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AzTrials

Metastatic Colorectal Cancer (mCRC)Phase 3CAPRI-3 GOIMNCT07389265

Continuation of Cetuximab Beyond First-Line Progression in Metastatic Colorectal Cancer

A Phase 3 study testing Erbitux (Cetuximab), Bevacizumab and FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin) in people with Metastatic Colorectal Cancer (mCRC), run by University of Campania Luigi Vanvitelli at 41 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this Phase 3 clinical trial is to evaluate whether continuing cetuximab treatment beyond first-line progression can improve outcomes in patients with metastatic colorectal cancer whose tumors are RAS and BRAF wild-type. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Colorectal Cancer (mCRC)
What is being tested?
Erbitux (Cetuximab), Bevacizumab and FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
480 participants
Where
41 sitesin 2 countries
Study dates
1 Oct 2025to Oct 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically proven diagnosis of colorectal adenocarcinoma.
  • Diagnosis of metastatic disease.
  • Efficacy of a first line therapy containing anti-EGFR drug with a major response achieved (i.e. complete or partial response according to RECIST criteria v1.1) or a prolonged (at least 6 months) stable disease.
  • Progression to first line therapy.
  • RAS and BRAF wild-type status of FFPE analysis of primary colorectal cancer and/or related metastasis.
  • RAS (NRAS and KRAS exon 2,3 and 4), BRAFV600E, PIK3CA, EGFR ECD wild-type and HER2 not amplified in liquid biopsy at the time of screening (according to NGS, Foundation/Roche).
Show all 22Show fewer
  • Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST criteria, vers.1.1).
  • Male or female patients ≥ 18 years of age.
  • ECOG Performance Status 0-1.
  • Adequate bone marrow, liver and renal function assessed within 14 days before starting study treatment as defined by the following parameters:
  • Bone marrow:
  • Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L
  • Hemoglobin (Hgb) ≥ 9 g/dL
  • Platelets ≥ 100 x 109/L
  • Liver function:
  • Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and ALT (SGPT) ≤ 2.5 x ULN, except in patients with tumor involvement of the liver who must have AST and ALT ≤ 5 x ULN
  • Renal function:
  • Serum creatinine ≤ 1.5 x ULN or 24-hour clearance ≥ 50 mL/min
  • 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.
  • A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
  • If female and of childbearing potential, or if male, agreement to use adequate contraception (e.g., abstinence, intrauterine device, oral contraceptive, or double-barrier method), during the study and until at least 6 months after last dose of study treatment administration, based on the judgment of the Investigator or a designated associate.
  • Signed informed consent obtained before screening.

Who cannot join

  • Any contraindication to the use of cetuximab, bevacizumab, Irinotecan, 5-FU, oxaliplatin, folic acid.
  • Active uncontrolled infections, active disseminated intravascular coagulation or history of interstitial lung disease.
  • Past or current history of malignancies other than colorectal carcinoma, except for curatively treated basal and squamous cell carcinoma of the skin cancer or in situ carcinoma of the cervix.
  • Pregnancy (exclusion to be ascertained by a beta hCG test).
  • Breastfeeding.
  • Fertile women (<2 years after last menstruation) and men of childbearing potential not willing to use effective means of contraception.
Show all 19Show fewer
  • Myocardial infarction, unstable angina pectoris, balloon angioplasty (PTCA) with or without stenting within the past 12 months before inclusion in the study, Grade III or IV heart failure (NYHA classification).
  • 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.
  • 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 diarrhea.
  • Severe, non-healing wounds, ulcers or bone fractures.
  • 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.
  • Patients with known dMMR or MSI-H tumors who are eligible for approved immune checkpoint inhibitor therapy will be excluded from the trial, unless ICI therapy is contraindicated or declined by the patient. This ensures alignment with current standard of care.

Trial locations and contacts

41 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Fortunato Ciardiello contact

0815666760

fortunato.ciardiello@unicampania.it

Stefania Napolitano contact

stefania.napolitano@unicampania.it

41 sites in 2 countries

Italy30 sites, 30 recruiting

  • A.O.U. Ospedali Riuniti

    Ancona

    Rossana Berardi

    Not yet recruiting

  • AORN S. Giuseppe Moscati

    Avellino

    Giuseppe Santabarbara

    Not yet recruiting

  • Centro di Riferimento Oncologico (C.R.O.) IRCCS

    Aviano

    Michela Guardascione

    Not yet recruiting

  • IRCCS Istituto Tumori "Giovanni Paolo II"

    Bari

    Nicola Silvestris

    Not yet recruiting

  • Fondazione Poliambulanza Istituto Ospedaliero

    Brescia

    Michela Libertini

    Not yet recruiting

  • Ospedale IRCCS 'Saverio de Bellis'

    Castellana Grotte

    Claudio Lotesoriere

    Not yet recruiting

  • Nome EnteA.R.N.A.S. Garibaldi - P.O. Garibaldi-Nesima

    Catania

    Roberto Bordonaro

    Not yet recruiting

  • Azienda Ospedaliero-Universitaria Renato Dulbecco

    Catanzaro

    Pierosandro Tagliaferri

    Not yet recruiting

  • A.O.U. Careggi

    Florence

    Lorenzo Antonuzzo

    Not yet recruiting

  • P.O. 'Vito Fazzi'

    Lecce

    Silvana Leo

    Not yet recruiting

  • Istituto Romagnolo per lo Studio dei Tumori 'Dino Amadori'

    Meldola

    Alessandro Passardi

    Not yet recruiting

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan

    Andrea Sartore Bianchi

    Not yet recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan

    Filippo Pietrantonio

    Not yet recruiting

  • Istituto Europeo di Oncologia

    Milan

    Maria Giulia Zampino

    Not yet recruiting

  • Casa di Cura Villa Maria

    Mirabella Eclano

    Antonio Febbraro

    Not yet recruiting

  • A.O.U. dell'Università degli studi della Campania 'Luigi Vanvitelli'

    Naples

    Fortunato Ciardiello

    Recruiting

  • A.O.U. Federico II

    Naples

    Chiara Carlomagno

    Not yet recruiting

  • IRCCS I.N.T. 'Fondazione G. Pascale'

    Naples

    Antonio Avallone

    Not yet recruiting

  • Istituto Oncologico Veneto IRCCS

    Padova

    Francesca Bergamo

    Not yet recruiting

  • ARNAS Civico - Di Cristina-Benfratelli - P. O. 'Civico e Benfratelli'

    Palermo

    Marco Messina

    Not yet recruiting

  • Casa di cura Macchiarella

    Palermo

    Alfredo Colombo

    Not yet recruiting

  • A.O.U. Pisana

    Pisa

    Chiara Cremolini

    Not yet recruiting

  • Azienda USL IRCCS di Reggio Emilia

    Reggio Emilia

    Maria Banzi

    Not yet recruiting

  • Fondazione Policlinico Universitario 'Agostino Gemelli' IRCCS

    Roma

    Giampaolo Tortora

    Not yet recruiting

  • IRCCS Istituto clinico Humanitas

    Rozzano

    Alberto Puccini

    Not yet recruiting

  • Fondazione IRCCS Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo

    Tiziana Pia Latiano

    Not yet recruiting

  • A.O.U. Sassari

    Sassari

    Alessio Cogoni

    Not yet recruiting

  • Ospedale San Giuseppe Moscati

    Statte

    Salvatore Pisconti

    Not yet recruiting

  • A.O. 'Pia Fondazione Cardinale G.Panico'

    Tricase

    Emiliano Tamburini

    Not yet recruiting

  • IRCCS Ospedale Sacro Cuore Don Calabria

    Veneto

    Stefania Gori

    Not yet recruiting

Other trials in Italy

Spain11 sites, 11 recruiting

  • Hospital del Mar

    Barcelona

    Clara Montagut Viladot

    Not yet recruiting

  • Hospital Universitari Vall d´Hebron

    Barcelona

    Francesc Salvà Ballabrera

    Not yet recruiting

  • Hospital General Universitario Santa Lucía

    Cartagena

    Paola Pimentel Càceres

    Not yet recruiting

  • Hospital Universitario Reina Sofía

    Córdoba

    Maria Jose Ortiz Morales

    Not yet recruiting

  • Hospital Universitario Virgen de las Nieves

    Granada

    Encarnaciòn Gonzàles Flores

    Not yet recruiting

  • Instituto Catalán de Oncología. Hospital Duran i Reynals

    L'Hospitalet de Llobregat

    Cristina Santos Vivas

    Not yet recruiting

  • Hospital Universitario 12 de Octubre

    Madrid

    Cristina Grávalos Castro

    Not yet recruiting

  • Hospital Universitario Gregorio Marañón

    Madrid

    Pilar Garcìa Alfonso

    Not yet recruiting

  • Hospital Universitario Regional de Málaga

    Málaga

    Julia Alcaide Garcìa

    Not yet recruiting

  • Hospital Universitario de Navarra

    Pamplona

    Ruth Vera Garcìa

    Not yet recruiting

  • Hospital Universitario Marqués de Valdecilla

    Santander

    Fernando Rivera Herrero

    Not yet recruiting

Other trials in Spain

About this study

Official title: CAPRI-3 GOIM Study: Phase 3 Clinical Study to Evaluate the Use of Continuing Cetuximab Treatment Beyond First Line Progression in Molecular Selected Metastatic Colorectal Cancer Patients.

The goal of this Phase 3 clinical trial is to evaluate whether continuing cetuximab treatment beyond first-line progression can improve outcomes in patients with metastatic colorectal cancer whose tumors are RAS and BRAF wild-type. The study will compare the effectiveness of chemotherapy given together with cetuximab versus chemotherapy given together with bevacizumab. Researchers aim to determine whether cetuximab continuation improves tumor response, progression-free survival, overall survival, and safety in this patient population.

Eligible participants are adults with metastatic colorectal cancer who have previously responded to first-line treatment with chemotherapy combined with an anti-EGFR antibody. Before starting therapy, patients will undergo molecular testing using liquid biopsy to confirm tumor characteristics. They will then receive chemotherapy with either cetuximab or bevacizumab every two weeks, and their disease will be monitored regularly with CT or MRI scans, laboratory tests, and clinical evaluations. During the study, patients will also provide biological samples for translational research.

This trial will enroll about 360 patients across sites in Italy and Spain and is designed to provide new evidence on whether cetuximab continuation beyond first-line treatment can offer a meaningful clinical benefit compared with standard therapy.

Read the detailed description

Metastatic colorectal cancer (mCRC) is one of the most common and lethal cancers worldwide. Despite progress with chemotherapy and targeted therapies, many patients experience disease progression after first-line treatment. In recent years, drugs targeting the Epidermal Growth Factor Receptor (EGFR), such as cetuximab, have shown significant benefit in patients with RAS and BRAF wild-type tumors. However, it remains unclear whether continuing cetuximab beyond progression, while changing the chemotherapy backbone, can provide additional benefit compared to switching to an alternative targeted treatment.

The CAPRI-3 study is a randomized, multicenter, open-label Phase 3 clinical trial designed to address this question. The study will enroll approximately 360 adult patients with metastatic colorectal cancer in Italy and Spain. All participants must have tumors that are RAS and BRAF wild-type, as well as PIK3CA and EGFR extracellular domain wild-type and HER2 non-amplified, as determined by next-generation sequencing on liquid biopsy at the time of screening. Eligible patients will have previously received a first-line regimen with chemotherapy plus an anti-EGFR antibody (cetuximab or panitumumab) and achieved either a complete or partial response, or prolonged stable disease, before disease progression.

Patients will be randomized in a 1:1 ratio to receive a standard chemotherapy doublet (FOLFOX or FOLFIRI, depending on the regimen used in the first line) combined either with cetuximab (experimental arm) or with bevacizumab (control arm). Treatment will be continued until disease progression, unacceptable toxicity, or withdrawal of consent. Tumor response will be assessed according to RECIST 1.1 criteria by independent central review.

The primary endpoint of the study is objective response rate (ORR). Secondary endpoints include progression-free survival (PFS), overall survival (OS), and safety profile assessed according to NCI CTCAE version 5.0. Exploratory objectives include biomarker and translational research, involving the collection and analysis of tumor tissue, blood, and stool samples to better understand resistance mechanisms and the role of the gut microbiome in treatment response.

This study builds on promising results from the earlier CAPRI and CAPRI-2 trials, which suggested that continuing cetuximab in second-line therapy may improve patient outcomes. If successful, CAPRI-3 could establish cetuximab continuation beyond first-line progression as a new treatment option for a large proportion of molecularly selected patients with metastatic colorectal cancer.

Being tested
Erbitux (Cetuximab), Bevacizumab, FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin), FOLFIRI (5-Fluorouracil, Folinic acid, Irinotecan)
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Erbitux (Cetuximab)Drug

    This is an anti-EGFR monoclonal antibody administered in combination with chemotherapy. The dose is 500 mg/m² administered every 14 days as a 120-minute intravenous infusion on cycle 1 day 1, infusion rate not faster than 5mg/min.

  • BevacizumabDrug

    This is an anti-VEGF monoclonal antibody used as an active comparator in the control arm of the study. The dose is 5 mg/kg of body weight, administered every 14 days

  • FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin)Drug

    This is a standard chemotherapy regimen containing irinotecan, fluorouracil, and folinic acid. It is used as the backbone chemotherapy in both study arms.

    The dose includes 200 mg/m2 L-folinic acid given concurrently with 85 mg/ m² oxaliplatin over 2 h IV, followed by a 400 mg/ m² IV bolus of fluorouracil followed by 2400 mg/ m² fluorouracil IV infusion every 14 days.

  • FOLFIRI (5-Fluorouracil, Folinic acid, Irinotecan)Drug

    This is a standard chemotherapy regimen containing folinic acid, oxaliplatin, and fluorouracil. It is used as the backbone chemotherapy in both study arms.

    The dose includes 200 mg/m2 L-folinic acid given concurrently with 180 mg/ m² irinotecan over 1.30 h IV infusion, followed by a 400 mg/ m² IV bolus of fluorouracil followed by 2400 mg/ m² fluorouracil IV infusion over 46 h every 14 days.

Study groups in NCT07389265
Study groupRoleWhat they receive
ARM A Chemo-doublet (FOLFIRI or FOLFOX) + CetuximabExperimentalThis arm is for participants with RAS/BRAF wild-type metastatic colorectal cancer who have progressed after first-line anti-EGFR therapy. They will receive a second-line chemotherapy regimen (either FOLFIRI or FOLFOX) in combination with cetuximab. The objective is to evaluate the efficacy of continuing cetuximab beyond progression.
Receives: Drug: Erbitux (Cetuximab); Drug: FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin); Drug: FOLFIRI (5-Fluorouracil, Folinic acid, Irinotecan)
ARM B Chemo-doublet (FOLFIRI or FOLFOX) + BevacizumabActive comparatorThis arm is for participants with RAS/BRAF wild-type metastatic colorectal cancer who have progressed after first-line anti-EGFR therapy. They will receive a second-line chemotherapy regimen (either FOLFIRI or FOLFOX) in combination with bevacizumab. This arm serves as the control group to compare the outcomes with the experimental arm.
Receives: Drug: Bevacizumab; Drug: FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin); Drug: FOLFIRI (5-Fluorouracil, Folinic acid, Irinotecan)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate (ORR)

    The primary outcome is the Objective Response Rate, which will be evaluated according to the RECIST criteria 1.1. The study aims to determine if the continuous use of cetuximab in the experimental arm results in a superior Response Rate compared to the control arm with bevacizumab.

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, or study completion whichever came first, assessed until 48 months.

Secondary outcomes (3)

  1. Overall Survival (OS)

    Time from randomization until death due to any cause. Patients alive at last follow-up will be censored at that date.

    Measured: From randomization (Day 0) until death from any cause, assessed through study completion (up to 36 months of survival follow-up)

  2. Progression-Free Survival (PFS)

    Time from randomization until the date of first documented disease progression, as assessed by central independent review according to RECIST 1.1 criteria, or death from any cause, whichever occurs first.

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months from last patient randomized.

  3. Safety Profile: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

    The safety profile of the trial drugs as measured by the incidence of AEs, SAEs, clinical laboratory assessments, vital signs, physical examination, ECG parameters, and ECOG PS.

    Measured: From first treatment administration until 30 days after the last dose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2026
  2. Study start1 Oct 2025
  3. Primary completionOct 2030 (estimated)
  4. Study completionOct 2030 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Patients will be randomized (1:1) into two arms: * Arm A: FOLFOX/FOLFIRI plus cetuximab * Arm B: FOLFOX/FOLFIRI plus bevacizumab
Masking
None (open label)
Enrolment
480 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07389265
Sponsor's protocol ID
CAPRI-3- GOIM Study
Acronym
CAPRI-3 GOIM
Status last verified
May 2025
First submitted
30 Sep 2025
Last updated
5 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Erbitux (Cetuximab), Bevacizumab and FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin) in people with Metastatic Colorectal Cancer (mCRC), run by University of Campania Luigi Vanvitelli at 41 sites in 2 countries.

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 22 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in Italy, Spain. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Fortunato Ciardiello (0815666760, fortunato.ciardiello@unicampania.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) (time frame: From date of randomization until the date of first documented progression or date of death from any cause, or study completion whichever came first, assessed until 48 months.). 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 NCT07389265.

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 5 Feb 2026.

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