A Clinical Trial Comparing Efficacy And Safety Of Sunitinib Versus Placebo For TheTreatment Of Patients At High Risk Of Recurrent Renal Cell Cancer

• Drug: Sunitinib malate
  
  sunitinib malate 50 mg PO on schedule 4/2: 4 weeks on, 2 weeks off for 1 year or until disease recurrence or occurrence of a secondary malignancy, significant toxicity, or withdrawal of consent.
• Other: Placebo
  
  Placebo PO for 1 year on schedule 4/2: 4 weeks on, 2 weeks off or until disease recurrence or occurrence of a secondary malignancy, significant toxicity, or withdrawal of consent

• Experimental: A
  
  Intervention: Drug: Sunitinib malate
• Placebo Comparator: B
  
  Intervention: Other: Placebo

• Staehler M, Motzer RJ, George DJ, Pandha HS, Donskov F, Escudier B, Pantuck AJ, Patel A, DeAnnuntis L, Bhattacharyya H, Ramaswamy K, Zanotti G, Lin X, Lechuga M, Serfass L, Paty J, Ravaud A. Adjuvant sunitinib in patients with high-risk renal cell carcinoma: safety, therapy management, and patient-reported outcomes in the S-TRAC trial. Ann Oncol. 2018 Oct 1;29(10):2098-2104. doi: 10.1093/annonc/mdy329.
• Rini BI, Escudier B, Martini JF, Magheli A, Svedman C, Lopatin M, Knezevic D, Goddard AD, Febbo PG, Li R, Lin X, Valota O, Staehler M, Motzer RJ, Ravaud A. Validation of the 16-Gene Recurrence Score in Patients with Locoregional, High-Risk Renal Cell Carcinoma from a Phase III Trial of Adjuvant Sunitinib. Clin Cancer Res. 2018 Sep 15;24(18):4407-4415. doi: 10.1158/1078-0432.CCR-18-0323. Epub 2018 May 17.
• George DJ, Martini JF, Staehler M, Motzer RJ, Magheli A, Escudier B, Gerletti P, Li S, Casey M, Laguerre B, Pandha HS, Pantuck AJ, Patel A, Lechuga MJ, Ravaud A. Immune Biomarkers Predictive for Disease-Free Survival with Adjuvant Sunitinib in High-Risk Locoregional Renal Cell Carcinoma: From Randomized Phase III S-TRAC Study. Clin Cancer Res. 2018 Apr 1;24(7):1554-1561. doi: 10.1158/1078-0432.CCR-17-2822. Epub 2018 Jan 26.
• Motzer RJ, Ravaud A, Patard JJ, Pandha HS, George DJ, Patel A, Chang YH, Escudier B, Donskov F, Magheli A, Carteni G, Laguerre B, Tomczak P, Breza J, Gerletti P, Lechuga M, Lin X, Casey M, Serfass L, Pantuck AJ, Staehler M. Adjuvant Sunitinib for High-risk Renal Cell Carcinoma After Nephrectomy: Subgroup Analyses and Updated Overall Survival Results. Eur Urol. 2018 Jan;73(1):62-68. doi: 10.1016/j.eururo.2017.09.008. Epub 2017 Sep 28.
• Ravaud A, Motzer RJ, Pandha HS, George DJ, Pantuck AJ, Patel A, Chang YH, Escudier B, Donskov F, Magheli A, Carteni G, Laguerre B, Tomczak P, Breza J, Gerletti P, Lechuga M, Lin X, Martini JF, Ramaswamy K, Casey M, Staehler M, Patard JJ; S-TRAC Investigators. Adjuvant Sunitinib in High-Risk Renal-Cell Carcinoma after Nephrectomy. N Engl J Med. 2016 Dec 8;375(23):2246-2254. Epub 2016 Oct 9.

Inclusion Criteria:

• High risk renal cancer per modified UISS criteria
• Eastern Cooperative Oncology Group (ECOG) 0-2
• predominant clear cell histology
• No prior anti-cancer treatment
• Kidney tumor has been removed
• No evidence of macroscopic disease following surgery

Exclusion Criteria:

• Histologically undifferentiated carcinomas or collecting duct carcinoma, lymphoma, sarcoma or subjects with metastatic renal sites.
• Diagnosis of any second malignancy within the last 5 years, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma of the cervix uteri that has been adequately treated with no evidence of recurrent disease for 12 months
• known HIV or Hepatitis
• any severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration