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)
Summary
Researchers are looking for more ways to treat advanced renal cell carcinoma (RCC) that is recurrent. Researchers want to learn if recurrent advanced renal cell carcinoma (RCC) responds (gets smaller or goes away) after treatment with belzutifan (MK-6482) and zanzalintinib compared to cabozantinib. The goal of this study is to learn if: People who take belzutifan and zanzalintinib live longer overall and without the cancer getting worse than people who take cabozantinib.
Arms & interventions
- DrugBelzutifan
Administered orally QD
- DrugZanzalintinib
Administered orally QD
- DrugCabozantinib
Administered orally QD
Outcome measures
Primary
Progression Free Survival (PFS)
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. PD will be assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented.
Time frame: Up to approximately 73 months
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Time frame: Up to approximately 73 months
Secondary
Objective Response Rate (ORR)
Time frame: Up to approximately 73 months
Duration of Response (DOR)
Time frame: Up to approximately 73 months
Number of Participants Who Experience One or More Adverse Events (AEs)
Time frame: Up to approximately 73 months
Number of Participants Who Discontinue Study Treatment due to an AE
Time frame: Up to approximately 73 months
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
Time frame: Up to approximately 25 months
Change From Baseline in EORTC QLC-C30 Physical Functioning Items 1-5 Score
Time frame: Up to approximately 25 months
Change From Baseline in EORTC QLQ-C30 Role Functioning Items 6-7 Score
Time frame: Up to approximately 25 months
Change From Baseline in Functional Assessment of Cancer Therapy-Kidney Symptom Index-Disease-related Symptoms (FKSI-DRS) Items 1-9 Score
Time frame: Up to approximately 25 months
Time From Baseline to First Deterioration in EORTC-QLC-C30 Global Health/HRQoL Score
Time frame: Up to approximately 25 months
Time From Baseline to First Deterioration in EORTC-QLC-C30 Physical Functioning Score
Time frame: Up to approximately 25 months
Time From Baseline to First Deterioration in EORTC-QLC-C30 Role Functioning Score
Time frame: Up to approximately 25 months
Time From Baseline to First Deterioration in FKSI-DRS Score
Time frame: Up to approximately 25 months
Eligibility criteria
Study locations (1)
Alaska Oncology and Hematology ( Site 0133)
Anchorage, Alaska, 99508