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

Recruiting in Palo Alto (17 mi)

+12 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Sellas Life Sciences Group

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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

Research Team

Nicholas J Sarlis, MD, PhD

Principal Investigator

SELLAS Life Sciences Group, Inc.

Eligibility Criteria

Inclusion Criteria

Resolution of toxicity effect(s) from most recent prior chemotherapy to Grade 1 or less (except alopecia)

ECOG performance status of 0 or 1

For women of child-bearing potential, agreement to use adequate birth control

Exclusion Criteria

You received a live vaccine within the past month before starting the study drug.

Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to treatment

You are allergic to Montanide or any vaccine adjuvants.

Treatment Details

Interventions

• galinpepimut-S (Cancer Vaccine)
• Pembrolizumab (PD-1 Inhibitor)

Participant Groups

Group I: Triple Negative Breast Cancer (TNBC) - not opened Experimental Treatment 4 Interventions

* N=15 (planned); * TNBC previously treated with one line of prior systemic chemotherapy * Galinpepimut-S + Montanide + GM-CSF + pembrolizumab

Group II: Small Cell Lung Cancer (SCLC) - not opened Experimental Treatment 4 Interventions

* N=20 (planned); * Advanced SCLC previously treated with one line of prior systemic chemotherapy * Galinpepimut-S + Montanide + GM-CSF + pembrolizumab

Group III: Ovarian Cancer (OvC) Experimental Treatment 4 Interventions

* N=20 (planned); * Metastatic platinum-resistant or refractory OvC previously treated with ≥1 line of prior platinum-containing therapy * Galinpepimut-S + Montanide + GM-CSF + pembrolizumab

Group IV: Colorectal Cancer (CRC) - opened but since only one subject enrolled, not included for analyses Experimental Treatment 4 Interventions

* N=20 (planned); * Metastatic CRC previously treated with ≥ 2 lines of prior systematic chemotherapies * Galinpepimut-S + Montanide + GM-CSF + pembrolizumab

Group V: Acute Myelogenous Leukemia (AML) - not opened Experimental Treatment 4 Interventions

* N=15 (planned); * AML (any age) who are not eligible for allogeneic hematopoietic stem cell transplant and have been able to achieve partial response (PR) while receiving frontline therapy with hypomethylating agents (HMAs) * Galinpepimut-S + Montanide + GM-CSF + pembrolizumab

Who Is Running the Clinical Trial?

Sellas Life Sciences Group

Lead Sponsor

Trials

9

Recruited

770+

LumaBridge

Collaborator

Trials

6

Recruited

410+

LumaBridge

Industry Sponsor

Trials

5

Recruited

380+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Cancer Insight, LLC

Industry Sponsor

Trials

10

Recruited

520+