Avelumab Combined With Cetuximab and Irinotecan for Treatment Refractory Metastatic Colorectal Microsatellite Stable Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-03

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Colorectal Neoplasms, Malignant

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Avelumab

Intervention Type DRUG

Avelumab will be administered at a fixed dose of 10 mg/kg once every 2- week

Cetuximab Injection

Intervention Type DRUG

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

Intervention Type DRUG

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

Interventions

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Avelumab

Avelumab will be administered at a fixed dose of 10 mg/kg once every 2- week

Intervention Type 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).

Intervention Type DRUG

Irinotecan

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No