Conditions: Locally Advanced Unresectable or Metastatic Melanoma
Keywords: Karyopharm Locally advanced unresectable or metastatic melanoma KPT-330 Recurrent advanced melanoma Selinexor Pembrolizumab
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 15
Healthy volunteers: no

Brief summary:
Approximately 40 participants with locally advanced or metastatic melanoma will be enrolled in 20 sites in the United States into 1 of the following 2 arms: Primary resistance to initial checkpoint inhibitor (CPI) therapy in Arm A and Acquired resistance to initial CPI therapy in Arm B. Participants who have disease progression (PD) after discontinuation of CPIs, especially in neoadjuvant or adjuvant therapy, will be considered to have acquired resistance in this study. Participants will receive study treatment (Selinexor and Pembrolizumab) until PD, intolerable toxicity or withdrawal from the study, whichever occurs first.

Detailed description:

Arms:
arm 1: Participants will receive a dose of 80 milligrams (mg) selinexor orally once weekly (QW) and a dose of pembrolizumab 400 mg intravenously (IV) once in every six weeks (Q6W), both on Day 1 of a 6-week cycle until progressive disease (PD), intolerable toxicity or withdrawal from the study, whichever occurs first. arm 2: Participants will receive a dose of 80 mg selinexor orally once weekly (QW) and a dose of pembrolizumab 400 mg IV Q6W, both on Day 1 of a 6-week cycle until PD, intolerable toxicity or withdrawal from the study, whichever occurs first.

Interventions: intervention 1: Selinexor intervention 2: Pembrolizumab
Intervention descriptions: intervention 1: Dose and formulation: 80 mg (4 tablets of 20 mg) intervention 2: Dose and formulation: 400 mg (25 milligrams per milliliter \[mg/mL\]) Solution

Protocol document:
Prot_000.pdf: 
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