Evaluating belzutifan with or without palbociclib for advanced kidney cancer
A Multicenter, Open-label, Randomized, Phase 1/2 Study of Belzutifan in Combination With Palbociclib Versus Belzutifan Monotherapy in Participants With Advanced Renal Cell Carcinoma
This study is testing if a new drug called belzutifan, alone or with another drug called palbociclib, can help people with advanced kidney cancer who haven't responded to previous treatments.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Merck Sharp & Dohme LLC Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 13 sites (Washington, District of Columbia and 12 other locations) |
| Trial ID | NCT05468697 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and efficacy of belzutifan alone and in combination with palbociclib in patients with advanced clear-cell renal cell carcinoma who have experienced disease progression after prior treatments. The trial is divided into two parts: the first part focuses on determining the safety and optimal dosage of the combination therapy, while the second part evaluates its effectiveness at the established dosage. Participants will be closely monitored for any adverse effects and treatment responses throughout the study.
Who should consider this trial
Good fit: Ideal candidates are individuals with unresectable Stage IV clear-cell renal cell carcinoma who have progressed after at least two systemic treatments.
Not a fit: Patients with significant hypoxia, active additional malignancies, or central nervous system metastases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for patients with advanced renal cell carcinoma who have limited options after disease progression.
How similar studies have performed: Other studies have shown promising results with similar combination therapies in advanced renal cell carcinoma, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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 Exclusion Criteria: * Has hypoxia, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen * 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 * 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
Where this trial is running
Washington, District of Columbia and 12 other locations
- Georgetown University Medical Center ( Site 1002) — Washington, District of Columbia, United States (Recruiting)
- University of Chicago Medical Center ( Site 1007) — Chicago, Illinois, United States (Recruiting)
- Beth Israel Deaconess Medical Center-Cancer Clinical Trials Office ( Site 1001) — Boston, Massachusetts, United States (Recruiting)
- Huntsman Cancer Institute-HCI Clinical Trials Office ( Site 1004) — Salt Lake City, Utah, United States (Recruiting)
- Macquarie University-MQ Health Clinical Trials Unit ( Site 2001) — Macquarie University, New South Wales, Australia (Recruiting)
- Westmead Hospital ( Site 2006) — Westmead, New South Wales, Australia (Recruiting)
- Frankston Hospital-Oncology and Haematology ( Site 2005) — Frankston, Victoria, Australia (Recruiting)
- One Clinical Research ( Site 2008) — Nedlands, Western Australia, Australia (Recruiting)
- Emek Medical Center-oncology ( Site 3003) — Afula, Israel (Recruiting)
- Rambam Health Care Campus-Oncology ( Site 3000) — Haifa, Israel (Recruiting)
- Shaare Zedek Medical Center-Oncology ( Site 3002) — Jerusalem, Israel (Recruiting)
- Rabin Medical Center-Oncology ( Site 3004) — Petah Tikva, Israel (Recruiting)
- Sourasky Medical Center ( Site 3005) — Tel Aviv, Israel (Recruiting)
Study contacts
- Study coordinator: Toll Free Number
- Email: Trialsites@msd.com
- Phone: 1-888-577-8839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.