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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 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.
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.
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
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2022-08-10 |
| Est. Completion | 2026-07-21 |
| Phase | Phase 1 |
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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, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 242-participant average among 121 other Renal Cell Carcinoma trials with a reported enrollment target (75% lower). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
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 reports 13 study locations spanning 8 distinct geographic areas - top geographies include 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.
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