Colorectal Neoplasms, MalignantPhase 2AVETUXIRINCT03608046
Avelumab Combined With Cetuximab and Irinotecan for Treatment Refractory Metastatic Colorectal Microsatellite Stable Cancer
A Phase 2 study testing Avelumab, Cetuximab Injection and Irinotecan in people with Colorectal Neoplasms, Malignant, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 2 sites in Belgium.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Colorectal Neoplasms, Malignant
- What is being tested?
- Avelumab, Cetuximab Injection and Irinotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 2 sitesBelgium
- Study dates
- 3 Oct 2018to 31 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites, 2 recruiting
- Recruiting
Cliniques Universitaires Saint-Luc
Brussels, 1200
Marc Van Den Eynde, MD, PhD, 0032 2 764 ext. 1041, marc.vandeneynde@uclouvain.be
Marie-Laure Castella, Study coordinator, 0032 2 764 ext. 5427, marie-laure.castella@uclouvain.be
- Recruiting
Grand Hôpital de Charleroi
Charleroi, 6000
Javier Carrasco, MD, PhD, 0032 2 71 10 ext. 20 20, javier.carrasco@ghdc.be
About this study
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
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.
- Conditions
- Colorectal Neoplasms, Malignant
- Being tested
- Avelumab, Cetuximab Injection, Irinotecan
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AvelumabDrug
Avelumab will be administered at a fixed dose of 10 mg/kg once every 2- week
Cetuximab InjectionDrug
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).
IrinotecanDrug
Irinotecan will be administered every 2 weeks (180 mg/m2)
| Study group | Role | What they receive |
|---|---|---|
| Avelumab, Cetuximab, Irinotecan | Experimental | 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). Receives: Drug: Avelumab; Drug: Cetuximab Injection; Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response rate
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.
Measured: Up to 19 weeks
Secondary outcomes (1)
Adverse events
Safety will be controlled
Measured: Up to 19 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start3 Oct 2018
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal Neoplasms, MalignantStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03608046
- Sponsor's protocol ID
- UCL-mCRC-2018-MS100070-0095
- Acronym
- AVETUXIRI
- Status last verified
- Oct 2020
- First submitted
- 16 Jul 2018
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Huyghe N, Benidovskaya E, Masoodi T, Sinapi I, De Cuyper A, Vempalli F, Beyaert S, Bouzin C, Osorio FM, Ferraro L, van Baren N, Helaers R, Goffette P, Ghaye B, van Maanen A, Castella ML, Ceccarelli M, Bedognetti D, Galon J, Hendrickx WRL, Carrasco J, Van den Eynde M. Impact of the tumor immune contexture in microsatellite-stable metastatic colorectal cancer treated with avelumab, cetuximab, and irinotecan. Cell Rep Med. 2025 Jul 15;6(7):102201. doi: 10.1016/j.xcrm.2025.102201. Epub 2025 Jun 24.
PubMed 40562041
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03608046
- Acronym / sponsor ID
- AVETUXIRI / UCL-mCRC-2018-MS100070-0095
- Conditions
- Colorectal Neoplasms, Malignant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 3 Oct 2018 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 31 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Avelumab, Cetuximab, Irinotecan | Experimental | Drug: Avelumab, Drug: Cetuximab Injection, Drug: IrinotecanAvelumab : 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). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AvelumabAvelumab will be administered at a fixed dose of 10 mg/kg once every 2- week | Drug | Avelumab, Cetuximab, Irinotecan |
| Cetuximab InjectionCetuximab 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 | Avelumab, Cetuximab, Irinotecan |
| IrinotecanIrinotecan will be administered every 2 weeks (180 mg/m2) | Drug | Avelumab, Cetuximab, Irinotecan |
Primary outcome
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.
1 secondary outcome
Adverse events
Time frame: Up to 19 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Derived from this study: PubMed 40562041Huyghe N, Benidovskaya E, Masoodi T, Sinapi I, De Cuyper A, Vempalli F, Beyaert S, Bouzin C, Osorio FM, Ferraro L, van Baren N, Helaers R, Goffette P, Ghaye B, van Maanen A, Castella ML, Ceccarelli M, Bedognetti D, Galon J, Hendrickx WRL, Carrasco J, Van den Eynde M. Impact of the tumor immune contexture in microsatellite-stable metastatic colorectal cancer treated with avelumab, cetuximab, and irinotecan. Cell Rep Med. 2025 Jul 15;6(7):102201. doi: 10.1016/j.xcrm.2025.102201. Epub 2025 Jun 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Avelumab, Cetuximab Injection and Irinotecan in people with Colorectal Neoplasms, Malignant, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marc Van Den Eynde, MD, PhD (00323 764 ext. 1041, marc.vandeneynde@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor response rate (time frame: Up to 19 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03608046, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.