Renal Adjuvant

Key Eligibility Criteria:

Inclusion:
1.Histologically confirmed diagnosis of RCC with clear cell component with or without sarcomatoid features following complete resection of the primary tumor (radical or partial nephrectomy).
2. Note: Patients with microscopically positive soft tissue or vascular margins without gross residual disease are permitted.
a. Intermediate-high risk RCC:
i. pT2 Grade 4 or sarcomatoid features, N0M0
ii. pT3 any grade N0, M0
b. High-risk RCC:
i. pT4, any grade, N0, M0
ii. pT, any stage., any grade, N+, M0
c. cM1 NED RCC:
i. Participants who have had resection of primary tumor (radical or partical nephrectomy) and resection or definitive radiation or ablation of solid, isolated, soft tissue metastases (excluding brain and bone lesions) at the time of primary tumor removal (synchronous) or ≤1 year from primary tumor removal (metachronous).
3. Surgery (radical or partial nephrectomy or metastasectomy or ablation) >4 weeks but ≤ 16 weeks prior to study registration with no ongoing complications from surgery
4. No evidence of disease at time of randomization as assessed by investigator by either CT or MRI scan of the brain and chest, abdomen and pelvis
5. No prior systemic treatment for RCC

For pre-screening, please contact: Please reach out to the Disease specific research teams.