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NCT03734692 · ClinicalTrials.gov registry record · Phase 1
Systemic Immune Checkpoint Blockade and Intraperitoneal Chemo-Immunotherapy in Recurrent Ovarian Cancer
A Phase 1 study of Ovarian Cancer Recurrent, sponsored by Robert Edwards.
- Active
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT03734692: Active Phase 1 study of Ovarian Cancer Recurrent, sponsored by Robert Edwards.
NCT03734692 is a Phase 1 study of Ovarian Cancer Recurrent that is active but no longer recruiting, run by Robert Edwards. The registered enrollment target is 24 participants, below the 131-participant average among 4 other Ovarian Cancer Recurrent trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03734692, a Phase 1 study of Ovarian Cancer Recurrent, is active but no longer recruiting, sponsored by Robert Edwards.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study 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).
Primary Outcome
The proportion of subjects with the best response of complete response (CR), or partial response (PR) per Response Evaluation Criteria for Solid Tumors (RECIST 1.1). Per RECIST 1.1 , CR is defined as all target lesions gone; PR is defined as a \> 30% decrease in size of lesion from baseline.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Cisplatin
- DRUG Rintatolimod
Study Locations (1)
Pennsylvania
- Magee-Womens Hospital of UPMC - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2019-01-28 |
| Est. Completion | 2027-01-10 |
| Phase | Phase 1 |
What the registry record for NCT03734692 still lists
NCT03734692 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 131-participant average among 4 other Ovarian Cancer Recurrent trials with a reported enrollment target (82% lower).
The record links to 1 condition, with Ovarian Cancer Recurrent appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT03734692 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03734692 about?
NCT03734692 is a clinical study titled "Systemic Immune Checkpoint Blockade and Intraperitoneal Chemo-Immunotherapy in Recurrent Ovarian Cancer". 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 rec...
What is the current status of trial NCT03734692?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2019-01-28. Estimated completion is 2027-01-10.
What conditions does trial NCT03734692 study?
This clinical trial studies the following conditions: Ovarian Cancer Recurrent.
What interventions are being tested in trial NCT03734692?
The interventions under investigation include: Pembrolizumab (DRUG), Cisplatin (DRUG), Rintatolimod (DRUG).
Who is sponsoring clinical trial NCT03734692?
This trial is sponsored by Robert Edwards, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03734692 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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