This study is designed to evaluate the efficacy of belzutifan in combination with pembrolizumab with or without lenvatinib in the neoadjuvant setting, followed by adjuvant pembrolizumab versus adjuvant pembrolizumab alone, as treatment for participants with intermediate-high and high risk clear cell renal cell carcinoma (ccRCC).
Male/female participants who are at least 18 years of age on the day of signing informed consent.
T2 is defined as a tumour >7cm but limited to the kidney; grade 4 is per the International Society of Urological Pathology (ISUP) grading.
T3 is defined as tumour extension into major veins or perinephric tissues, but not into ipsilateral adrenal gland or beyond Gerota's fascia.
T4 is defined as a tumour involving the ipsilateral adrenal gland or invading beyond Gerota's fascia.
1. Has evidence of metastatic disease on screening imaging. 2. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137).
A pulse oximeter reading <92% at rest, or
Requires intermittent supplemental oxygen, or
Requires chronic supplemental oxygen. 12.Has an active infection requiring systemic intravenous therapy. 13.Has moderate to severe hepatic impairment (Child-Pugh B or C). 14.Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection.
Crossover
Neoadjuvant Pembrolizumab
Drug400mg q6w of Pembrolizumab will be administered before nephrectomy in cohorts A and B
Belzutifan
Drug120mg daily for 12w of Belzutifan will be administered before nephrectomy in Cohorts A and B
Lenvatinb
Drug20mg daily for 12 weeks of lenvatinib will be administered before nephrectomy in Cohort A
Response Rate
Radiographic response defined as a decrease of initial tumour size ≥30% from baseline to week 12 CT scan
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