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

Phase 2

Terminated

• Conditions: Platinum Sensitive Ovarian Cancer; Ovarian Cancer
• Interventions: Drug: Adjuvant (GM-CSF) Alone; Biological: FRα peptide plus Adjuvant (GM-CSF)

• Registration Number: NCT02978222
• Lead Sponsor: Marker Therapeutics, Inc.

Brief 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.

Detailed Description

This is a multicenter double-blind controlled randomized Phase II study to evaluate the activity of folate receptor alpha (FRα) peptide vaccine as a consolidation treatment following completion of no less than 4 cycles of a platinum containing regimen in patients with platinum-sensitive, non-mucinous ovarian, fallopian tube or primary peritoneal cancer.

The patients will have demonstrated a tumor response or stable disease upon their last regimen (per RECIST v1.1 and/or CA125 GCIG criteria) prior to enrolment in this study.

Following randomization, patients will be administered TPIV200 with GM-CSF adjuvant or GM-CSF control alone. Patients will have booster doses and tumor assessments done every 12 weeks ± 1 week for up to 1.5 years, until objective disease progression or the patient withdraws consent. Tumor responses will be assessed at the study sites by evaluating tumor images/scans according to RECIST v1.1.

Study Timeline

• Study First Submitted: 2016-11-22
• Study First Submitted QC: 2016-11-28
• Study First Posted: 2016-11-30
• Study Start: 2017-07-20
• Primary Completion: 2020-01-15
• Study Completion: 2020-01-15
• Status Verified: 2020-02
• Results First Submitted: 2022-08-22
• Results First Submitted QC: 2022-11-21
• Last Update Submitted: 2022-11-21
• Results First Posted: 2022-12-15
• Last Update Posted: 2022-12-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adjuvant (GM-CSF) Alone	Adjuvant (GM-CSF) Alone	GM-CSF adjuvant alone ID administration monthly for 6 months followed by booster administrations every 3 months for up to 1.5 years
FRα peptide plus adjuvant (GM-CSF)	FRα peptide plus Adjuvant (GM-CSF)	FRα peptide vaccine with GM-CSF adjuvant ID administration monthly for 6 months followed by booster administrations every 3 months for up to 1.5 years

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	2 years	Time to disease progression or recurrence of ovarian cancer defined as disease progression by RECIST 1.1., disease recurrence, death without progression or CA125 progression

Secondary Outcome Measures

Name	Time	Method
Overall Survival (OS)	2 years	Death with or without ovarian cancer progression
Best Overall Response Rate	2 years	Best overall response defined as sum of Complete Responses and Partial Responses in the subset of patients with measurable tumor lesions at baseline.; Best overall response is a binary endpoint and defined as a best overall response of either CR or PR among subjects with measurable lesions at baseline, using RECIST v1.1.; Disease control rate is the percentage of subjects with a response of CR, PR, or SD or non-CR/non-PR vs PD among subjects with measurable lesions at baseline.
Disease Control Rate	2 years	Disease control rate defined as the sum of Complete Responses, Partial Responses and Stable Disease.; Best overall response is a binary endpoint and defined as a best overall response of either CR or PR among subjects with measurable lesions at baseline, using RECIST v1.1.; Disease control rate is the percentage of subjects with a response of CR, PR, or SD or non-CR/non-PR vs PD among subjects with measurable lesions at baseline.

Trial Locations

Locations (18)

The Stamford Hospital/Bennett Cancer Center; 🇺🇸 Stamford, Connecticut, United States

Research Partners; 🇺🇸 Jackson, Mississippi, United States

Mayo Clinic Cancer Center; 🇺🇸 Phoenix, Arizona, United States

Tennessee Oncology/Sarah Cannon Research Institute; 🇺🇸 Nashville, Tennessee, United States

MidAmerica Division, Inc. c/o Research Medical Center; 🇺🇸 Kansas City, Missouri, United States

Mt. Sinai Comprehensive Cancer Center; 🇺🇸 Miami Beach, Florida, United States

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States

Hematology/Oncology Lenox Hill Hospital; 🇺🇸 New York, New York, United States

Women's Cancer Research Foundation; 🇺🇸 Newport Beach, California, United States

University Of New Mexico Comprehensive Cancer Center; 🇺🇸 Albuquerque, New Mexico, United States

UAB Gynecology Oncology; 🇺🇸 Birmingham, Alabama, United States

Mayo Clinic Rochester; 🇺🇸 Rochester, Minnesota, United States

Florida Cancer Specialist; 🇺🇸 West Palm Beach, Florida, United States

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States

Abington Memorial Hospital; 🇺🇸 Abington, Pennsylvania, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

OHSU; 🇺🇸 Portland, Oregon, United States