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Systemic Immune Checkpoint Blockade and Intraperitoneal Chemo-Immunotherapy in Recurrent Ovarian Cancer

NCT03734692 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-02-12

Study results available
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Summary

This is a phase II single arm efficacy/safety trial that will evaluate the effectiveness of combining intensive locoregional intraperitoneal (IP) chemoimmunotherapy of cisplatin with IP rintatolimod (TLR-3 agonist) and IV infusion of the checkpoint inhibitor pembrolizumab (IVP) for patients with recurrent platinum-sensitive ovarian cancer (OC).

Conditions

  • Ovarian Cancer Recurrent

Interventions

DRUG

Rintatolimod

200 mg by IP administration over 1-2 hours

DRUG

Pembrolizumab

200 mg will be administered as a 30 minute IV infusion

DRUG

Cisplatin

50mg/m\^2 solution

Sponsors & Collaborators

Principal Investigators

  • Robert Edwards, MD · UPMC Hillman Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-28
Primary Completion
2024-07-01
Completion
2027-01-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03734692 on ClinicalTrials.gov