Clinical Trial

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

Recruiting Phase 2
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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.
Protocol Amendment History 26 amendments
This ClinicalTrials.gov record has been amended 26 times since 2021-06-02; most recent amendment 2026-03-19.
Status change: Not Yet Recruiting → Recruiting 2023-02-17
Trial Details
NCT Number NCT04919629
Lead Sponsor Roswell Park Cancer Institute
Collaborators: National Cancer Institute (NCI)
Conditions Fallopian Tube Carcinosarcoma, Fallopian Tube Clear Cell Adenocarcinoma, Fallopian Tube Endometrioid Adenocarcinoma, Fallopian Tube Serous Adenocarcinoma, Ovarian Carcinosarcoma, Ovarian Clear Cell Adenocarcinoma, Ovarian Endometrioid Adenocarcinoma, Ovarian Serous Adenocarcinoma +7 more
Enrollment 60 participants
Start Date 2023-04-27
Primary Completion 2028-04-30 (estimated)
Study Completion 2028-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-03-23