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

NCT03761914 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2024-11-19

Study results available
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Summary

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • LumaBridge

    collaborator INDUSTRY

  • Sellas Life Sciences Group

    lead INDUSTRY

Principal Investigators

  • Nicholas J Sarlis, MD, PhD · SELLAS Life Sciences Group, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-30
Primary Completion
2022-07-05
Completion
2022-10-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03761914 on ClinicalTrials.gov