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NCT04919629 · ClinicalTrials.gov registry record · Phase 2
APL-2 and Pembrolizumab Versus APL-2, Pembrolizumab and Bevacizumab Versus Bevacizumab Alone for the Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer and Malignant Effusion
A Phase 2 study of Ovarian Endometrioid Adenocarcinoma and Fallopian Tube Endometrioid Adenocarcinoma, sponsored by Roswell Park Cancer Institute.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT04919629: Recruiting Phase 2 study of Ovarian Endometrioid Adenocarcinoma and Fallopian Tube Endometrioid Adenocarcinoma, sponsored by Roswell Park Cancer Institute.
NCT04919629 is a Phase 2 study of Ovarian Endometrioid Adenocarcinoma and Fallopian Tube Endometrioid Adenocarcinoma that is actively recruiting participants, run by Roswell Park Cancer Institute. The registered enrollment target is 60 participants, below the 298-participant average among 15 other Ovarian Endometrioid Adenocarcinoma trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04919629, a Phase 2 study of Ovarian Endometrioid Adenocarcinoma and Fallopian Tube Endometrioid Adenocarcinoma, is actively recruiting participants, sponsored by Roswell Park Cancer Institute.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies the effect of APL-2 when given in combination with either pembrolizumab or pembrolizumab and bevacizumab compared with bevacizumab alone in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back (recurrent) and a buildup of fluid and cancer cells (malignant effusion). APL-2 may limit tumor progression, decrease malignant effusion production, and improve the immune system's response against cancer cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Bevacizumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Giving APL-2 together with either pembrolizumab or pembrolizumab and bevacizumab may work better in treating patients with ovarian, fallopian tube, or primary peritoneal cancer and malignant effusion compared to bevacizumab alone.
Primary Outcome
Toxicities and adverse events (as per Common Terminology Criteria for Adverse Events version 5.0) will be summarized by cohort and grade using frequencies and relative frequencies.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- PROCEDURE Biospecimen Collection
- PROCEDURE Biopsy
- BIOLOGICAL Bevacizumab
- DRUG Pegcetacoplan
Study Locations (1)
New York
- Roswell Park Cancer Institute - Buffalo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-04-27 |
| Est. Completion | 2028-04-30 |
| Phase | Phase 2 |
What NCT04919629 shows while recruiting
NCT04919629 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 298-participant average among 15 other Ovarian Endometrioid Adenocarcinoma trials with a reported enrollment target (80% lower).
The record links to 10 conditions, with Ovarian Endometrioid Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT04919629 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04919629 about?
NCT04919629 is a clinical study titled "APL-2 and Pembrolizumab Versus APL-2, Pembrolizumab and Bevacizumab Versus Bevacizumab Alone for the Treatment of Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer and Malignant Effusion". This phase II trial studies the effect of APL-2 when given in combination with either pembrolizumab or pembrolizumab and bevacizumab compared with bevacizumab alone in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back (recurrent) and a buildup of fluid a...
What is the current status of trial NCT04919629?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2023-04-27. Estimated completion is 2028-04-30.
What conditions does trial NCT04919629 study?
This clinical trial studies the following conditions: Ovarian Endometrioid Adenocarcinoma, Fallopian Tube Endometrioid Adenocarcinoma, Fallopian Tube Serous Adenocarcinoma, Ovarian Serous Adenocarcinoma, Ovarian Clear Cell Adenocarcinoma.
What interventions are being tested in trial NCT04919629?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Biospecimen Collection (PROCEDURE), Biopsy (PROCEDURE), Bevacizumab (BIOLOGICAL), Pegcetacoplan (DRUG).
Who is sponsoring clinical trial NCT04919629?
This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04919629 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04919629's enrollment target sits among peer trials
60 9th of 15 higher than 7 of 15 other Ovarian Endometrioid Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ovarian Endometrioid Adenocarcinoma 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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