A Phase 3, Randomized, Open-label Study of Belzutifan + Zanzalintinib Versus Cabozantinib in Participants with Advanced RCC who Experienced Disease Recurrence During or After Prior Adjuvant Anti-PD-1/L1 Therapy (LITESPARK-033)

Conditions

Renal Cell Carcinoma

Brief summary

Progression free survival, Overall survival

Detailed description

Objective Response Rate, Duration of Response, Number of participants with ≥1 AE(s), Number of participants who discontinue study therapy due to AE(s), 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) score, Change from baseline in EORTC QLC-C30 physical functioning score, Change from baseline in EORTC QLQ-C30 role functioning score, Change from baseline in Functional Assessment of Cancer Therapy-Kidney Symptom Index-Disease-related Symptoms (FKSI-DRS) 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

Related papers

No related papers found yet.

Interventions

DRUGXL092

DRUGBELZUTIFAN

DRUGCabozantinib Ipsen 20 mg film-coated tablets

DRUGCabozantinib Ipsen 60 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression free survival, Overall survival	—

Secondary

Measure	Time frame
Objective Response Rate, Duration of Response, Number of participants with ≥1 AE(s), Number of participants who discontinue study therapy due to AE(s), 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) score, Change from baseline in EORTC QLC-C30 physical functioning score, Change from baseline in EORTC QLQ-C30 role functioning score, Change from baseline in Functional Assessment of Cancer Therapy-Kidney Symptom Index-Disease-related Symptoms (FKSI-DRS) 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	—

Measure

Time frame

Objective Response Rate, Duration of Response, Number of participants with ≥1 AE(s), Number of participants who discontinue study therapy due to AE(s), 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) score, Change from baseline in EORTC QLC-C30 physical functioning score, Change from baseline in EORTC QLQ-C30 role functioning score, Change from baseline in Functional Assessment of Cancer Therapy-Kidney Symptom Index-Disease-related Symptoms (FKSI-DRS) 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

—

Countries

Austria, Belgium, Croatia, Czechia, Denmark, France, Germany, Greece, Ireland, Italy, Poland, Spain

Outcome results

None listed