A Phase 3, Randomized, Double-blind, Study of Belzutifan + Zanzalintinib Versus Belzutifan + Placebo in Participants with Advanced RCC who have progressed on or after both PD-1/L1 and VEGF-TKI therapies in sequence or in combination (LITESPARK-034)

Conditions

Renal Cell Carcinoma

Brief summary

Progression Free Survival (PFS), Overall Survival (OS)

Detailed description

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 Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score, Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score, Change from Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score, Change From Baseline in Disease Symptoms Using the Functional Assessment of Cancer Therapy-Kidney Symptom Index-Disease-related Symptoms (FKSI-DRS) (Items 1-9) Score, Time to Deterioration (TTD) in EORTC QLQ-C30 Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score, TTD in EORTC QLQ-C30 Physical Functioning (Items 1-5) Score, TTD in EORTC QLQ-C30 Role Functioning (Items 6 and 7) Score, TTD in Disease Symptoms Using the FKSI-DRS (Items 1-9) Score

Related papers

No related papers found yet.

Interventions

DRUGXL092

DRUGPlacebo to Zanzalintinib

DRUGBELZUTIFAN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression Free Survival (PFS), Overall Survival (OS)	—

Secondary

Measure	Time frame
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 Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score, Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score, Change from Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score, Change From Baseline in Disease Symptoms Using the Functional Assessment of Cancer Therapy-Kidney Symptom Index-Disease-related Symptoms (FKSI-DRS) (Items 1-9) Score, Time to Deterioration (TTD) in EORTC QLQ-C30 Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score, TTD in EORTC QLQ-C30 Physical Functioning (Items 1-5) Score, TTD in EORTC QLQ-C30 Role Functioning (Items 6 and 7)	—

Measure

Time frame

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 Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score, Change from Baseline in the EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score, Change from Baseline in the EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score, Change From Baseline in Disease Symptoms Using the Functional Assessment of Cancer Therapy-Kidney Symptom Index-Disease-related Symptoms (FKSI-DRS) (Items 1-9) Score, Time to Deterioration (TTD) in EORTC QLQ-C30 Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score, TTD in EORTC QLQ-C30 Physical Functioning (Items 1-5) Score, TTD in EORTC QLQ-C30 Role Functioning (Items 6 and 7)

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Outcome results

None listed