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Phase 1/2 Study of Belzutifan Plus Palbociclib Versus Belzutifan in Advanced Renal Cell Carcinoma (RCC)
EU CTIS ID: 2023-504963-17-00
What this study is testing
1. Part 1: To assess the safety and tolerability, and to establish the recommended Phase 2 dose (RP2D) of belzutifan plus palbociclib 2. Part 2: To evaluate the objective response rate (ORR) as assessed by investigator using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 in each arm
- Phase I and Phase II (Integrated)- Other
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 unresectable Stage IV (per American Joint Committee on Cancer [AJCC], 8th Edition) RCC with clear-cell component
- Has had disease progression on or after having received at least 2 systemic treatments for unresectable Stage IV RCC with prior anti-programmed cell death 1 ligand 1 (PD-1/L1) and a vascular endothelial growth factor-tyrosine kinase inhibitor (VEGF-TKI) in sequence or in combination
- Has measurable disease per RECIST 1.1 as assessed by the investigator and verified by blinded independent central review (BICR)
- Has recovered from all AEs due to previous therapies
You likely can't join if
- Has hypoxia, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen
- Has had major surgery ≤3 weeks prior to first dose of study intervention
- Has received colony-stimulating factors (eg, granulocyte colony-stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor [GM-CSF], or recombinant erythropoietin [EPO]) ≤28 days prior to the first dose of study intervention
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has known central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has clinically significant cardiac disease
See the full eligibility criteria
- Has a histologically confirmed diagnosis of unresectable Stage IV (per American Joint Committee on Cancer [AJCC], 8th Edition) RCC with clear-cell component
- Has had disease progression on or after having received at least 2 systemic treatments for unresectable Stage IV RCC with prior anti-programmed cell death 1 ligand 1 (PD-1/L1) and a vascular endothelial growth factor-tyrosine kinase inhibitor (VEGF-TKI) in sequence or in combination
- Has measurable disease per RECIST 1.1 as assessed by the investigator and verified by blinded independent central review (BICR)
- Has recovered from all AEs due to previous therapies
- Has hypoxia, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen
- Has had major surgery ≤3 weeks prior to first dose of study intervention
- Has received colony-stimulating factors (eg, granulocyte colony-stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor [GM-CSF], or recombinant erythropoietin [EPO]) ≤28 days prior to the first dose of study intervention
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has known central nervous system (CNS) metastases and/or carcinomatous meningitis
- Has clinically significant cardiac disease
- Has moderate to severe hepatic impairment
- Has a known history of human immunodeficiency virus (HIV) infection
- Has a history of hepatitis B (HBV) or known active hepatitis C (HCV) infection
- Has received prior treatment of belzutifan or palbociclib
- 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
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Australia
- Israel
- Korea, Republic of
- Canada
- Brazil
- United States
- Chile
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Australia; Israel; Korea, Republic of; Canada; Brazil and 2 more location(s). 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.