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A clinical study of belzutifan for treatment of kidney cancer (MK-6482-013)
EU CTIS ID: 2022-502123-21-00
What this study is testing
To compare the 120 mg once daily (QD) dose and 200 mg QD dose of belzutifan with respect to objective response rate (ORR) based on Response Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Has a histologically confirmed diagnosis of locally advanced/metastatic renal cell carcinoma (RCC) with clear cell component
- Can submit an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
- Has experienced disease progression on or after systemic treatment with an anti-programmed cell death 1 (PD-1)/Ligand 1 (L1) therapy for locally advanced or metastatic RCC
- Has received no more than 3 prior systemic regimens for locally advanced or metastatic RCC
- Has recovered from all AEs due to previous therapies to ≤Grade 1 or baseline, with the exception of ≤Grade 2 neuropathy or endocrine-related AEs ≤Grade 2 requiring treatment or hormone replacement
You likely can't join if
- Has hypoxia (a pulse oximeter reading <92% at rest), requires intermittent supplemental oxygen, or requires chronic supplemental oxygen
- Has an active infection requiring systemic therapy
- Has active tuberculosis (TB)
- Has a diagnosis of immunodeficiency
- Has a known history of human immunodeficiency virus (HIV) infection
- Has a known history of hepatitis B (HBV) or known active hepatitis C (HCV) infection
See the full eligibility criteria
- Has a histologically confirmed diagnosis of locally advanced/metastatic renal cell carcinoma (RCC) with clear cell component
- Can submit an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
- Has experienced disease progression on or after systemic treatment with an anti-programmed cell death 1 (PD-1)/Ligand 1 (L1) therapy for locally advanced or metastatic RCC
- Has received no more than 3 prior systemic regimens for locally advanced or metastatic RCC
- Has recovered from all AEs due to previous therapies to ≤Grade 1 or baseline, with the exception of ≤Grade 2 neuropathy or endocrine-related AEs ≤Grade 2 requiring treatment or hormone replacement
- Has hypoxia (a pulse oximeter reading <92% at rest), requires intermittent supplemental oxygen, or requires chronic supplemental oxygen
- Has an active infection requiring systemic therapy
- Has active tuberculosis (TB)
- Has a diagnosis of immunodeficiency
- Has a known history of human immunodeficiency virus (HIV) infection
- Has a known history of hepatitis B (HBV) or known active hepatitis C (HCV) infection
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ [e.g., breast carcinoma, cervical cancer in situ] that have undergone potentially curative therapy
- Has known CNS metastases and/or carcinomatous meningitis
- Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction ≤6 months from Day 1 of study drug administration or New York Heart Association Class III or IV congestive heart failure
- Has moderate to severe hepatic impairment (Child-Pugh B or C)
- Has received any type of small molecule kinase inhibitor (including investigational kinase inhibitor) ≤2 weeks before randomization
- Has received any type of systemic anticancer antibody (including investigational antibody) ≤4 weeks before randomization
- Has received prior radiotherapy ≤2 weeks prior to first dose of study intervention. Participants must have recovered from all radiation-related toxicities and not require corticosteroids
- Has had major surgery ≤3 weeks prior to first dose of study intervention
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- Australia
- Russian Federation
- United Kingdom
- 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 all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; Australia; Russian Federation; United Kingdom; 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 EU CTIS; the study team decides eligibility.