Selinexor + Pembrolizumab for Melanoma

Recruiting in Palo Alto (17 mi)

+13 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Karyopharm Therapeutics Inc

Stay on your current meds

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Adults over 18 with advanced melanoma that's not treatable by surgery and has worsened after immunotherapy can join. They should have tried at most two prior therapies, have measurable disease, stable brain metastases if any, good performance status, and agree to contraception. Excluded are those with eye melanoma, active brain involvement or infections needing strong antibiotics recently.

Participant Groups

The trial is testing Selinexor combined with Pembrolizumab in patients who either initially resisted or later developed resistance to checkpoint inhibitor therapy for advanced melanoma. Participants will continue treatment until disease progression, unacceptable side effects occur or they choose to leave the study.

2Treatment groups

Experimental Treatment

Group I: Arm B: Acquired Resistance to Initial CPI TherapyExperimental Treatment2 Interventions

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.

Group II: Arm A: Primary resistance to Initial CPI TherapyExperimental Treatment2 Interventions

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.

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

🇺🇸 Approved in United States as KEYTRUDA for: