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
Single group
Belzutifan
DrugA Hypoxia-Inducible Factor-2 alpha inhibitor, 40 mg immediate-release tablet, taken orally per protocol.
Objective Response Rate (ORR)
ORR is defined as the percentage of participants achieving complete response (CR) or partial response (PR) on treatment based on RECIST 1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete
Progression Free Survival at 6 months (PFS6)
Progression-Free Survival at 6 Months (PFS6) is defined as the proportion of participants who are alive without disease progression for at least 6 months after initiating study treatment.
Grade 4 Treatment-Related Toxicity Rate
The percentage of participants who experienced a maximum grade 4 treatment-related adverse event based on the Common Toxicity Criteria for Adverse events Version 5.0 (CTCAEv5) as reported on case report forms.
Median Progression Free Survival (PFS)
PFS based on Kaplan Meier method is defined as the duration of time from study entry to documented disease progression (PD) requiring removal from the study or death. Participants alive without PD were censored at the earliest of the date of the last disease evaluation or start of new anticancer therapy.
Median Overall Survival (OS)
Overall Survival (OS) is defined as the time from or registration to death due to any cause, or censored at date last known alive.
Clinical Benefit Rate (CBR)
ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) or stable disease (SD) and last more than 6 months on treatment based on RECIST 1.1 criteria.
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Dana-Farber Cancer Institute
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
