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NCT04739800 · ClinicalTrials.gov registry record · Phase 2
Comparison of Standard of Care Treatment With a Triplet Combination of Targeted Immunotherapeutic Agents
A Phase 2 study of Fallopian Tube Mucinous Adenocarcinoma and Ovarian Seromucinous Carcinoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 20
- Study locations
NCT04739800: Active Phase 2 study of Fallopian Tube Mucinous Adenocarcinoma and Ovarian Seromucinous Carcinoma, sponsored by National Cancer Institute (NCI).
NCT04739800 is a Phase 2 study of Fallopian Tube Mucinous Adenocarcinoma and Ovarian Seromucinous Carcinoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 120 participants, below the 625-participant average among 6 other Fallopian Tube Mucinous Adenocarcinoma trials with a reported enrollment target (81% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04739800, a Phase 2 study of Fallopian Tube Mucinous Adenocarcinoma and Ovarian Seromucinous Carcinoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial studies the possible benefits of treatment with different combinations of the drugs durvalumab, olaparib and cediranib vs. the usual treatment in patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back after a period of improvement with platinum therapy (recurrent platinum resistant). Usual treatment is the type of treatment most patients with this condition receive if they are not part of a clinical study. Combination therapies studied in this trial include MEDI4736 (durvalumab) plus olaparib and cediranib, durvalumab and cediranib, or olaparib and cediranib. Monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumors cells to grow and spread. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy. Cediranib may stop the growth of tumor cells by blocking VEGF (an enzyme). needed for cell growth. Giving different combinations of durvalumab, olaparib and cediranib may work better in increasing the duration of time that the cancer does not progress compared to the usual treatment.
Primary Outcome
The relationship of randomized treatment assignment to progression free survival. The RECIST 1.1 criteria are used for disease progression. Progression is defined as 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 absolute increase of at least 5 mm. (Note: the appearance of one or more
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- BIOLOGICAL Durvalumab
- PROCEDURE Computed Tomography with Contrast
- DRUG Cediranib Maleate
Study Locations (20)
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Anchorage Radiation Therapy Center - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
- Fairbanks Memorial Hospital - Fairbanks
California
- Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
- Sutter Auburn Faith Hospital - Auburn
- Sutter Cancer Centers Radiation Oncology Services-Auburn - Auburn
- Alta Bates Summit Medical Center-Herrick Campus - Berkeley
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park - Cameron Park
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
- University of Arkansas for Medical Sciences - Little Rock
Arizona
- CTCA at Western Regional Medical Center - Goodyear
- Cancer Center at Saint Joseph's - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2021-06-10 |
| Est. Completion | 2026-11-25 |
| Phase | Phase 2 |
What the registry record for NCT04739800 still lists
NCT04739800 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 625-participant average among 6 other Fallopian Tube Mucinous Adenocarcinoma trials with a reported enrollment target (81% lower).
The record links to 10 conditions, with Fallopian Tube Mucinous Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT04739800 names 20 study sites across 4 states, led by Alaska, California, Arkansas.
Frequently Asked Questions
What is clinical trial NCT04739800 about?
NCT04739800 is a clinical study titled "Comparison of Standard of Care Treatment With a Triplet Combination of Targeted Immunotherapeutic Agents". This phase II trial studies the possible benefits of treatment with different combinations of the drugs durvalumab, olaparib and cediranib vs. the usual treatment in patients with ovarian, primary peritoneal, or fallopian tube cancer that has come back after a period of improvement with platinum the...
What is the current status of trial NCT04739800?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2021-06-10. Estimated completion is 2026-11-25.
What conditions does trial NCT04739800 study?
This clinical trial studies the following conditions: Fallopian Tube Mucinous Adenocarcinoma, Ovarian Seromucinous Carcinoma, Recurrent Fallopian Tube Endometrioid Adenocarcinoma, Recurrent Fallopian Tube Clear Cell Adenocarcinoma, Platinum-refractory Ovarian Carcinoma.
What interventions are being tested in trial NCT04739800?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Durvalumab (BIOLOGICAL), Computed Tomography with Contrast (PROCEDURE), Cediranib Maleate (DRUG).
Who is sponsoring clinical trial NCT04739800?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04739800 being conducted?
This trial has 20 study locations across Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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