West Cancer Center

Renal Cell: Metastatic: 3rd or 4th line: LITESPARK-034

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)

Title

Merck MK-6482-034

Study Title

Site Link

NCT07489495

Malignancy

Renal cell carcinoma, Kidney cancer, RCC

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

3rd or 4th line

Investigational Agent

Zanzilitimab

Drug Class

multi-target TKI

Brad Somer, MD

Sponsor

Merck Sharp & Dohme Corp

Phase

Phase 3

Status

Open to Enrollment

Key Eligibility Criteria

Key Eligibility Criteria Details

Histologically confirmed diagnosis of unresectable advanced renal cell carcinoma (RCC) with a clear cell component (with or without sarcomatoid features)
Must have received both a PD-1/L1 inhibitor and a VEGF TKI either sequentially or in combination
Measurable disease
No more than 3 prior systemic regimens including only one PD-1/L1 regimen
LVEF >50%
No interstitial lung disease/pneumonitis
No HIV/HBV/HCV
No history of solid organ transplant

Objective

Primary
- PFS
- OS
Secondary
- ORR
- DOR
- Safety
- QOL

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

RCC with a clear cell component

Dosing Frequency

Control Agents

Study Protocol

Randomized

Yes