Anti-PD-1/Everolimus in Advanced or Metastatic ClearCell Renal Cancer

• Research type

  Research Study

• Full title

  A Randomized, Open-Label, Phase 3 Study of BMS-936558 vs. Everolimus in Subjects with Advanced or Metastatic Clear-Cell Renal Cell Carcinoma Who Have Received Prior Anti-Angiogenic Therapy Pharmacogenetics Blood Sample Amendment 01- dated 18-jun-12, version 1.0

• IRAS ID

  111747

• Contact name

  Martin Gore

• Sponsor organisation

  Bristol-Myers Squibb International Corporation

• Eudract number

  2011-005132-26

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Research Summary:
  This is a multicentre, phase 3 study involving an investigational drug called BMS-936558, in patients with advanced or metastatic clear-cell renal cell carcinoma (RCC). The purpose of this study is to find out if patients with advanced RCC, who have been previously treated with anti-angiogenic therapy, survive for longer on BMS-936558 when compared to the immunotherapy agent, everolimus. Kidney cancer accounts for 2% of all cancers worldwide. RCC is the most common type of kidney cancer in adults (80% of cases). A significant number of RCC patients have advanced or metastatic (cancer which has spread to other parts of the body) cancer at diagnosis and unfortunately the survival rate is poor. Approximately 822 patients will take part, approximately 21 coming from the UK. The study is sponsored by Bristol Myers Squibb. Following a screening period, eligible patients will receive either BMS-936558 or everolimus. Patients and doctors will know what medication they have been assigned to. BMS-936558 is given intravenously (through your vein) via an infusion, while Everolimus is taken orally. Patients will undergo the following study procedures: CT/MRI scans, physical exams, vital signs such as BP checks, height, weight, body temperature, oxygen levels and blood samples for routine safety testing and study specific testing. All these procedures are common in the management of RCC. Participants will also be required to complete a questionnaire about their RCC symptoms at regular intervals throughout the study. Patients can remain in the study for as long as they are tolerating the treatment or until it has been confirmed that their cancer has worsened. The expected duration of participation may be up to 24 months.

  Summary of Results:
  https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Furl6570.hra.nhs.uk%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agba4yu73OCS9U-2BkKS40W1kfZLMhYNSL6uAQ3D-2BHysQkrDA4VQid-2BjN4I4LOGfrVah1l5y264Z-2BiDLmBJKX-2Bd4yTesQIN938KbwbtQ6VLFKnvxR870sUF7hn7A7-2BnbjKs-2BWw-3D-3Dyups_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YLSQANCDcUJjnzQ8SOKBoaH2bmLfMbjY2wqCb0YM9bCtqgv7MNAsCCgX79hWpZK24rF9VViIz2w4wDU6him4h-2FggfPhn0nvYhzHrvPjGtryvF-2BYWk13PYhcF9nYT7sdbpZR8Ja60VTcVJeSzrnruvKoAua3qNiRriDiqbO3MSXUSw-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7Cd10a951a434e4f05a21e08da33fe3f95%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637879464322665159%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=6ZxelqE38B7cs8tPVtdZExy4vbSzDEeOPXylGqNXG9Y%3D&reserved=0

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  12/SC/0559

• Date of REC Opinion

  3 Dec 2012

• REC opinion

  Further Information Favourable Opinion