Clinical Trial of Advanced Renal-Cell Carcinoma

Eligible patients had previously untreated advanced renal-cell carcinoma with a clear-cell component. Additional key inclusion criteria were the presence of at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1; age of 18 years or older; Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1 (on a 5-point scale in which higher numbers indicate greater disability); a fresh or archival tumor specimen; and adequate renal, cardiac, and hepatic function. Patients across all Memorial Sloan Kettering Cancer Center (MSKCC) and International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) prognostic risk groups were included (see the Definitions of Selected Terms and End Points section in the Supplementary Appendix, available with the full text of this article at NEJM.org).^{15 (link),16 (link)} Key exclusion criteria were active central nervous system metastases, autoimmune disease, and current or previous use of glucocorticoids or other immunosuppressants within 7 days before randomization.

Partial Protocol Preview
This section provides a glimpse into the protocol.
The remaining content is hidden due to licensing restrictions, but the full text is available at the following link: Access Free Full Text.

Motzer R.J., Penkov K., Haanen J., Rini B., Albiges L., Campbell M.T., Venugopal B., Kollmannsberger C., Negrier S., Uemura M., Lee J.L., Vasiliev A., Miller WH J.r., Gurney H., Schmidinger M., Larkin J., Atkins M.B., Bedke J., Alekseev B., Wang J., Mariani M., Robbins P.B., Chudnovsky A., Fowst C., Hariharan S., Huang B., di Pietro A, & Choueiri T.K. (2019). Avelumab plus Axitinib versus Sunitinib for Advanced Renal-Cell Carcinoma. The New England journal of medicine, 380(12), 1103-1115.

Publication 2019

Autoimmune disease Cancer Cardiac Central nervous system Clear cell renal cell carcinoma Disability Glucocorticoids Immunosuppressants Metastases Patients Renal Renal cell carcinoma Risk groups Tumor

Corresponding Organization :

Other organizations : Memorial Sloan Kettering Cancer Center, Euromedic, The Netherlands Cancer Institute, Cleveland Clinic, Institut Gustave Roussy, The University of Texas MD Anderson Cancer Center, Beatson West of Scotland Cancer Centre, University of Glasgow, BC Cancer Agency, Centre Léon Bérard, Université Claude Bernard Lyon 1, Osaka University Hospital, University of Ulsan, Asan Medical Center, Ulsan College, Russian Railways, Jewish General Hospital, McGill University, Macquarie University, Comprehensive Cancer Center Vienna, Medical University of Vienna, Royal Marsden NHS Foundation Trust, University of Tübingen, Pfizer (United States), Pfizer (Italy), Dana-Farber Cancer Institute, Dana-Farber Brigham Cancer Center, Brigham and Women's Hospital

Top 5 similar protocols

Protocol cited in 12 other protocols

Variable analysis

independent variables

Treatment (e.g., drug or placebo)

dependent variables

Clinical outcomes (e.g., tumor response, progression-free survival, overall survival)

control variables

Presence of at least one measurable lesion according to RECIST version 1.1
Age of 18 years or older
ECOG performance-status score of 0 or 1
Availability of a fresh or archival tumor specimen
Adequate renal, cardiac, and hepatic function
Inclusion of patients across all MSKCC and IMDC prognostic risk groups

positive controls

Not explicitly mentioned

negative controls

Exclusion of patients with active central nervous system metastases, autoimmune disease, and current or previous use of glucocorticoids or other immunosuppressants within 7 days before randomization

Annotations

Based on most similar protocols

Etiam vel ipsum. Morbi facilisis vestibulum nisl. Praesent cursus laoreet felis. Integer adipiscing pretium orci. Nulla facilisi. Quisque posuere bibendum purus. Nulla quam mauris, cursus eget, convallis ac, molestie non, enim. Aliquam congue. Quisque sagittis nonummy sapien. Proin molestie sem vitae urna. Maecenas lorem.

As authors may omit details in methods from publication, our AI will look for missing critical information across the 5 most similar protocols.

About PubCompare

Our mission is to provide scientists with the largest repository of trustworthy protocols and intelligent analytical tools, thereby offering them extensive information to design robust protocols aimed at minimizing the risk of failures.

We believe that the most crucial aspect is to grant scientists access to a wide range of reliable sources and new useful tools that surpass human capabilities.

However, we trust in allowing scientists to determine how to construct their own protocols based on this information, as they are the experts in their field.

Ready to get started?

Revolutionizing how scientists
search and build protocols!