drugset / Trial / NCT02933073

Study of Oncoimmunome for the Treatment of Stage III/IV Ovarian Carcinoma

NCT02933073 ↗

Phase 1 Terminated 8 enrolled UConn Health
NaSingle-groupOpen-labelTreatment

Summary

This is a Phase I trial to test the safety and feasibility of OncoImmunome vaccine in stage III/IV ovarian cancer patients. OncoImmunome is a tumor specific vaccine formulation which is predicted to elicit tumor-protective immune responses. A total of 15 patients will be enrolled from the Principal Investigator (PI) clinical practice. These patients will have just successfully completed standard of care surgical debulking with preservation of fresh tumor, chemotherapy treatment and be in documented clinical remission prior to receiving the vaccine. The patients receive 6-monthly doses of the vaccine and are monitored for up to 5 years post vaccination. This is a personalized vaccine, unique to each patient and is the "first in human" use.

Timeline

Start
2016-11
Primary completion
2022-08
Completion
2022-08

Outcome

Outcome not reported

Stopped (Enrollment): “Study recruitment is temporary on hold by the sponsor due to patient recruitment challenges and the ongoing review of the investigational adjuvant.”

Drugs

EvaluationDrugModalityDoseRoute
Subject OncoImmunome Vaccine — —

Indications