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

immatics biotechnologies GmbH0 sites90 target enrollmentDecember 7, 2007

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Adult HLA-A*02-positive patients who have been diagnosed with unresectable, locally advanced and/or metastatic colorectal cancer before first-line chemotherapy. Patients must have completed a 12 week first-line oxaliplatin-based standard chemotherapy (e.g. FOLFOX or XELOX) with either complete or partial response or stable disease as the outcome.
Sponsor: immatics biotechnologies GmbH
Enrollment: 90
Status: Active, not recruiting
Last Updated: 13 years ago

No summary available.

Registry

who.int

Start Date

December 7, 2007

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Aged at least 18 years
•HLA type: HLA\-A\*02\-positive
•Histologically confirmed colorectal adenocarcinoma (CRC)
•Radiological evidence (CT/MRI) of unresectable locally advanced and/or metastatic CRC prior to 12 week first\-line oxaliplatin\-based standard chemotherapy
•12 week first\-line chemotherapy with an oxaliplatin\-based regimen according to an established standard protocol (e.g. FOLFOX or XELOX) administered at the following minimum dosages over this 12 week period: Oxaliplatin 400 mg/m2, Fluorouracil (5FU) 10\.000 mg/m2 or Capecitabine 84\.000 mg/m2 (a time window for application of first\-line chemotherapy of \+4 weeks is allowed)
•Response (CR, PR) or stabilization (SD) following a 12 week first\-line oxaliplatin\-based standard chemotherapy shown by radiological evidence (CT/MRI after last cycle of first\-line oxaliplatin\-based standard chemotherapy compared to CT/MRI taken before start of first\-line oxaliplatin\-based standard chemotherapy)
•Patients accept a chemotherapy\-free interval under close observation (CT or MRI scans performed every 9 weeks)
•Maximum period between start of study treatment and start of the last cycle of standard chemotherapy (\= first day of last cycle of standard chemotherapy) is 42 days; minimum period is 18 days
•Currently no other standard therapy indicated
•Karnofsky Performance Status ?80%

•Any adjuvant systemic or local chemotherapy if ended ?6 months before start of systemic first\-line oxaliplatin\-based standard chemotherapy
•Progressive disease during or at the end of 12 week systemic first\-line oxaliplatin based standard chemotherapy
•CT/MRI scans taken more than 9 weeks before start of first\-line oxaliplatin\-based standard chemotherapy
•Response to 12 week first\-line oxaliplatin\-based standard chemotherapy resulting in resectable disease; curative treatment intended
•Immunosuppressive therapy within 10 days before first vaccination e.g. corticosteroid treatment (inhalative corticosteroids for e.g. asthma are allowed)
•Radiotherapy during and/or following the 12 week first\-line oxaliplatin\-based standard chemotherapy (palliative radiotherapy for bone metastasis is allowed)
•Concurrent or prior participation in a clinical trial applying interventional procedures (e.g. application of investigational drugs, surgical interventions) within the last 30 days
•History of other malignant tumours within the last 5 years, except basal cell carcinoma or curatively excised cervical carcinoma in situ
•Presence of known brain metastasis on MRI or CT scans
•Current partial or complete bowel obstruction