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No longer recruiting (closed or complete)Last updated: 7 July 2025

LITESPARK-024: The purpose of this study is to evaluate the efficacy and safety of an oral drug (called belzutifan) when given alone, or in combination with targeted therapy (called palbociclib) in people with advanced clear-cell renal cell carcinoma (ccRCC) who have progressed on prior treatmentA Multicenter, Open-label, Randomized, Phase 1/2 Study of Belzutifan in Combination With Palbociclib Versus Belzutifan Monotherapy in Participants With Advanced Renal Cell Carcinoma

Trial purpose

Medical clipboardCancer treatment

Tumor type

Urinary System Cancers Genitourinary

Age

People18+

Trial acronym

LITESPARK-024

Clinical summary

Summary

This study has two parts.

Part 1 will establish the safety of belzutifan plus palbociclib and determine a recommended dosage of palbociclib for the combination therapy by ascending dose escalation.

Belzutifan will be administered orally once daily as a dose of 120mg. Palbociclib will be given orally according to randomised dose (either 75, 100 or 125mg) for 21 days consecutively followed by 7 days off.

Part 2 will evaluate the efficacy and safety of belzutifan plus palbociclib at the dosage level determined in Part 1. In this Part, participants will be randomly allocated to one of two arms:

In Part 2 Arm 1, participants will receive beltuzifan (120mg) orally once daily and palbociclib orally once daily in a 28-day schedule (21 days on followed by 7 days off). Palbociclib will be administered at a dosage level determined in Part 1.

In Part 2 Arm 2, participants will receive beltuzifan (120mg) orally once daily.

Conditions

This trial is treating people with advanced renal cell carcinoma

Eligibility

Inclusion

  • 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

  • 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

Inclusion

  • Your cancer has not spread to other parts of the body (localised).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Merck Sharp & Dohme LLC

Scientific Title

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

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