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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Intradermal injection FRα peptides, 500μg each - plus GM-CSF 125 μg
Intradermal injection 125 μg GM-CSF
UAB Gynecology Oncology
Birmingham, Alabama, United States
Mayo Clinic Cancer Center
Phoenix, Arizona, United States
Women's Cancer Research Foundation
Newport Beach, California, United States
The Stamford Hospital/Bennett Cancer Center
Stamford, Connecticut, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Mt. Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Florida Cancer Specialist
West Palm Beach, Florida, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Research Partners
Jackson, Mississippi, United States
...and 8 more locations
Progression Free Survival
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
Time frame: 2 years
Overall Survival (OS)
Death with or without ovarian cancer progression
Time frame: 2 years
Best Overall Response Rate
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.
Time frame: 2 years
Disease Control Rate
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.
Time frame: 2 years
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