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

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.

Timeline

Start

2017-07-20

Primary completion

2020-01-15

Completion

2020-01-15

Outcome

Missed primary endpoint

Stopped: “Futility analysis did not support continuation of the trial”

paper TPIV200 was well tolerated but was not associated with improved PFS. PMID 39068739 ↗

release “Marker has elected to suspend the trial because it did not meet the threshold for probability of success based upon the Company's pre-specified criteria.” markertherapeutics.com ↗

Publications

• Gupta A, O'Cearbhaill RE, Block MS, Hamilton E, Konner JA, Knutson KL, Potts J, Garrett G, Kenney RT, Wenham RM; TPIV200 Ovarian Cancer Study Investigators (listed at the end). Vaccination with folate receptor-alpha peptides in patients with ovarian cancer following response to platinum-based therapy: A randomized, multicenter clinical trial. Gynecol Oncol. 2024 Oct;189:90-97. doi: 10.1016/j.ygyno.2024.07.675. Epub 2024 Jul 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	TPIV200	Vaccine	500 ug	Other
Comparator	GM-CSF	Protein / enzyme biologic	125 ug	Other

Indications