Phase II Study of Belzutifan for Recurrent or Persistent Clear Cell Carcinoma in Female Gynecologic Cancers

What this Trial Is About

Researchers are evaluating the drug Belzutifan in participants with recurrent or persistent clear cell carcinoma of the ovary or other gynecologic cancers, including endometrial, cervical, vaginal, vulvar, or endometriosis-related cancers. This phase II open-label trial focuses on a targeted therapy approach using Belzutifan, a Hypoxia-Inducible Factor-2 alpha inhibitor, which is not yet FDA-approved for these gynecologic cancers but has been approved for other uses. The study aims to determine the effectiveness and safety of Belzutifan in this patient population. Participants will receive Belzutifan orally once daily in 28-day cycles. The study will enroll 15 participants initially for Stage 1, with treatments including baseline visits, imaging every two cycles, and ECGs on day 1 of each cycle. Additional in-clinic visits occur on day 15 of cycles 1 and 2, followed by an end-of-treatment visit and a 30-day post-treatment visit. If early results show promise, 14 more participants will be enrolled for a second stage. Long-term follow-up visits occur every six months for three years. During the trial, participants will undergo screening, regular imaging with CT and MRI scans, ECGs, and blood and urine tests to monitor disease and treatment effects. Researchers will assess objective response rate, progression-free survival at six months, and track treatment-related toxicities over up to three years. Other measurements include median progression-free survival, overall survival, and clinical benefit rate. Participants health and response to Belzutifan will be closely monitored throughout the study.

Belzutifan in Recurrent Clear Cell Carcinoma of Gynecologic Origin