Belzutifan in Recurrent Clear Cell Carcinoma of Gynecologic Origin

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT06677190
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Belzutifan — DRUG
    A Hypoxia-Inducible Factor-2 alpha inhibitor, 40 mg immediate-release tablet, taken orally per protocol.

Study Details

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)

Key Dates

Start date
Dec 20, 2024
Status verified
Nov 2025
Primary completion
Dec 30, 2026
Completion
Jun 30, 2029

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Belzutifan
    15 participants will be enrolled for Stage 1 and will complete: * Baseline in-clinic visit * Imaging every 2 cycles * ECG on Day 1 of each cycle * Cycle 1 through End of Treatment: * Day 1 through 28 of 28 day cycle: Predetermined dose of Belzutifan 1x daily. * Day 15 of 28 day cycle: in-clinic visit * Cycle 2 Day 15 of 28 day cycle: in-clinic visit * End of treatment visit with ECG, blood tests, and imaging. * 30 Day post-treatment visit * Long-term follow up: every 6 months for 3 years * If 3 or more participants have objective response OR 2 or more participants are progression-free at 6 months, the study will enroll an additional 14 participants for Stage 2. Otherwise, enrollment will stop if there are less than 3 participants with objective response AND less than 2 participants are progression-free at 6 months.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: ORR expected to be observed up to 3 years. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02215
Panagiotis Konstantinopoulos, MD, PhD
[email protected]
617-632-2334
Panagiotis Konstantinopoulos, MD, PhD (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02215
Panagiotis Konstantinopoulos, MD, PhD
[email protected]
617-632-2334
Panagiotis Konstantinopoulos, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Cervical cancerEndometrial cancerOvarian cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Brigham and Women's Hospital· Boston, MADana-Farber Cancer Institute· Boston, MA

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