A Study of Atezolizumab (an Engineered Anti-Programmed Death-Ligand 1 [PD-L1] Antibody) as Monotherapy or in Combination With Bevacizumab (Avastin®) Compared to Sunitinib (Sutent®) in Participants With Untreated Advanced Renal Cell Carcinoma
Summary
This multicenter, randomized, open-label study will evaluate the efficacy, safety and tolerability of atezolizumab as monotherapy or in combination with bevacizumab versus sunitinib in participants with histologically confirmed, inoperable, locally advanced or metastatic renal cell carcinoma who have not received prior systemic therapy either in the adjuvant or metastatic setting.
Timeline
- Start
- 2014-01-08
- Primary completion
- 2016-10-17
- Completion
- 2019-01-08
Outcome
Missed primary endpoint
registry analysis (superiority test); Atezolizumab and Bevacizumab vs Sunitinib; p = 0.9819; Hazard Ratio (HR) 1.00 (95% CI 0.69 to 1.45); Log Rank NCT01984242 ↗
registry analysis (superiority test); Atezolizumab and Bevacizumab vs Sunitinib; p = 0.0952; Hazard Ratio (HR) 0.64 (95% CI 0.38 to 1.08); Log Rank NCT01984242 ↗
Publications
- Haddad G, Guo J, Xi Y, Albayrak E, Huseni M, Hamidi H, Banchereau R, Kadel E, Dubey S, Carter C, Kapur P, Brugarolas J, Pedrosa I. Metastatic tropism of molecularly defined clear-cell renal cell carcinoma clusters. J Clin Invest. 2026 May 15;136(10):e195288. doi: 10.1172/JCI195288. eCollection 2026 May 15.
- Aldin A, Besiroglu B, Adams A, Monsef I, Piechotta V, Tomlinson E, Hornbach C, Dressen N, Goldkuhle M, Maisch P, Dahm P, Heidenreich A, Skoetz N. First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 May 4;5(5):CD013798. doi: 10.1002/14651858.CD013798.pub2.
- Pal SK, McDermott DF, Atkins MB, Escudier B, Rini BI, Motzer RJ, Fong L, Joseph RW, Oudard S, Ravaud A, Bracarda S, Suarez C, Lam ET, Choueiri TK, Ding B, Quach C, Hashimoto K, Schiff C, Piault-Louis E, Powles T. Patient-reported outcomes in a phase 2 study comparing atezolizumab alone or with bevacizumab vs sunitinib in previously untreated metastatic renal cell carcinoma. BJU Int. 2020 Jul;126(1):73-82. doi: 10.1111/bju.15058. Epub 2020 Apr 24.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atezolizumab | Monoclonal antibody | 1200 mg | — |
| Subject | Bevacizumab | Monoclonal antibody | 15 mg/kg | Intravenous |
| Comparator | Sunitinib | Small molecule | 50 mg | Oral |