MedTrace Logo

Folate Receptor Alpha Peptide Vaccine With GM-CSF Versus GM-CSF Alone in Patients With Platinum Sensitive Ovarian Cancer

NCT02978222 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-12-15

Study results available
· View outcomes & findings →

Summary

This is a double-blind, randomized, parallel groups Phase II trial. Patients with platinum-sensitive advanced ovarian cancer, defined as a lack of progression by RECIST v1.1 criteria following completion of standard-of-care chemotherapy, including a minimum of 4 cycles of a platinum-containing regimen. Patients will be randomized to either the vaccine regimen with GM-CSF adjuvant or GM-CSF adjuvant alone as a control group. Treatment will be administered as a consolidation therapy within one year of the last administration of platinum, targeting the first remission.

Conditions

Interventions

BIOLOGICAL

FRα peptide plus Adjuvant (GM-CSF)

Intradermal injection FRα peptides, 500μg each - plus GM-CSF 125 μg

DRUG

Adjuvant (GM-CSF) Alone

Intradermal injection 125 μg GM-CSF

Sponsors & Collaborators

  • Marker Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Richard Kenney, MD · Marker Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-20
Primary Completion
2020-01-15
Completion
2020-01-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02978222 on ClinicalTrials.gov