Last updated on June 2019

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


Brief description of study

To evaluate the safety and tolerability of galinpepimut-S in combination with pembrolizumab in patients with selected advanced cancers. Patients will be followed long-term for Overall Survival (OS) and safety. The study will enroll approximately 90 patients and maximum study treatment duration is approximately 2.13 years.

Detailed Study Description

This is a Phase 1/2, open-label, non-comparative, multicenter, multi-arm study of the Wilms Tumor-1 (WT1)-targeting multivalent heteroclitic peptide immunotherapeutic vaccine galinpepimut-S in combination with the programmed death-1 (PD1) inhibitor pembrolizumab in patients with selected advanced cancers. This study will assess the efficacy and safety of galinpepimut-S and pembrolizumab and investigate the effect of galinpepimut-S and pembrolizumab on various tumor types. Patients will be followed long-term for OS and safety. The study will enroll approximately 90 patients at up to 20 centers in the United States.

Indications treated are colorectal (third or fourth line), ovarian (second or third line), small cell lung cancer (second line), breast cancer (triple negative; second line), acute myelogenous leukemia (unable to attain deeper morphological response than partial [PR] on hypomethylating agents and who are not eligible for allogeneic hematopoietic stem cell transplant).

The first 2 galinpepimut-S injections will initially be administered as monotherapy every 3 weeks (Week 0 and Week 3). Thereafter, galinpepimut-S will be co-administered with pembrolizumab every 3 weeks for 4 additional administrations (for the galinpepimut-S initial immunization induction phase series; weeks 6-15) to coincide with the per label pembrolizumab dosing frequency. After that, there will be one un-paired administration of pembrolizumab (week 18), and then galinpepimut-S will be resumed on an every 3-week schedule for 6 additional doses (early immune booster phase; weeks 21-36). At the end of this phase, there will be a 12-week interval where 3 unpaired administrations of pembrolizumab will occur (weeks 39-45), and then galinpepimut-S will be resumed on an every 12-week schedule for 4 additional doses (late immune booster phase; weeks 48-84). After 84 weeks, continuing non-progressed patients will be treated with pembrolizumab alone up until week 111.

Pembrolizumab will be 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 111). Galinpepimut-S will be administered 30-60 minutes after the completion of IV infusion of pembrolizumab on Day 1 of each cycle during which the 2 drugs are being co-administered.

Clinical Study Identifier: NCT03761914

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Recruitment Status: Open


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