IMA910-101

• Research type

  Research Study

• Full title

  An open label, multicenter Phase 1-2 study to investigate the effectiveness, safety and immunogenicity of a monotherapy with intradermal IMA910 plus GM-CSF following pre-treatment with low-dose cyclophosphamide in advanced colorectal carcinoma patients who have successfully completed a 12 week first-line treatment with oxaliplatin-based chemotherapy.

• IRAS ID

  10793

• Sponsor organisation

  immatics biotechnologies GmbH

• Eudract number

  2007-005666-12

• Clinicaltrials.gov Identifier

  00785122

• Research summary

  IMA910-101 - Peptide-based vaccination therapy in colorectal carcinoma Objective The objective of the study is to evaluate a new cancer vaccine IMA910 in the treatment of patients with advanced colorectal cancer. It will be investigated whether IMA910 in combination with GM-CSF (granulocyte-macrophage colony-stimulating factor) as immune modulator can prevent cancer progression.TreatmentColorectal cancer cells carry characteristic protein structures (tumor-associated peptides) on their surface by which they differ from other cells in the body. By means of such tumor-associated peptides the immune system can recognize and attack tumor cells. IMA910 consists of 13 synthetic tumor-associated peptides and will be applied in combination with GM-CSF as an immune modulator over a period of 8 months. IMA910 attempts to activate the immune system to attack tumor cells without harming normal cells. A single application of cyclophosphamide (Endoxan©) will also be given at a very low dose and is supposed to act as an immune modulator and might further improve the response to IMA910.Inclusion criteriaThis study is open for patients with advanced colorectal carcinoma. Furthermore, in order to be eligible for the study, patients must have received prior oxaliplatin-based chemotherapy for 12-16 weeks which could stop the tumor from growing. Patients with brain metastases cannot participate in this study. This phase 1-2 study is being conducted in more than 30 investigational sites in eight European countries. A paramount aspect of this present application is that the phase 1 part of the protocol (i.e. treatment of the first 6 patients) has been successfully completed. Following evaluation of safety data obtained from these 6 subjects an independent Data Safety Monitoring Board (DSMB) concluded that safety is amply warranted in order to continue with the phase 2 part of this study. Please refer to the attached Interim Safety Report (dated 12/12/2008) for further details related to the phase 1 part of this trial.The vaccine IMA910 is developed by Immatics biotechnologies GmbH, a biopharmaceutical company located in Tuebingen (Germany).

• REC name

  West of Scotland REC 1

• REC reference

  09/S0703/19

• Date of REC Opinion

  11 Mar 2009

• REC opinion

  Further Information Favourable Opinion