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NCT03113487 · ClinicalTrials.gov registry record · Phase 2
P53MVA and Pembrolizumab in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
A Phase 2 study of Recurrent Platinum-Resistant Ovarian Carcinoma and Recurrent Platinum-Resistant Fallopian Tube Carcinoma, sponsored by City of Hope Medical Center.
- Active
- Registry status
- Phase 2
- Development phase
- 29
- Enrollment target
- 1
- Study location
NCT03113487: Active Phase 2 study of Recurrent Platinum-Resistant Ovarian Carcinoma and Recurrent Platinum-Resistant Fallopian Tube Carcinoma, sponsored by City of Hope Medical Center.
NCT03113487 is a Phase 2 study of Recurrent Platinum-Resistant Ovarian Carcinoma and Recurrent Platinum-Resistant Fallopian Tube Carcinoma that is active but no longer recruiting, run by City of Hope Medical Center. The registered enrollment target is 29 participants, below the 37-participant average among 5 other Recurrent Platinum-Resistant Ovarian Carcinoma trials with a reported enrollment target (22% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03113487, a Phase 2 study of Recurrent Platinum-Resistant Ovarian Carcinoma and Recurrent Platinum-Resistant Fallopian Tube Carcinoma, is active but no longer recruiting, sponsored by City of Hope Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 29 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well modified vaccinia virus ankara vaccine expressing p53 (p53MVA) and pembrolizumab work in treating patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back (recurrent). Vaccines made from a gene-modified virus may help the body build an effective immune response to kill tumor cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving p53MVA and pembrolizumab together may work better in treating patients with ovarian, primary peritoneal, or fallopian tube cancer.
Primary Outcome
Clinical response was assessed using the modified irRECIST criteria. Complete Response (CR) - Disappearance of all lesions, 2 consecutive observations, ≥ 4 wks apart; Partial Response (PR) - ≥50% decrease in tumor burden from baseline, 2 consecutive observations, ≥ 4 wks apart. Response = CR+PR.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- BIOLOGICAL Modified Vaccinia Virus Ankara Vaccine Expressing p53
Study Locations (1)
California
- City of Hope Medical Center - Duarte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2018-02-01 |
| Est. Completion | 2026-05-04 |
| Phase | Phase 2 |
What the registry record for NCT03113487 still lists
NCT03113487 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 37-participant average among 5 other Recurrent Platinum-Resistant Ovarian Carcinoma trials with a reported enrollment target (22% lower).
The record links to 3 conditions, with Recurrent Platinum-Resistant Ovarian Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT03113487 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03113487 about?
NCT03113487 is a clinical study titled "P53MVA and Pembrolizumab in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer". This phase II trial studies how well modified vaccinia virus ankara vaccine expressing p53 (p53MVA) and pembrolizumab work in treating patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back (recurrent). Vaccines made from a gene-modified virus may help the body build ...
What is the current status of trial NCT03113487?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2018-02-01. Estimated completion is 2026-05-04.
What conditions does trial NCT03113487 study?
This clinical trial studies the following conditions: Recurrent Platinum-Resistant Ovarian Carcinoma, Recurrent Platinum-Resistant Fallopian Tube Carcinoma, Recurrent Platinum-Resistant Primary Peritoneal Carcinoma.
What interventions are being tested in trial NCT03113487?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Modified Vaccinia Virus Ankara Vaccine Expressing p53 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03113487?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03113487 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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