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Brief Title: Safety and Efficacy of Selinexor in Combination With Pembrolizumab in Recurrent Advanced Melanoma
Official Title: A Phase 2 Open-Label Multicenter Study to Evaluate the Safety and Efficacy of Selinexor in Combination With Pembrolizumab in Recurrent Advanced Melanoma
Study ID: NCT04768881
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:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
UCLA, Los Angeles, California, United States
TOI Clinical Research, Pasadena, California, United States
BRCR Global, Plantation, Florida, United States
Minnesota Oncology Hematology, Minneapolis, Minnesota, United States
Great Plains Health, North Platte, Nebraska, United States
John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
New York Oncology Hematology, Albany, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
OH Care Clinical Trials, Cincinnati, Ohio, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Texas Oncology-Austin Central, Austin, Texas, United States
Texas Oncology - Baylor Sammons Center, Dallas, Texas, United States