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NCT05468697 · ClinicalTrials.gov registry record · 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)

A Phase 1 study of Renal Cell Carcinoma, sponsored by Merck Sharp & Dohme.

Active
Registry status
Phase 1
Development phase
60
Enrollment target
13
Study locations

NCT05468697: Active Phase 1 study of Renal Cell Carcinoma, sponsored by Merck Sharp & Dohme.

NCT05468697 is a Phase 1 study of Renal Cell Carcinoma that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 60 participants, below the 242-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (75% lower). The trial reports 13 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05468697, a Phase 1 study of Renal Cell Carcinoma, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
60 participants
Enrollment target
13
Study locations

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.

Primary Outcome

A DLT consists of one or more of the following toxicities: Grade (Gr) 3 or 4 hypoxia or dyspnea; Gr 3 or 4 nausea, vomiting, or diarrhea if persistent for \>48 hours despite therapy; Gr 3 or 4 cardiovascular, vascular, or thrombotic events; Nonhematologic AE ≥Gr 3 in severity with exceptions; Gr 3 rash that does not resolve within 2 weeks; Gr 3 nonhematologic toxicity if persisting despite optimal medical treatment; Gr 3 or 4 hematologic toxicities; Gr 3 or 4 febrile neutropenia; Gr 3 or 4 nonhe

Conditions Studied

Renal Cell Carcinoma

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
Merck Sharp & Dohme

558 total trials

What the registry record for NCT05468697 still lists

NCT05468697 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 242-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (75% lower).

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.

NCT05468697 lists 13 locations in 8 states (Other, New South Wales, District of Columbia).

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.

What interventions are being tested in trial NCT05468697?

The interventions under investigation include: Belzutifan (DRUG), Palbociclib (DRUG).

Who is sponsoring clinical trial NCT05468697?

This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Renal Cell Carcinoma

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05468697's enrollment target sits among peer trials

60 70th of 121 higher than 48 of 121 other Renal Cell Carcinoma trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Renal Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT05468697, the US trial registry maintained by the National Library of Medicine. NCT05468697 (small enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.