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

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Robert Edwards
Study ID
NCT03734692
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Ovarian Cancer Recurrent

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rintatolimod — DRUG
    200 mg by IP administration over 1-2 hours
  • Pembrolizumab — DRUG
    200 mg will be administered as a 30 minute IV infusion
  • Cisplatin — DRUG
    50mg/m\^2 solution

Study Details

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).

Key Dates

Start date
Jan 28, 2019
Status verified
Jan 2026
Primary completion
Jul 1, 2024
Completion
Jan 10, 2027

Study Design

Enrollment
24 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: cisplatin + rintatolimod + pembrolizumab
    Intraperitoneal (IP) cisplatin 50mg/m\^2 solution with IP rintatolimod 200 mg solution and IV pembrolizumab 200 mg solution.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: At 13 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Magee-Womens Hospital of UPMCPittsburghPennsylvania15213-

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By research site
Magee-Womens Hospital of UPMC· Pittsburgh, PA

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