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OncoMatch/Clinical Trials/NCT04919629

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

Is NCT04919629 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Bevacizumab and Pembrolizumab for fallopian tube carcinosarcoma.

Phase 2RecruitingRoswell Park Cancer InstituteNCT04919629Data as of May 2026

Treatment: Bevacizumab · Pegcetacoplan · PembrolizumabThis 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.

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Extracted eligibility criteria

Cancer type

Ovarian Cancer

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: immune checkpoint inhibitor (pembrolizumab)

Exception: not received for 9 weeks prior to enrollment

Patient has not received pembrolizumab or other immune checkpoint inhibitor treatment for 9 weeks prior to enrollment

Cannot have received: investigational drug or device

Exception: not used within 3 weeks of the first dose of treatment

is currently receiving any additional cancer therapy or participating or used an investigational drug or device within 3 weeks of the first dose of treatment

Lab requirements

Blood counts

ANC: >= 1,500/µL; Platelets: >= 75,000/µL; Hemoglobin: >= 9 g/dL or 5.6 mmol/L (within 7 days of assessment)

Kidney function

Creatinine: <= 1.5 X ULN OR measured or calculated creatinine clearance >= 60 mL/min (Cockcroft-Gault Equation) for participant with creatinine levels > 1.5 X institutional ULN. GFR can also be used in place of creatinine or creatinine clearance (CrCl)

Liver function

Total bilirubin: <= 1.5 X ULN OR direct bilirubin <= ULN for participants with total bilirubin levels > 1.5 ULN; AST and ALT: <= 2.5 X ULN OR <= 5 X ULN for participants with liver metastases; Albumin: > 2.5 gm/dL

Cardiac function

No clinically significant cardiovascular disease including: uncontrolled hypertension (systolic >150 mmHg or diastolic >90 mmHg), myocardial infarction or unstable angina within 6 months prior to enrollment, NYHA Grade II or greater congestive heart failure, Grade II or greater peripheral vascular disease, clinically significant peripheral artery disease within 6 months prior to study enrollment

ANC: >= 1,500/µL; Platelets: >= 75,000/µL; Hemoglobin: >= 9 g/dL or 5.6 mmol/L (within 7 days of assessment); Creatinine: <= 1.5 X ULN OR measured or calculated creatinine clearance >= 60 mL/min (Cockcroft-Gault Equation) for participant with creatinine levels > 1.5 X institutional ULN. GFR can also be used in place of creatinine or creatinine clearance (CrCl); Total bilirubin: <= 1.5 X ULN OR direct bilirubin <= ULN for participants with total bilirubin levels > 1.5 ULN; AST and ALT: <= 2.5 X ULN OR <= 5 X ULN for participants with liver metastases; Albumin: > 2.5 gm/dL; INR or PT: <= 1.5 unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants; aPTT: <= 1.5 X ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Roswell Park Cancer Institute · Buffalo, New York

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