At a glance
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A Phase 1/2 Study of Galinpepimut-S in Combination With Pembrolizumab (MK 3475) in Patients With Selected Advanced Cancers
In Brief
A Phase 2 clinical trial evaluating galinpepimut-S, pembrolizumab, and 2 other interventions for Acute Myelogenous Leukemia and 4 related conditions. Completed, enrolled 26 participants across 12 sites.
Detailed Summary
To evaluate the safety, tolerability, and anti-tumor activity of galinpepimut-S in combination with pembrolizumab in patients with selected advanced cancers.
Study Details
Timeline
Interventions
* 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.