Avelumab and Cetuximab in Combination With FOLFOX in Patients With Previously Untreated Metastatic Colorectal Cancer - The Phase II AVETUX-CRC Trial. (AVETUX)
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|ClinicalTrials.gov Identifier: NCT03174405|
Recruitment Status : Active, not recruiting
First Posted : June 2, 2017
Last Update Posted : October 15, 2021
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Colorectal Cancer||Drug: Avelumab||Phase 2|
The primary clinical objective is to determine the efficacy of a standard 1st line regimen (FOLFOX and cetuximab) in patients with RAS/v-Raf murine sarcoma viral oncogene homolog B (BRAF) wildtype, Microsatellite Instability (MSI) or icrosatellite Stability (MSS) MCRC with avelumab in terms of progression free survival rate after 12 months (acc. to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1).
The main secondary objective is to determine safety and tolerability, according to NCI Common Terminology Criteria for Adverse Events (CTCAE v4.03) and to the obtained data on vital signs, clinical parameters (oxygen saturation) and feasibility of the regimen. Further secondary objectives are to determine the efficacy of the experimental regimen in terms of objective response rate (acc. to RECIST v1.1 and irRECIST), and overall survival, to correlate clonal dynamics (RAS/EGFR subclones) with immune response signature to determine control of mutant subclones by the combination of anti-Epidermal growth factor receptor (EGFR) with anti-PD-L1and PD-L1 staining (and MSI status) with efficacy.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Avelumab and Cetuximab in Combination With FOLFOX in Patients With Previously Untreated Metastatic Colorectal Cancer - The Phase II AVETUX- Colorectal Cancer (CRC) Trial.|
|Actual Study Start Date :||July 17, 2017|
|Actual Primary Completion Date :||July 16, 2021|
|Estimated Study Completion Date :||July 2022|
All eligible patients will receive cetuximab and mFOLFOX6 combined avelumab from the second cycle onwards.
Cetuximab at a dose of 250 mg/m2 IV over 60 to 90 min (day 1 and 8) (first dose 400mg/m2) mFOLFOX6 (administration according to local standard) Oxaliplatin at a dose of 85 mg/m2 IV (day 1) 5-FU 400 mg/m2 IV bolus (day 1) LV at a dose of 400 mg/m2 iv (day 1) 5-FU at a dose of 2400 mg/m2 IV (day 1-3) Avelumab at a dose of 10mg/kg IV over 60 to 90 min (day 1 from cycle 2 onwards)
- Progression Free Survival Rate (PFS) @ 12 months [ Time Frame: during 12 months of treatment ]PFS according to RECIST 1.1 at 12months of treatment
- Safety [ Time Frame: 21 months ]Safety and tolerability (acc. to NCI CTC AE v4.03 and to the obtained data on vital signs, clinical parameters (oxygen saturation) and feasibility of the regimen)
- Response Rate (RR) [ Time Frame: 4 years ]Response Rate (RR) according to RECIST v1.1 and modified RECIST (mRECIST)
- Progression Free Survival (PFS) [ Time Frame: 4 years ]Progression Free Survival (PFS) according to RECIST v1.1 and mRECIST
- Overall survival (OS) [ Time Frame: 4 years ]Overall survival (OS)
- Translational research [ Time Frame: 48 months ]Translational research (correlation of clonal dynamics (RAS/EGFR subclones) with immune response signature to determine control of mutant subclones by the combination of anti-EGFR with anti-PD-L1, and PD-L1 (and MSI) status with efficacy
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): NCT03174405
|Principal Investigator:||Alexander Stein, PD Dr.||Universitätsklinikum Hamburg-Eppendorf|