A Study of Belzutifan (MK-6482) in Combination With Palbociclib Versus Belzutifan Monotherapy in Participants With Advanced Renal Cell Carcinoma (MK-6482-024/LITESPARK-024) (NCT05468697)
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
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this study is to evaluate the efficacy and safety of belzutifan monotherapy and belzutifan plus palbociclib combination therapy in participants with advanced clear-cell renal cell carcinoma (ccRCC) who experienced disease progression on or after receiving prior therapy. The study will establish the safety of belzutifan plus palbociclib and determine a recommended dosage of palbociclib for the combination therapy by ascending dose escalation.
Who can join: Review the eligibility criteria below.
Location: Georgetown University Medical Center ( Site 1002) — Washington D.C., District of Columbia
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (13 Sites)
- Georgetown University Medical Center ( Site 1002) — Washington D.C., District of Columbia
- University of Chicago Medical Center ( Site 1007) — Chicago, Illinois
- Beth Israel Deaconess Medical Center-Cancer Clinical Trials Office ( Site 1001) — Boston, Massachusetts
- Huntsman Cancer Institute-HCI Clinical Trials Office ( Site 1004) — Salt Lake City, Utah
- Macquarie University-MQ Health Clinical Trials Unit ( Site 2001) — Macquarie University, New South Wales
- Westmead Hospital ( Site 2006) — Westmead, New South Wales
- Frankston Hospital-Oncology and Haematology ( Site 2005) — Frankston, Victoria
- One Clinical Research ( Site 2008) — Nedlands, Western Australia
- Emek Medical Center-oncology ( Site 3003) — Afula,
- Rambam Health Care Campus-Oncology ( Site 3000) — Haifa,
- Shaare Zedek Medical Center-Oncology ( Site 3002) — Jerusalem,
- Rabin Medical Center-Oncology ( Site 3004) — Petah Tikva,
- Sourasky Medical Center ( Site 3005) — Tel Aviv,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Renal Cell Carcinoma
- A Study of Immune Checkpoint Inhibitor Combinations With Axitinib in Participants With Untreated Locally Advanced Unresectable or Metastatic Renal Cell Carcinoma — Birmingham, Alabama
- 89Zr-DFO-Atezolizumab ImmunoPET/CT in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma — Dallas, Texas
- Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma — Stanford, California
- Follow-up After Metastasectomy in Patients With Kidney Cancer — Houston, Texas
- Study of Cabozantinib in Combination With Nivolumab and Ipilimumab in Patients With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma — La Jolla, California
- A Study of HFB200603 as a Single Agent and in Combination With Tislelizumab in Adult Patients With Advanced Solid Tumors — Los Angeles, California
Explore by condition: All Renal Cell Carcinoma clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.