Galinpepimut-S in Combination With Pembrolizumab in Patients With Selected Advanced Cancers

"* Induction phase: the first two GPS + Montanide injections are administered Q3W on Week 0 and Week 3. Thereafter, GPS + Montanide is co-administered with pembrolizumab Q3W (Weeks 6, 9, 12, 15, 18).~* Early immune booster phase: A single administration of pembrolizumab (Week 21), and then GPS + Montanide resumes Q3W for six additional doses (Weeks 24, 27, 30, 33, 36, 39).~* Following the early immune booster, there is a 12-week interval of pembrolizumab administration (Weeks 42, 45, 48, 51), and then GPS is resumed every 12 weeks for an additional four doses.~* After 84 weeks, participants who had not progressed will continue in the study and be treated with pembrolizumab alone."

Pembrolizumab is administered at a dose of 200 mg intravenously every 3 weeks on Day 1 of each cycle (3-week cycles) starting on Study Week 6 and continuing for up to 2 years thereafter (Study Week 108). Pembrolizumab is to be administered no earlier than 30 minutes after the administration of GPS on Day 1 of each cycle.

Adjuvant

Participants receive 70 μg GM-CSF SC on Day -2 and on Day 1 before each GPS injection. The GM-CSF injections occur at the same anatomical site of the next planned study treatment injection.