Clinical trial for Ovarian Cancer
Official title Belzutifan in Recurrent Clear Cell Carcinoma of Gynecologic Origin
ClinicalTrials.gov ID: NCT06677190
What this study is testing
What is Belzutifan?
Belzutifan is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for ovarian cancer.
Also referred to as MK-6482, PT2977.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Participants must have histologically or cytologically confirmed recurrent or persistent clear cell carcinoma of the ovary (CCOC) or clear cell...
- Participants must have measurable disease, defined as at least one lesion that can be accurately measured per Response Evaluation Criteria in Solid...
- 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.
You likely can't join 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...
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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).
- Participants must meet the following organ and marrow function as defined below:
- Absolute neutrophil count ≥ 1,500/mcL
- Hemoglobin ≥ 10.0 g/dL (without use of erythropoietin; without packed red blood cell (RBC) transfusion within preceding 2 weeks)
- Platelets ≥ 100,000/mcL
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) OR direct bilirubin ≤ ULN for participants with total bilirubin levels \> 1.5 ULN
- AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional upper limit of normal (ULN) (in the absence of liver metastases) or ≤ 5 x institutional ULN (in the presence of liver metastases)
- Creatinine ≤ 1.5 x institutional upper limit of normal (ULN) OR estimated creatinine clearance (CrCl) by the Cockcroft-Gault formula ≥51mL/min if creatinine \> 1.5 x institutional ULN or institutional standard method
- INR OR PT and PTT ≤1.5 × institutional ULN unless participant is receiving anticoagulant therapy and PT/INR or PTT are within therapeutic range of that anticoagulation
- Participants with known brain metastases are eligible if they have completed primary CNS-directed therapy (such as surgical resection or radiotherapy) and if they have remained clinically stable, asymptomatic...
- Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the Belzutifan, as determined after...
- Archival tumor tissue must be available as 17 (15 unstained + 2 H\&E) freshly serially cut slides from formalin-fixed, paraffin-embedded (FFPE) tissue blocks. The most recent available tissue is preferred to archived...
- The effects of Belzutifan on the developing human fetus are unknown. For this reason, women of child-bearing potential\ must have a negative serum or urine pregnancy test at the Screening and Cycle 1 Day 1 visits. A...
- Post-menopausal, defined as amenorrheic for at least 12 consecutive months within the appropriate age group and without an alternative medical cause OR
- Surgically sterilized (i.e. bilateral oophorectomy, bilateral tubal ligation or salpingectomy, or total hysterectomy)
- Ability to swallow orally administered medications.
- Ability to understand and the willingness to sign a written informed consent document.
What rules you out
- 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...
- Use of herbal supplements, including but not limited to: cannabis, St. John's wort, gingko biloba, ginseng, saw palmetto, and ephedra. Herbal supplements must be stopped at least 1 week prior to beginning study...
- Participants who are known to require concomitant therapy with moderate or strong CYP3A4 inducers. Due to potential drug interactions, concomitant use of these medications is not permitted for the duration of treatment...
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention. Note: Participants who have...
- Participants who have AEs due to previous anticancer therapies must have recovered to
- Grade 1 or baseline with the exception of alopecia. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have
- Grade 2 neuropathy are eligible.
- Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines are allowed. Note: Any licensed COVID-19 vaccine (including for Emergency Use) in a...
- Major surgical procedures within 4 weeks of beginning study treatment are not allowed. Minor surgical procedures (with the exception of port placement) within 1 week of beginning study treatment are not allowed.
- Any gastrointestinal disorder that would interfere with the passage or absorption of oral medications. Participants must be able to swallow oral medications. Participants with an enteric tube (e.g., gastrostomy or...
- Participants with significant cardiovascular impairment, including uncontrolled hypertension, congestive heart failure of New York Heart Association Grade II or above, unstable angina, myocardial infarction within the...
- Has moderate to severe hepatic impairment (Child-Pugh B or C).
- Has received colony-stimulating factors (e.g., G-CSF, GM-CSF, or recombinant EPO) ≤28 days prior to the first dose of study intervention.
- Has a diagnosis of immunodeficiency.
- Is known to be positive for Human Immunodeficiency Virus (HIV). people with HIV, including those on antiretroviral therapy, are excluded due to risk of immunodeficiency and risk of overlapping toxicity.
- Is known to be positive for Hepatitis B virus (HBV) or Hepatitis C virus (HCV). Participants are eligible if they have a history of HCV infection that has been treated and cured, with an undetectable viral load.
- Participants with uncontrolled intercurrent illness, including but not limited to active infection and serious non-healing wounds or ulcers.
- Participants with psychiatric illness/social situations that would limit compliance with study requirements.
- Participants with a history of allergic reactions or hypersensitivity attributed to compounds of similar chemical or biological composition to belzutifan.
- Pregnant women are excluded from this study. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with belzutifan, breastfeeding participants are...
- History or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of...
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.