The purpose of this research study is to see if the study drug Belzutifan is effective and safe for participants with clear cell gynecologic malignancy, including but not limited to, ovarian cancer, endometrial cancer, cervical cancer, vaginal cancer, vulvar cancer, or endometriosis-related cancer.
The name of the study drug involved in this study is:
\- Belzutifan (a type of Hypoxia-Inducible Factor-2 alpha (HIF-2a) inhibitor)
Participants must have histologically or cytologically confirmed recurrent or persistent clear cell carcinoma of the ovary (CCOC) or clear cell carcinoma of other gynecologic origin (e.g., endometrial, cervical, vaginal, vulvar, endometriosis-related). If mixed histology, then ≥50% clear cell component.
Participants must have measurable disease, defined as at least one lesion that can be accurately measured per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
Participants must have received at least one prior platinum-based chemotherapeutic regimen for primary management of disease.
Prior bevacizumab is allowed.
Prior use of Belzutifan or another HIF-2a inhibitor.
Pulse oximeter reading <92% at rest, or
Requires intermittent supplemental oxygen, or
Requires chronic supplemental oxygen
Dana-Farber Cancer Institute
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator