PRIMARY OBJECTIVES:
I. Determine the safety of APL-2 (Pegcetacoplan) alone and in combination with pembrolizumab, and APL-2 in combination with both bevacizumab and pembrolizumab in patients with recurrent ovarian cancer with symptomatic malignant effusion II. Effect of therapy on of malignant effusion measured by total volume of effusion drained every 3 weeks (patient diary and/or drained volume).
SECONDARY OBJECTIVES:
I. Determine progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR) and overall survival (OS) II. Changes in quality of life measures during the clinical trial
This is a single center, randomized, Phase 2 clinical trial of APL-2 in combination with Pembrolizumab or in combination with Bevacizumab and Pembrolizumab vs. Bevacizumab alone in patients with recurrent ovarian/fallopian tube/primary peritoneal cancer and persistent malignant effusions.
A safety-lead in cohort of 3-5 patients, (patients will receive APL-2 alone for 2 weeks prior to adding pembrolizumab or pembrolizumab and bevacizumab) will be recruited to assess the safety of APL-2 alone, determine PK/PD levels is serum and malignant effusion and to test the short-term single-agent APL-2 effects on malignant effusion. If no concerning treatment limiting toxicity signal is seen, the randomized expansion cohorts (2B) are allowed to start. Patients will be randomized to 1 of 3 cohorts (2 experimental arms and 1 standard of care control arm).
COHORT 2B-1: APL-2 (Pegcetacoplan) and pembrolizumab (experimental arm)
COHORT 2B-2: Pegcetacoplan, pembrolizumab and bevacizumab (experimental arm)
COHORT 2B-3: Bevacizumab only (control arm)
Treatment repeats every 3 weeks and treatment will continue until disease progression, patient withdrawal or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and then every 12 weeks thereafter up to 3 years.
Source: View full study details on ClinicalTrials.gov
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