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

2016-12-01 16:08:21 | BioPortfolio

Summary

This is a blinded, randomized, parallel groups Phase II trial. Patients with platinum sensitive ovarian cancer (defined as time to progression > 6 months in the penultimate platinum containing regimen) and who had either a tumor response or a stable disease upon completing their last platinum containing regimen will be randomized to either vaccine regimen with GM-CSF adjuvant or GM-CSF adjuvant alone as a control group. Treatment will be administered as a consolidation therapy within 8 weeks of last platinum administration.

The vaccination phase will include 6 administrations of the study drug at 4-week intervals. After vaccination, patients will be monitored for tumor response (if measurable tumor was present at baseline) and for relapse or progression during an 18-month follow-up after completion of vaccine treatment.

The total duration of the study will be 2 years. Assessment for tumor response, disease progression and recurrence will be conducted every 12 weeks from the end of treatment until documented disease progression.

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 recurrent platinum sensitive, non-mucinous ovarian, fallopian tube or primary peritoneal cancer.

Patients enrolled will have received two or more previous platinum-containing regimen. Patients must be determined as platinum sensitive after completion of their penultimate platinum therapy prior to enrollment on this study. Platinum sensitivity is determined as >6 months and <24 months after completion of the patient's final platinum dose. In addition the patients will have demonstrated a tumor response or stable disease upon their last platinum-containing regimen (per RECIST 1.1 and/or CA-125 GCIG criteria) prior to enrolment in this study.

Following consent the patient eligibility will be confirmed. Patients will need to start treatment with study drug within 8 weeks of their last dose of a chemotherapeutic agent of the platinum-containing regimen.

Following randomization, patients will be administered TPIV200 with GM-CSF adjuvant or GM-CSF control alone. Patients will have tumor assessments done every 12 weeks ± 1 week for up to 2 years, until objective disease progression according to RECIST 1.1 or the patient withdraws consent.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Platinum Sensitive Ovarian Cancer

Intervention

FRα peptide plus Adjuvant (GM-CSF), Adjuvant (GM-CSF) Alone

Status

Not yet recruiting

Source

Tapimmune Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-12-01T16:08:21-0500

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