IMA901 in patients receiving sunitinib for advanced/metastatic RCC

• Research type

  Research Study

• Full title

  A randomized, controlled Phase III study investigating IMA901 multipeptide cancer vaccine in patients receiving sunitinib as first-line therapy for advanced/metastatic renal cell carcinoma

• IRAS ID

  68708

• Contact name

  Tim Eisen

• Sponsor organisation

  immatics biotechnologies GmbH

• Eudract number

  2010-022459-45

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  IMA901 is a new cancer vaccine which is being developed for the treatment of renal cell cancer. It is hoped to work by activating specific white blood cells of the body??s immune system which will then attack and destroy the tumour cells. IMA901 will be given together with two other drugs ?? GM-CSF and cyclophosphamide - which are both routinely used in patients suffering from cancer. It is thought that they help to influence the immune system and make IMA901 more effective. There is also evidence that sunitinib, a standard first-line therapy (first therapy given after diagnosis) to treat renal cell cancer, can help the activation of the immune system induced by IMA901. Therefore in this study IMA901 will be administered on top of sunitinib and together with GM-CSF and cyclophosphamide in order to stimulate a strong immune response.The study patients must test positive for a certain marker in their blood called HLA-A*02, which is thought to be necessary to benefit from this treatment. They must also have metastatic and/ or locally advanced renal cell cancer, be aged 18 years or older, have a favourable or intermediate risk and be considered as candidates for standard first-line therapy with sunitinib.Eligible patients will randomised to either the control arm or the vaccination arm of the study. Patients in the control arm will receive sunitinib alone and patients in the vaccination arm will receive IMA901 , GM-CSF and cyclophosphamide in addition to sunitinib. An individual patient's time on the study will be between 14 and 25 months. After this study period, patients will have a long term, procedure free, follow-up for a maximum of 8 years. The main aim of this study is to investigate whether IMA901 can extend survival in patients with metastatic and/or locally advanced RCC when added to standard first-line therapy with sunitinib.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  11/EE/0012

• Date of REC Opinion

  8 Apr 2011

• REC opinion

  Further Information Favourable Opinion