**Author details**

the implications for STRAC. The results lacked clarity. Twenty-two patient representatives from the IKCC network were asked what degree of PFS advantage would be needed to justify taking sunitinib for 1 year. Approximately one-third of patients favored not taking sunitinib

**enrollment**

**Primary endpoint measure**

766 DFS February

800 DFS July 3,

2, 2017

2017

2017

2017

**Start date Completion date**

2022

2022

2023

2024

Recently, on November 2017, the FDA approved the use sunitinib for the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma following nephrectomy. The

Targeted therapy has become the current mainstay in the management of metastatic RCC and its success with advanced stage disease has been the driving force behind the increasing number of targeted therapy trials in the adjuvant setting. The emergence of immune checkpoint inhibitors in the last couple of years has further led to important advances in our understanding and management of mRCC. However, many ongoing trials are yet to be completed in both cases and there is ample potential for further investigation—especially with respect to combinational therapy regimes. This includes the combination of TKIs with immune therapies (e.g., NCT01513187: Pazopanib with Interferon Alfa 2-A), combination of TKIs with chemotherapeutics (e.g., NCT00556049: Sunitinib with Gemcitabine), and the combination of anti-VEGF antibodies and mTOR inhibitors (e.g., NCT01399918: bevacizumab and everolimus). All of these treatments may be of interest for future adjuvant trials in RCC if they are found to be effective in stage IV disease. However, they may have more side effects, making them less suitable in particular for adjuvant treatment. Nonetheless, the current information, which has resulted from all the progress in the field, remains incongruent. While the current set of completed adjuvant clinical trials have provided negative or conflicting results (ARISER, PROTECT, S-TRAC vs. ASSURE), there are additional large-scale trials that are still in progress. The existing trial design has several limitations, the key one being the overall lack of standardization seen across various assessment criteria. Future directions include

when faced with the S-TRAC results [79].

**Trial name Trial ID Intervention Estimated** 

(pre-Nx)

KEYNOTE-564 NCT03142334 Pembrolizumab 950 DFS June 9,

ipilimumab

IMmotion010 NCT03024996 Atezolizumab 664 DFS January 3,

PROSPER NCT03055013 Nivolumab

186 Evolving Trends in Kidney Cancer

CheckMate 914 NCT03138512 Nivolumab,

**Table 6.** Ongoing adjuvant and neo-adjuvant clinical trials.

approval was based on (S-TRAC) trail.

**8. Conclusions and future directions**

Fadil Hassan1 , Shahid Lambe1 , Kiran Sharma<sup>1</sup> and Anil Kapoor<sup>2</sup> \*

