drugset / Trial / NCT04768881
Safety and Efficacy of Selinexor in Combination With Pembrolizumab in Recurrent Advanced Melanoma
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pembrolizumab | Monoclonal antibody | 400 mg | Intravenous |
| Subject | Selinexor | Other / unclassified | 80 mg | Oral |
Indications
No indication recorded.