Clinical trial · Interventional
Erbitux MEtastatic Colorectal Cancer Strategy Study
Erbitux MEtastatic Colorectal Cancer Strategy Study (ERMES): A Phase III Randomized Two Arm Study With FOLFIRI + Cetuximab Until Disease Progression Compared to FOLFIRI + Cetuximab for 8 Cycles Followed by Cetuximab Alone Until Disease Progression in First Line Treatment of Patients With RAS and BRAF Wild Type Metastatic Colorectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
* To investigate whether cetuximab alone (given until progression or cumulative toxicity) after 8 cycles of FOLFIRI + cetuximab results in a non inferior Progression Free Survival when compared with continuous FOLFIRI + cetuximab (given until progression or cumulative toxicity). * To assess whether an improvement in the incidence of grade 3-4 hematological and non-hematological adverse events (AEs) can be achieved in the experimental arm (cetuximab alone after 8 cycles FOLFIRI + cetuximab) as compared to the continuous chemotherapy arm (FOLFIRI plus cetuximab) * To explore the possibility of using liquid biopsies for molecular profiling as well as monitoring treatment activity in mCRC pts receiving cetuximab based therapy
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Antineoplastic Agents | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab | Drug | Cetuximab | ALIAS |
| FOLFIRI | Drug | FOLFIRI Regimen | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- FOLFIRI + Cetuximab until disease progression
- description
- FOLFIRI + Cetuximab until disease progression
- interventionNames
- Drug: Cetuximab
- Drug: FOLFIRI
- type
- EXPERIMENTAL
- label
- FOLFIRI + Cetuximab followed by Cetuximab alone
- description
- FOLFIRI + Cetuximab for 8 cycles followed by Cetuximab alone until disease progression
- interventionNames
- Drug: Cetuximab
- Drug: FOLFIRI
Primary outcomes (2)
- measure
- Progression-free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven diagnosis of colorectal adenocarcinoma * Diagnosis of metastatic disease * RAS and BRAF wildtype * Measurable disease according to RECIST criteria v1.1 * Male or female over 18 years of age * ECOG Performance Status 2 * Life expectancy of at least 3 months * Adequate bone marrow, liver and renal function assessed within 14 days before starting study treatment * If female and of childbearing potential, have a negative result on a pregnancy test performed a maximum of 7 days before initiation of study treatment * If female and of childbearing potential, or if male, agreement to use adequate contraception * Signed informed consent obtained at screening Exclusion Criteria: * Any contraindication to use cetuximab, irinotecan, 5 FU or folinic acid * Active uncontrolled infections or active disseminated intravascular coagulation * Past or current history of malignancies other than colorectal carcinoma, except for curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix * Pregnancy. * Breastfeeding. * Grade III or IV heart failure (NYHA classification) * Myocardial infarction, unstable angina pectoris, balloon angioplasty (PTCA) with or without stenting within the past 12 months before inclusion in the study * Cardiac arrhythmias requiring anti-arrhythmic therapy, with the exception of beta blockers or digoxin * Medical or psychological impairments associated with restricted ability to give consent or not allowing conduct of the study * Previous chemotherapy for colorectal cancer with the exception of adjuvant treatment, completed at least 6 months before entering the study * Participation in a clinical study or experimental drug treatment within 30 days prior to study inclusion or during participation in the study * Known or clinically suspected brain metastases * History of acute or subacute intestinal occlusion or chronic inflammatory bowel disease or chronic diarrhoea * Severe, non-healing wounds, ulcers or bone fractures * Uncontrolled hypertension * Marked proteinuria (nephrotic syndrome) * Known DPD deficiency (specific screening not required) * Known history of alcohol or drug abuse * A significant concomitant disease which, in the investigating physician's opinion, rules out the patient's participation in the study * Absent or restricted legal capacity
References
Publications (1)
- DERIVEDPinto C, Orlandi A, Normanno N, Maiello E, Calegari MA, Antonuzzo L, Bordonaro R, Zampino MG, Pini S, Bergamo F, Tonini G, Avallone A, Latiano TP, Rosati G, Cogoni AA, Ballestrero A, Zaniboni A, Roselli M, Tamberi S, Barone C. Fluorouracil, Leucovorin, and Irinotecan Plus Cetuximab Versus Cetuximab as Maintenance Therapy in First-Line Therapy for RAS and BRAF Wild-Type Metastatic Colorectal Cancer: Phase III ERMES Study. J Clin Oncol. 2024 Apr 10;42(11):1278-1287. doi: 10.1200/JCO.23.01021. Epub 2024 Jan 5. PMID 38181312