Avelumab Combined With Cetuximab and Irinotecan for Treatment Refractory Metastatic Colorectal Microsatellite Stable Cancer (AVETUXIRI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03608046|
Recruitment Status : Recruiting
First Posted : July 31, 2018
Last Update Posted : April 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Neoplasms, Malignant||Drug: Avelumab Drug: Cetuximab Injection Drug: Irinotecan||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||59 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Avelumab Combined With Cetuximab and Irinotecan for Treatment Refractory Metastatic Colorectal Microsatellite Stable Cancer - A Proof of Concept, Open Label Non-randomized Phase IIa Study. The AVETUXIRI Trial|
|Actual Study Start Date :||October 3, 2018|
|Estimated Primary Completion Date :||December 31, 2023|
|Estimated Study Completion Date :||December 31, 2023|
Experimental: Avelumab, Cetuximab, Irinotecan
Avelumab : administrated at a fixed dose of 10 mg/kg once every 2- week. Cetuximab: administered at 400 mg/m2 loading dose week 1, 250 mg/m2 from week 2 followed by 500 mg/m2 from week 3.
Irinotecan: administrated every 2 weeks (180 mg/m2).
Avelumab will be administered at a fixed dose of 10 mg/kg once every 2- week
Drug: Cetuximab Injection
Cetuximab will be administered at 400 mg/m2 loading dose week 1, 250 mg/m2 from week 2 followed by 500 mg/m2 from week 3 and irinotecan administered every 2 weeks (180 mg/m2).
Irinotecan will be administered every 2 weeks (180 mg/m2)
- Tumor response rate [ Time Frame: Up to 19 weeks ]The overall tumor response rate (ORR) defined as the proportion of all included patient with a confirmed best overall tumor response of PR or CR according to irRECIST 1.1 occuring until 19 weeks after study treatment start.
- Adverse events [ Time Frame: Up to 19 weeks ]Safety will be controlled
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03608046
|Contact: Marc Van Den Eynde, MD, PhD||00323 764 ext email@example.com|
|Cliniques Universitaires Saint-Luc||Recruiting|
|Brussels, Belgium, 1200|
|Contact: Marc Van Den Eynde, MD, PhD 0032 2 764 ext 1041 firstname.lastname@example.org|
|Contact: Marie-Laure Castella, Study coordinator 0032 2 764 ext 5427 email@example.com|
|Grand Hôpital de Charleroi||Recruiting|
|Charleroi, Belgium, 6000|
|Contact: Javier Carrasco, MD, PhD 0032 2 71 10 ext 20 20 firstname.lastname@example.org|