Safety and Efficacy of Selinexor in Combination With Pembrolizumab in Recurrent Advanced Melanoma

Conditions

• Locally Advanced Unresectable or Metastatic Melanoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Selinexor — DRUG
  Dose and formulation: 80 mg (4 tablets of 20 mg)
• Pembrolizumab — DRUG
  Dose and formulation: 400 mg (25 milligrams per milliliter \[mg/mL\]) Solution

Study Details

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.

Key Dates

Start date

May 12, 2021

Status verified

Aug 2024

Primary completion

Sep 22, 2023

Completion

Sep 22, 2023

Study Design

Enrollment

15 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A: Primary resistance to Initial CPI Therapy
  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.
• Experimental: Arm B: Acquired Resistance to Initial CPI Therapy
  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.

Primary Outcome Measure

Overall Response Rate (ORR) Assessed as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 [ Time Frame: From the date of randomization until the documentation of CR or PR, whichever occurs first (up to 24 months) ]

Locations (13)

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