RecruitingPhase 2NCT04919629

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

Randomized Phase 2 Trial of APL-2 With Pembrolizumab vs. APL-2 With Pembrolizumab and Bevacizumab vs. Bevacizumab Alone in Patients With Recurrent Ovarian Cancer and Persistent Malignant Effusion

Sponsor

Roswell Park Cancer Institute

Enrollment

60 participants

Start Date

Apr 27, 2023

Study Type

INTERVENTIONAL

Conditions

Recurrent Ovarian Carcinoma Recurrent Fallopian Tube Carcinoma Recurrent Primary Peritoneal Carcinoma Fallopian Tube Carcinosarcoma Primary Peritoneal 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 Primary Peritoneal Clear Cell Adenocarcinoma Primary Peritoneal Endometrioid Adenocarcinoma Primary Peritoneal Serous Adenocarcinoma

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing three different treatment combinations — including two drugs that target the immune system (APL-2 and pembrolizumab) and a drug that blocks blood vessel growth (bevacizumab) — for women with recurrent ovarian, fallopian tube, or peritoneal cancer who have developed fluid buildup in the belly or chest. **You may be eligible if:** - You are 18 or older with recurrent ovarian, fallopian tube, or peritoneal cancer - You have significant fluid buildup in your belly (ascites) or chest (pleural effusion) requiring drainage - You have good overall health (ECOG 0 or 1) - You have not received pembrolizumab or similar immunotherapy in the last 9 weeks - You have a life expectancy of at least 3 months **You may NOT be eligible if:** - You currently have untreated or active brain metastases - You have active autoimmune conditions requiring long-term steroids - You have had a recent heart attack, severe heart disease, or stroke - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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