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LITESPARK-033NCT07227402

A Clinical Study of Belzutifan and Zanzalintinib in People With Recurrent Kidney Cancer Following Adjuvant Therapy (MK-6482-033)

StatusRecruiting
PhasePhase 3
Primary completion (estimated)
Track this trial

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Record History

All 32 versions: 32 with changes below. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 17 words
    • Study completion pushed from Feb 27, 2032 to Mar 21, 2033
    • Study sites: 127 to 129
    • Secondary endpoints: details revised at 12 of 12 entries
  2. Trial sites expanded: 124 → 127 locationsv31
  3. Trial sites expanded: 119 → 124 locationsv30
  4. Study sites: 118 to 119v29
  5. Study sites: 116 to 118v28
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 114 to 116v27
  2. Study sites: 112 to 114v26
  3. Study sites: 111 to 112v25
  1. Trial sites expanded: 108 → 111 locationsv24
  2. Eligibility criteria expanded, about 5 wordsv23
  3. Trial sites expanded: 105 → 108 locationsv22
  4. Study sites: 103 to 105v21
  5. Study sites: 102 to 103v20
  6. Study sites: 100 to 102v19
  7. Trial sites expanded: 91 → 100 locationsv18
  8. Study sites: 90 to 91v17
  9. Study sites: 87 to 90v16
  10. Study sites: 84 to 87v15
  11. Study sites: 83 to 84v14
  12. Study sites: 78 to 83v13
  13. Study sites: 75 to 78v12
  14. Study sites: 69 to 75v11
  15. Study sites: 66 to 69v10
  16. Study sites: 59 to 66v9
  17. Study sites: 53 to 59v8
  18. Study sites: 40 to 53v7
  19. Study sites: 37 to 40v6
  20. Study sites: 34 to 37v5
  21. Study sites: 21 to 34v4
  22. Study sites: 3 to 21v3
  23. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    • Start date changed from estimate of Dec 29, 2025 to Nov 26, 2025
    v2
  24. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Progression Free Survival (PFS)
Timeframe: Up to approximately 73 months
Overall Survival (OS)
Timeframe: Up to approximately 73 months

Secondary (12)

Objective Response Rate (ORR)
Duration of Response (DOR)
Number of Participants Who Experience One or More Adverse Events (AEs)
Number of Participants Who Discontinue Study Treatment due to an AE
Change From Baseline in European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC QLQ-C30) Global Health/Health-Related Quality of Life (HRQoL) Items 29 and 30 Combined Score
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Change From Baseline in EORTC QLC-C30 Physical Functioning Items 1-5 Score
Change From Baseline in EORTC QLQ-C30 Role Functioning Items 6-7 Score
Change From Baseline in Functional Assessment of Cancer Therapy-Kidney Symptom Index-Disease-related Symptoms (FKSI-DRS) Items 1-9 Score
Time From Baseline to First Deterioration in EORTC-QLC-C30 Global Health/HRQoL Score
Time From Baseline to First Deterioration in EORTC-QLC-C30 Physical Functioning Score
Time From Baseline to First Deterioration in EORTC-QLC-C30 Role Functioning Score
Time From Baseline to First Deterioration in FKSI-DRS Score

Arms and interventions

Belzutifan plus ZanzalintinibExperimental

Participants will receive belzutifan orally once daily (QD) PLUS zanzalintinib orally QD until one of the reasons for discontinuation of study intervention are met.

CabozantinibActive comparator

Participants will receive cabozantinib orally QD until one of the reasons for discontinuation of study intervention are met.

Drugs: Belzutifan, Zanzalintinib, Cabozantinib

Sites

129 sites in 24 countries

Italy 14, France 11, Germany 11, Spain 11, United States 11, Argentina 9, Poland 8, Czechia 7, South Korea 6, Brazil 5, Mexico 5, Belgium 4, Taiwan 4, Chile 3, Croatia 3, Denmark 3, Greece 3, Austria 2, Hong Kong 2, Ireland 2, Singapore 2, Australia 1, Saudi Arabia 1, United Kingdom 1