NCT03761914

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

A Phase 1/2 Study of Galinpepimut-S in Combination With Pembrolizumab (MK 3475) in Patients With Selected Advanced Cancers

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Sellas Life Sciences Group · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To evaluate the safety, tolerability, and anti-tumor activity of galinpepimut-S in combination with pembrolizumab in patients with selected advanced cancers.

Detailed description

This is a Phase 1/2, open-label, non-comparative, multicenter, multi-arm (basket-type) study of galinpepimut-S (a multivalent WT1 analog peptide vaccine) in combination with the programmed death-1 (PD1) inhibitor pembrolizumab, in patients with metastatic colorectal cancer (mCRC), metastatic ovarian cancer (mOvC), advanced small-cell lung cancer (SCLC), triple-negative breast cancer (TNBC), and acute myeloid leukemia (AML). Additional details of tumors and prior therapies: mCRC treated with at least two prior lines, mOvC treated with at least one prior line, SCLC treated with one prior line, TNBC treated with at least one prior line, and AML unable to attain a morphological partial response after hypomethylating agents and who are not eligible for allogeneic hematopoietic stem cell transplant. The primary objectives of the study are to assess the safety, tolerability, and anti-tumor activity of galinpepimut-S in combination with pembrolizumab. The secondary and exploratory objectives include duration of response, overall survival, and progression-free survival. The study will enroll approximately 90 patients at up to 20 centers in the United States. The first two galinpepimut-S injections will initially be administered as monotherapy every three weeks (Week 0 and Week 3). Thereafter, galinpepimut-S will be co-administered with pembrolizumab every three weeks for four 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 Q3W for six additional doses (early immune booster phase; weeks 21-36). At the end of this phase, there will be a 12-week interval where three unpaired administrations of pembrolizumab will occur (weeks 39-45), and then galinpepimut-S will be resumed on an every 12-week schedule for four 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 Q3W on Day 1 of each cycle (three week cycles) starting on Study Week 6 and continuing for up to two 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 two drugs are being co-administered.

Conditions

• Acute Myelogenous Leukemia
• Ovarian Cancer
• Colorectal Cancer
• Triple-negative Breast Cancer
• Small-cell Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	galinpepimut-S	* 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.
BIOLOGICAL	pembrolizumab	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.
OTHER	Montanide	Adjuvant
BIOLOGICAL	GM-CSF	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.

Timeline

• Start date: 2019-09-30
• Primary completion: 2022-07-05
• Completion: 2022-10-27
• First posted: 2018-12-03
• Last updated: 2024-11-19
• Results posted: 2024-11-19

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study