Actively Recruiting
A Phase II Trial of Belzutifan for Recurrent or Persistent Clear Cell Carcinoma of the Ovary or Other Gynecologic Cancers
Led by Dana-Farber Cancer Institute · Updated on 2025-11-05
32
Participants Needed
2
Research Sites
130 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
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.
CONDITIONS
Brief Title
Belzutifan in Recurrent Clear Cell Carcinoma of Gynecologic Origin
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female participants aged 18 years or older
- Histologically or cytologically confirmed recurrent or persistent clear cell carcinoma of ovary or other gynecologic origin
- Measurable disease per RECIST v1.1 criteria
- Received at least one prior platinum-based chemotherapy
- ECOG performance status of 0 or 1
- Adequate organ and marrow function as defined by specific blood counts and liver/kidney function
- Stable brain metastases allowed if asymptomatic and stable for 4 weeks
- Archival tumor tissue available for testing
- Women of child-bearing potential must have negative pregnancy test and agree to contraception
- Ability to swallow oral medications and provide informed consent
You will not qualify if you...
- Prior use of Belzutifan or other HIF-2a inhibitors
- Pulse oximeter reading below 92% at rest or need for supplemental oxygen
- Recent anti-cancer treatment within 4 weeks (6 weeks for certain drugs)
- Recent radiation therapy within 2 weeks unless palliative with washout
- Use of herbal supplements within 1 week before treatment
- Use of medications that induce CYP3A4 without substitution
- Participation in other investigational studies within 4 weeks
- Unresolved adverse events from prior therapies above grade 1 except alopecia and some neuropathies
- Live vaccine within 30 days before treatment
- Major surgery within 4 weeks or minor surgery within 1 week before treatment
- Gastrointestinal disorders interfering with oral medication absorption
- Significant cardiovascular impairment
- Moderate to severe liver impairment
- Recent use of colony-stimulating factors within 28 days
- Immunodeficiency or positive HIV status
- Positive for hepatitis B or C unless cured with undetectable viral load
- Uncontrolled illnesses, serious wounds, or psychiatric/social issues limiting compliance
- History of allergic reactions to similar compounds
- Pregnant or breastfeeding women
- Any condition interfering with study participation or safety as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or unacceptable toxicity, up to 3 years
Participants take Belzutifan tablets daily in 28-day cycles and have regular in-clinic visits and tests to monitor their disease and health.
In-clinic visits on Day 1 and Day 15 of cycles 1 and 2, then imaging every 2 cycles, and ECG on Day 1 of each cycle
Duration - Up to 3 years
After treatment ends, participants have a post-treatment visit and regular follow-up visits for up to 3 years to monitor their health and disease status.
1 visit 30 days post-treatment, then follow-up visits every 3 to 6 months for up to 3 years
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
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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