NCT03113487

P53MVA and Pembrolizumab in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. To assess response rate (complete responses and partial responses) after treatment with p53MVA and pembrolizumab. SECONDARY OBJECTIVE: I. To assess median progression free survival (PFS), clinical benefit (complete response, partial response lasting \> 6 months), overall survival (OS), safety and tolerability. EXPLORATORY OBJECTIVE: I. Evaluate if the CD8+ T cell signal exceeds that detected in the single agent p53MVA trial. OUTLINE: This is a dose-escalation study of modified vaccinia virus ankara vaccine expressing p53. Patients receive pembrolizumab intravenously (IV) over 30 minutes every 3 weeks and modified vaccinia virus ankara vaccine expressing p53 subcutaneously (SC) every 3 weeks for up to 3 vaccines. Cycles with pembrolizumab repeat every 3 weeks for up to 49 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 1-3 weeks and every 12 weeks thereafter.

Conditions

• Recurrent Platinum-Resistant Fallopian Tube Carcinoma
• Recurrent Platinum-Resistant Ovarian Carcinoma
• Recurrent Platinum-Resistant Primary Peritoneal Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Modified Vaccinia Virus Ankara Vaccine Expressing p53	Given SC
BIOLOGICAL	Pembrolizumab	Given IV

Timeline

• Start date: 2018-02-01
• Primary completion: 2022-08-26
• Completion: 2026-05-04
• First posted: 2017-04-13
• Last updated: 2025-07-20
• Results posted: 2024-10-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study