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NCT04034927 · ClinicalTrials.gov registry record · Phase 2
Testing the Addition of an Immunotherapy Drug, Tremelimumab, to the PARP Inhibition Drug, Olaparib, for Recurrent Ovarian, Fallopian Tube or Peritoneal Cancer
A Phase 2 study of Recurrent Fallopian Tube Carcinoma and Ovarian High Grade Serous Adenocarcinoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 61
- Enrollment target
- 20
- Study locations
NCT04034927: Active Phase 2 study of Recurrent Fallopian Tube Carcinoma and Ovarian High Grade Serous Adenocarcinoma, sponsored by National Cancer Institute (NCI).
NCT04034927 is a Phase 2 study of Recurrent Fallopian Tube Carcinoma and Ovarian High Grade Serous Adenocarcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 61 participants, below the 227-participant average among 35 other Recurrent Fallopian Tube Carcinoma trials with a reported enrollment target (73% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04034927, a Phase 2 study of Recurrent Fallopian Tube Carcinoma and Ovarian High Grade Serous Adenocarcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 61 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial studies how well olaparib with or without tremelimumab works in treating patients with ovarian, fallopian tube, or peritoneal cancer that has come back (recurrent). PARPs are proteins that help repair deoxyribonucleic acid (DNA) mutations. PARP inhibitors, such as olaparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Immunotherapy with monoclonal antibodies, such as tremelimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving olaparib and tremelimumab together may work better than olaparib alone in treating patients with ovarian, fallopian tube, or peritoneal cancer.
Primary Outcome
The count of participants who have progressed or died (death due to any cause). Progression is defined by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Summary of RECIST 1.1 criteria for progression for this trial: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an a
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- DRUG Olaparib
- BIOLOGICAL Tremelimumab
Study Locations (20)
Ohio
- UHHS-Chagrin Highlands Medical Center - Beachwood
- Case Western Reserve University - Cleveland
- Cleveland Clinic Foundation - Cleveland
- Ohio State University Comprehensive Cancer Center - Columbus
Pennsylvania
- Thomas Jefferson University Hospital - Philadelphia
- University of Pittsburgh Cancer Institute (UPCI) - Pittsburgh
Virginia
- University of Virginia Cancer Center - Charlottesville
- VCU Massey Comprehensive Cancer Center - Richmond
California
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
Colorado
- UCHealth University of Colorado Hospital - Aurora
Connecticut
- Hartford Hospital - Hartford
Georgia
- Augusta University Medical Center - Augusta
Illinois
- University of Chicago Comprehensive Cancer Center - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2019-12-04 |
| Est. Completion | 2027-02-21 |
| Phase | Phase 2 |
What the registry record for NCT04034927 still lists
NCT04034927 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 227-participant average among 35 other Recurrent Fallopian Tube Carcinoma trials with a reported enrollment target (73% lower).
The record links to 10 conditions, with Recurrent Fallopian Tube Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT04034927 names 20 study sites across 15 states, led by Ohio, Pennsylvania, Virginia.
Frequently Asked Questions
What is clinical trial NCT04034927 about?
NCT04034927 is a clinical study titled "Testing the Addition of an Immunotherapy Drug, Tremelimumab, to the PARP Inhibition Drug, Olaparib, for Recurrent Ovarian, Fallopian Tube or Peritoneal Cancer". This phase II trial studies how well olaparib with or without tremelimumab works in treating patients with ovarian, fallopian tube, or peritoneal cancer that has come back (recurrent). PARPs are proteins that help repair deoxyribonucleic acid (DNA) mutations. PARP inhibitors, such as olaparib, can k...
What is the current status of trial NCT04034927?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 61 participants. The study started on 2019-12-04. Estimated completion is 2027-02-21.
What conditions does trial NCT04034927 study?
This clinical trial studies the following conditions: Recurrent Fallopian Tube Carcinoma, Ovarian High Grade Serous Adenocarcinoma, Fallopian Tube High Grade Serous Adenocarcinoma, Primary Peritoneal High Grade Serous Adenocarcinoma, Recurrent Fallopian Tube Endometrioid Adenocarcinoma.
What interventions are being tested in trial NCT04034927?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Olaparib (DRUG), Tremelimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04034927?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04034927 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Recurrent Fallopian Tube Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04034927's enrollment target sits among peer trials
61 18th of 35 higher than 18 of 35 other Recurrent Fallopian Tube Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Fallopian Tube Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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