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Phase 3 Randomized, Open-Label Study of Zanzalintinib (XL092) With Nivolumab vs Sunitinib in Advanced or Metastatic Non–Clear Cell Renal Cell Carcinoma
THE COMBINATION OF zanzalintinib AND NIVOLUMAB IS NOT APPROVED FOR THE USE UNDER INVESTIGATION IN THIS TRIAL. SAFETY AND EFFICACY HAVE NOT BEEN ESTABLISHED.
Study Overview
Key Eligibility Criteria
Key Endpoints
Participating Sites
Study Overview
Approximately 291 eligible patients with advanced or metastatic nccRCC will be randomly assigned in a 2:1 ratio to zanzalintinib in combination with nivolumab or to sunitinib to evaluate the effect of the combination therapy on PFS and ORR vs sunitinib.
Stratification Factors
Histology (papillary w/o sarcomatoid features vs other subtypes w/o sarcomatoid features vs any histology with sarcomatoid features)
IMDC prognostic score (favorable vs intermediate vs poor)
Key Eligibility Criteria
Unresectable, advanced, or metastatic nccRCC (papillary, unclassified, and translocation subtypes); sarcomatoid features allowed
Measurable disease
No prior systemic anticancer therapy for unresectable locally advanced or metastatic nccRCC
One prior systemic adjuvant therapy, excluding sunitinib, allowed if recurrence ≥6 months after last dose
Key Endpoints
Multiple Primary Endpoints
PFS by BIRC
ORR by BIRC
Secondary Endpoint
OS
Additional Endpoints
DOR by BIRC
PFS, ORR, and DOR by investigator
PROs accessed by FKSI-19 and EQ-5D-5L
BIRC,
Blinded Independent Radiology Committee;
DOR,
duration of response;
EQ-5D-5L,
EuroQol health questionnaire instrument;
FKSI,
Functional Assessment of Cancer Therapy-Kidney Symptom Index;
IMDC,
International Metastatic RCC Database Consortium;
IV,
intravenous; nccRCC, non–clear cell renal cell carcinoma;
ORR,
objective response rate; OS, overall survival; IV,
intravenous;
PFS,
progression-free survival;
PRO,
patient-reported outcomes;
q4w,
once every 4 weeks;
qd,
once daily;
R,
randomization;
vs,
versus;
w/o,
without.
Participating Sites
STELLAR-304 will be conducted in North America, South America, Europe, Middle East, and Asia Pacific. Call
1-888-393-5494
(toll-free) or
1-303-389-1847
for specific location and site information and to confirm
whether sites near you are still enrolling new patients.
Currently open or planned clinical site cities:
Trial sites may stop enrolling patients at any time. Please
check back if you do not see a trial site located near you.
