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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 : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study Description
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Brief Summary:
Cancer immunotherapy with immunostimulatory antibodies targeting the CTLA-4 or PD-1/PD-L1 pathways has demonstrated its efficacy in variable proportions of cancer. For metastatic colorectal cancer (mCRC) it appeared that only the small subgroup of patients with MSI-H tumors (microsatellite instability-high phenotype) had a clinically meaningful response to the anti-PD-1- L1 antibodies. In the majority group of non-MSI-H CRC (90-95% of patients), current research expect that additional means would be able to render the tumor "immunogenic" (like MSI-H CRC) and increase the intratumoral immune infiltrate which is the prerequisite to observe a benefit from PD1-PD-L1 inhibitors. Combinations of immune checkpoint inhibitors and procedures that increase intratumoral immune responses, such as targeted therapy, are actively explored.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms, Malignant Drug: Avelumab Drug: Cetuximab Injection Drug: Irinotecan Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 59 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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).

 Drug: Avelumab
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).

Drug: Irinotecan
Irinotecan will be administered every 2 weeks (180 mg/m2)


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: Up to 19 weeks ]
    Safety will be controlled


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 and over, Performance status: ECOG 0-1
  • Histologically proven metastatic colorectal adenocarcinoma, refractory to standard chemotherapy (fluoropyrimidine, oxaliplatin, irinotecan) and anti-EGFR treatment (only for RAS WT tumor)
  • Measurable disease (RECIST 1.1)
  • Metastasis accessible for sequential biopsies
  • Patient consent for metastasis biopsies in the study protocol
  • BRAF V600E wild-type and MSS tumors
  • Adequate normal organ and marrow function (see adequate section of the full protocol for definition)
  • Life expectancy of at least 4 months

Exclusion Criteria:

  • Concurrent chronic systemic immune therapy, chemotherapy, or hormone therapy that are not indicated in the study protocol
  • Systemic autoimmune disease,
  • Chronic treatment with corticoids or other immunosuppressive treatment
  • Clinically significant cardiac, lung or general disease despite optimal treatment
  • Non-progressive disease following irinotecan-based treatment.
  • For RAS WT, non-progressive disease following anti-EGFR treatment.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Marc Van Den Eynde, MD, PhD 00323 764 ext 1041 marc.vandeneynde@uclouvain.be

Locations
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Belgium
Cliniques Universitaires Saint-Luc Recruiting
Brussels, Belgium, 1200
Contact: Marc Van Den Eynde, MD, PhD    0032 2 764 ext 1041    marc.vandeneynde@uclouvain.be   
Contact: Marie-Laure Castella, Study coordinator    0032 2 764 ext 5427    marie-laure.castella@uclouvain.be   
Grand Hôpital de Charleroi Recruiting
Charleroi, Belgium, 6000
Contact: Javier Carrasco, MD, PhD    0032 2 71 10 ext 20 20    javier.carrasco@ghdc.be   
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
More Information
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Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT03608046    
Other Study ID Numbers: UCL-mCRC-2018-MS100070-0095
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
 Rectal Diseases
Irinotecan
Cetuximab
Avelumab
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Immunological