BMS-936558 versus investigator's choice in advanced melanoma

• Research type

  Research Study

• Full title

  A Randomised, Open-Label Phase 3 Trial of BMS-936558 versus Investigator's Choice in Advanced (Unresectable or Metastatic) Melanoma Patients Progressing Post Anti-CTLA-4 Therapy

• IRAS ID

  114080

• Contact name

  Elizabeth Ruth Plummer

• Sponsor organisation

  Bristol Myers Squibb International Corporation

• Eudract number

  2012-001828-35

• Clinicaltrials.gov Identifier

  NCT01721746

• Research summary

  Summary Of Research
  This is a multicentre, phase 3 study involving an investigational drug called BMS-936558, in patients with advanced (unresectable or metastatic) melanoma. The purpose of this study is to find out if patients with advanced melanoma, who have been previously treated, survive for longer on BMS-936558 when compared to the chemotherapy agents, dacarbazine and carboplatin/paclitaxel.The lifetime risk of developing invasive melanoma has been dramatically increasing and the overall mortality from melanoma continues to rise. A significant number of patients have advanced or metastatic cancer (which has spread to other parts of the body) at diagnosis and unfortunately the survival rate remains quite poor. BMS-936558 is designed to work by helping the body's own immune system attack the cancer cells. Approximately 390 patients will take part from centres around the world, approximately 18 from the UK. The study is sponsored by Bristol Myers Squibb. Following a screening period, eligible patients will receive either BMS-936558 or Investigator's choice (dacarbazine or carboplatin/paclitaxel). Patients and doctors will know what medication they have been assigned to. All medications are given intravenously (through the vein) via an infusion. Patients will undergo the following study procedures: CT/MRI scans, physical exams, vital signs such as blood pressure checks, height, weight, body temperature, blood samples for routine safety testing and study specific testing, oxygen levels. All these procedures are fairly standard in the management of melanoma. Participants will also be required to complete a questionnaire about their melanoma 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. At the conclusion of the study patients who continue to gain clinical benefit may be eligible to continue to receive study drug via an extension to the study.

  Summary Of Results
  please refer to clinicaltrials.gov: https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Furl6570.hra.nhs.uk%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbRehJ-2Fi4xyo44sEgJVCl5BcbW9wgc64X2JjNxW-2BqMpAMITwD0JZ1j8vMqbwDVw1tdqW5DCGR9sx9040pb4d0oZX16hJLzh-2BO9tO0wN2CwpZo8G0iaVqJUMyIm5LYvhwxmHaAu8ndRVua4-2Fs-2BZihH2voG4tcqmdzgAKEfjvlLlSSzEuoH4edIJDlf2TgeVy0OFjePUnTxQSyy4rY68maMihdAuqsvloTLcmfQL-2F6yVBj-2BbFvBaSKI-2FlBO6jPs4av8dkythfCegVrWBEn-2BLX3C4eVi6CM0rzGCaZ-2BpXwivX2JugrRgDlvbkrgEeIiqhZMgyzyRJ62aBcyAXoaw-2Bpdisfg-3Dv-wf_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YLDThT6zWXeB5R4sKLiZ4QnJdbAu0mGxMd878T2IBLpqrWW0jbo798V635zJxUBCBqkAYD73ZYQEWweFTyrKl374syb7aVx7YzwJxT0TWbmdH-2FrjwCYdAlHJPEREF2QC-2B7-2BBBW-2FgO5KM85G2ji3yeLv6fLGqMOtA5ArLzEpSCt1CA-3D-3D&data=04%7C01%7Capprovals%40hra.nhs.uk%7C0a80b2e1dbf14223fc7a08d9fb938d40%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637817433461843180%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=tadoAuWPW1j0z21%2BV9AArIwZHM5jNKrf1viZsoYLUhU%3D&reserved=0

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  13/NE/0011

• Date of REC Opinion

  26 Feb 2013

• REC opinion

  Further Information Favourable Opinion