drugset / Trial / NCT04768881

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

NCT04768881

Phase 2 Terminated 15 enrolled Karyopharm Therapeutics Inc
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2021-05-12
Primary completion
2023-09-22
Completion
2023-09-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Pembrolizumab Monoclonal antibody 400 mg Intravenous
Subject Selinexor Other / unclassified 80 mg Oral

Indications

No indication recorded.