Actively Recruiting
Belzutifan in Recurrent Clear Cell Carcinoma of Gynecologic Origin
Led by Dana-Farber Cancer Institute · Updated on 2025-11-05
32
Participants Needed
2
Research Sites
236 weeks
Total Duration
On this page
Sponsors
D
Dana-Farber Cancer Institute
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Belzutifan in Recurrent Clear Cell Carcinoma of Gynecologic Origin
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have confirmed recurrent or persistent clear cell carcinoma of the ovary or other gynecologic origin, with at least 50% clear cell component if mixed histology.
- Participants must have at least one measurable tumor lesion.
- Participants must have received at least one prior platinum-based chemotherapy regimen.
- Prior bevacizumab and immunotherapy use are allowed.
- Unlimited prior treatments for recurrent or persistent disease are allowed.
- Participants must be 18 years or older.
- ECOG performance status must be 0 or 1.
- Adequate organ and marrow function as defined by specific blood counts and laboratory values.
- Participants with stable brain metastases after treatment may be eligible.
- Participants with other prior or concurrent malignancies may be eligible after discussion.
- Archival tumor tissue must be available for analysis.
- Women of child-bearing potential must have a negative pregnancy test and agree to use contraception.
- Participants must be able to swallow oral medications.
- Participants must be willing and able to provide informed consent.
You will not qualify if you...
- Prior use of Belzutifan or other HIF-2a inhibitors.
- Oxygen saturation below 92% at rest or need for supplemental oxygen.
- Recent anti-cancer treatment within specified washout periods.
- Recent use of small molecule kinase inhibitors or radiation therapy within specified time frames.
- Use of herbal supplements within one week prior to treatment.
- Need for concurrent moderate or strong CYP3A4 inducers.
- Participation in other investigational studies within 4 weeks prior to treatment.
- Unresolved adverse events from prior cancer therapies above specified grades.
- Recent live or live-attenuated vaccine administration.
- Recent major or minor surgeries within specified time frames.
- Gastrointestinal disorders interfering with oral medication absorption.
- Significant cardiovascular impairments.
- Moderate to severe liver impairment.
- Recent use of colony-stimulating factors.
- Immunodeficiency or HIV infection.
- Active Hepatitis B or C infection unless cured.
- Uncontrolled illnesses or infections.
- Psychiatric or social conditions limiting compliance.
- Allergic reactions to drugs similar to Belzutifan.
- Pregnancy or breastfeeding.
- Any condition or circumstance that could interfere with study participation or results as determined by the investigator.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Actively Recruiting
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
Research Team
P
Panagiotis Konstantinopoulos, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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