NCT04768881

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

A Phase 2 Open-Label Multicenter Study to Evaluate the Safety and Efficacy of Selinexor in Combination With Pembrolizumab in Recurrent Advanced Melanoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Karyopharm Therapeutics Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Locally Advanced Unresectable or Metastatic Melanoma

Interventions

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

Timeline

• Start date: 2021-05-12
• Primary completion: 2023-09-22
• Completion: 2023-09-22
• First posted: 2021-02-24
• Last updated: 2024-08-23
• Results posted: 2024-08-23

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study