date of surgery. MRI combined with non-contrast CT is an acceptable alternative for patients with CT contrast allergy, but imaging must encompass total body.
    •  Patients must register to step 2 within 3 days prior to planned date of surgery.

    •  STEP 3 REGISTRATION (ADJUVANT THERAPY)

    •  Patients must have undergone surgery prior to Step 3 registration. The Step 2 surgery must have completely resected their melanoma.
    ◦Patients with gross positive residual disease at the time of surgery do not qualify as having disease-free status, and, therefore, such patients are not eligible to register for adjuvant therapy.
    ◦Patients with microscopic residual disease (i.e., positive margins) can be treated with re-excision or radiation, per site discretion, to render the patient disease-free prior to registration of adjuvant therapy.
    ◦Disease-free status must be documented by a complete physical examination and radiographic imaging studies within 42 days prior to Step 3 registration. Imaging studies must include a total body PET-CT that is of diagnostic quality (i.e., iodinated contrast), or a CT of the chest, abdomen, and pelvis.
    ◦For patients with melanoma arising from the head and neck, dedicated neck imaging (CT with IV contrast with PET-CT through the region) is required.
    ◦If the patient has had unknown primary with disease in the axilla, neck imaging is required to assure the region is clear of cancer.
    ◦CT imaging should be done with intravenous contrast if there are no contraindications for it.
    ◦Any other clinically-indicated imaging studies if performed (e.g., bone scan) must show no evidence of disease.

    •  Patients must be registered to step 3 no more than 84 days after date of surgery.
    •  Patients with R0 or R1 resections must have disease-free status documented by a complete physical examination and imaging studies within 42 days prior to step 3 registration. These patients must have disease assessments by PET-CT with iodinated CT contrast (i.e. diagnostic quality CT) or CT chest/abdomen/pelvis with IV contrast, and neck CT with IV contrast if primary head and neck melanoma. MRI combined with non-contrast CT is an acceptable alternative for patients with CT contrast allergy, but imaging must encompass total body.
    •  Patients with R2 resections are not eligible for step 3 and must be removed from study treatment