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

NCT: NCT03698019 · Status: ACTIVE NOT RECRUITING · Phase: Phase 2 · Sponsor: National Cancer Institute (NCI) · Started: 2019-02-15 · Est. Completion: 2026-10-30

Official Summary

This phase II trial studies how pembrolizumab works before and after surgery in treating patients with stage III-IV high-risk melanoma. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab before and after surgery may work better compared to after surgery alone in treating melanoma.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Eligibility Criteria

Inclusion Criteria:

* STEP 1 REGISTRATION (RANDOMIZATION): 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 1 REGISTRATION (RANDOMIZATION): Patients are eligible for this trial either at initial presentation of their melanoma or at the time of the first detected nodal, satellite/in-transit, distant metastases, or recurrent disease in prior lymphadenectomy basin or distant site. Nodal, satellite/in-transit metastasis, distant metastases or disease in a prior complete lymphadenectomy basin must have been confirmed histologically by hematoxylin (H) \& eosin (E) stained slides.
* STEP 1 REGISTRATION (RANDOMIZATION): Patients with multiple regional nodal basin involvement are eligible. Gross or microscopic extracapsular nodal extension is permitted.
* STEP 1 REGISTRATION (RANDOMIZATION): Patients must have histologically proven stage IIIB or higher. This would entail pathologic confirmation beyond the primary or initial diagnosis of melanoma involving fine needle aspiration cytology or biopsy confirmation of any N-category or M-category resectable site.
* STEP 1 REGISTRATION (RANDOMIZATION): Patients must not have received previous neoadjuvant treatment for their melanoma. Patients may have received prior non-immunotherapy adjuvant therapy. Patients must not have had prior immunotherapy including, but not limited to ipilimumab, interferon alfa-2b, high dose interleukin (IL)-2, pegylated-interferon (PEG-IFN), anti-PD-1, anti-PD-L1 intra-tumoral, or vaccine therapies. Patients must not be planning to receive any of the prohibited therapies during treatment phases on the study.
* STEP 1 REGISTRATION (RANDOMIZATION): Patients must not be planning to receive concomitant other biologic therapy, hormonal therapy, other chemotherapy, surgery, while on protocol therapy.
* STEP 1 REGISTRATION (RANDOMIZATION): Patients may have received prior radiation therapy, including after prior surgical resection. All adverse events associated with prior surgery and radiation therapy must have resolved to =\< grade 1 prior to randomization.
* STEP 1 REGISTRATION (RANDOMIZATION): Patients must be \>= 18 years of age
* STEP 1 REGISTRATION (RANDOMIZATION): All patients must have disease status documented by a complete physical examination and imaging studies within 42 days prior to randomization. Imaging studies must include a CT of the chest, abdomen and pelvis with intravenous contrast (unless contraindicated). For patients with melanoma arising from the head and neck, dedicated neck imaging (CT with intravenous contrast is required. If the patient has unknown primary with disease in the axilla, neck imaging is required CT imaging must be done with intravenous contrast if there are no contraindications for it. Extremity melanomas must be imaged using CT with intravenous contrast or MRI with and without gadolinium

  * Note: PET-CT scans are NOT acceptable to establish eligibility. Non-iodinated CT scans that are part of common PET-CT imaging protocols do not provide contrast for difficult to ascertain areas such as the neck and liver, and do not provide enough CT detail to perform appropriate RECIST 1.1 measurements. As such, a PET-CT with non-contrast CT or non-diagnostic quality CT images is considered insufficient for the detection of melanoma.
* STEP 1 REGISTRATION (RANDOMIZATION): All patients must have a CT or magnetic resonance imaging (MRI) of the brain within 42 days prior to randomization. The brain CT or MRI should be performed with intravenous contrast (unless contraindicated).
* STEP 1 REGISTRATION (RANDOMIZATION): Absolute neutrophil count (ANC) \>= 1,500/microliter (mcL) (within 42 days prior to randomization).
* STEP 1 REGISTRATION (RANDOMIZATION): Platelets \>= 100,000/mcL (within 42 days prior to randomization).
* STEP 1 REGISTRATION (RANDOMIZATION): Hemoglobin \>= 10 g/dL (within 42 days prior to randomization).
* STEP 1 REGISTRATION (RANDOMIZATION): Total bilirubin =\< 1.5 x institutional upper limit of normal (IULN) (except patients with Gilbert's syndrome, who must have a total bilirubin \< 3.0 mg/dL) (within 42 days prior to randomization).
* STEP 1 REGISTRATION (RANDOMIZATION): Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 2 x IULN (within 42 days prior to randomization).
* STEP 1 REGISTRATION (RANDOMIZATION): Alkaline phosphatase =\< 2 x IULN (within 42 days prior to randomization).
* STEP 1 REGISTRATION (RANDOMIZATION): Patients must have lactate dehydrogenase (LDH) performed within 42

Trial Locations

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AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.