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ACTIVE NOT RECRUITING Phase 1

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 · View on ClinicalTrials.gov ↗

Study Summary

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.

Conditions Studied

Interventions

  • DRUG Belzutifan
  • DRUG Palbociclib

Study Locations (13)

Other

  • 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

New South Wales

  • Macquarie University-MQ Health Clinical Trials Unit ( Site 2001) — Macquarie University
  • Westmead Hospital ( Site 2006) — Westmead

District of Columbia

  • Georgetown University Medical Center ( Site 1002) — Washington D.C.

Illinois

  • University of Chicago Medical Center ( Site 1007) — Chicago

Massachusetts

  • Beth Israel Deaconess Medical Center-Cancer Clinical Trials Office ( Site 1001) — Boston

Utah

  • Huntsman Cancer Institute-HCI Clinical Trials Office ( Site 1004) — Salt Lake City

Victoria

  • Frankston Hospital-Oncology and Haematology ( Site 2005) — Frankston

Western Australia

  • One Clinical Research ( Site 2008) — Nedlands

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2022-08-10
Est. Completion 2026-07-21
Phase Phase 1

Sponsor

Merck Sharp & Dohme

741 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05468697

The ClinicalTrials.gov registry entry for NCT05468697 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Renal Cell Carcinoma appearing as the primary indexed condition, and to 2 interventions — of which Belzutifan is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05468697 reports 13 study locations spanning 8 distinct geographic areas — top geographies include Other, New South Wales, District of Columbia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05468697 about?

NCT05468697 is a clinical study titled "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)". 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...

What is the current status of trial NCT05468697?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2022-08-10. Estimated completion is 2026-07-21.

What conditions does trial NCT05468697 study?

This clinical trial studies the following conditions: Renal Cell Carcinoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05468697?

The interventions under investigation include: Belzutifan (DRUG), Palbociclib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05468697?

This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05468697 being conducted?

This trial has 13 study locations across District of Columbia, Illinois, Massachusetts, Utah, New South Wales. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial