RecruitingOvarian CancerOvarian CarcinomaEndometrial Cancer
Belzutifan in Recurrent Clear Cell Carcinoma of Gynecologic Origin
Eligible age
18+ yrs
Accepts
Women
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
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About this study
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)
Sponsor: Dana-Farber Cancer Institute
You may qualify if…
- ✓ 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 immunotherapy is allowed.
- ✓ Unlimited prior lines for the treatment of recurrent or persistent disease are allowed.
- ✓ Age ≥18 years. Because no dosing or adverse event data are currently available on the use of Belzutifan in participants \<18 years of age, children are excluded from this study.
- ✓ ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1 (Karnofsky performance scale ≥70%, see Appendix A).
You may not qualify if…
- ✕ Prior use of Belzutifan or another HIF-2a inhibitor.
- ✕ Participant has any of the following:
- ✕ Pulse oximeter reading \<92% at rest, or
- ✕ Requires intermittent supplemental oxygen, or
- ✕ Requires chronic supplemental oxygen
- ✕ Anti-cancer treatment (chemotherapy, radiotherapy, or other investigational therapy) within 4 weeks prior to entering the study (6 weeks prior to study entry for nitrosoureas or mitomycin C).
- ✕ Prior small molecule kinase inhibitor (including investigational kinase inhibitor) ≤ 2 weeks prior to entering the study.
- ✕ Prior radiation therapy within 2 weeks of start of study drugs. Participants must have recovered from all radiation-related toxicities and must not require steroids. Participants must not have had radiation pneumonitis. Palliative radiation (≤2 weeks of radiotherapy) to non-CNS (central nervous system) disease is permitted, provided there is at least a 1-week washout prior to start of study drugs.
Where it's recruiting
Massachusetts
Boston
Source: ClinicalTrials.gov · NCT06677190 · last updated 2025-11-05