Colorectal CancerPhase 2BRICKETNCT06578559
Phase II Study of ctDNA-guided Encorafenib Plus Cetuximab Retreatment in Patients BRAF V600E Mutated mCRC
A Phase 2 study testing Cetuximab and Encorafenib in people with Colorectal Cancer, run by Gruppo Oncologico del Nord-Ovest at 13 sites in Italy.
Trial summary
The aim of this study is to evaluate the activity, in terms of best response according to RECIST criteria 1.1 as assessed by the local investigator, of the ctDNA-guided retreatment with encorafenib plus cetuximab in BRAFV600E mutated mCRC patients experiencing benefit from previous exposure to encorafenib plus… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Cetuximab and Encorafenib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 13 sitesItaly
- Study dates
- 23 Jul 2024to 20 Oct 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically proven diagnosis of colorectal adenocarcinoma;
- age ≥ 18 years;
- ECOG Performance status ≤ 1;
- BRAFV600E mutated status of primary colorectal cancer and/or related metastasis, by local laboratory assessment according to standard procedures by means of molecular assay on genomic DNA;
- Metastatic disease with at least one measurable lesion according to RECIST 1.1. criteria;
- previous treatment with encorafenib plus cetuximab with or without chemotherapy (i.e., ±FOLFOX/FOLFIRI) in any line, producing a RECIST 1.1 complete/partial response or disease stabilisation, with a PFS of this treatment lasting at least 6 months;
Show all 26Show fewer
- documentation of RECIST 1.1 disease progression during or after the end of the previous exposure to encorafenib plus cetuximab ± chemotherapy;
- one intervening line of treatment not including any BRAF and EGFR inhibitor, between the end of first exposure to encorafenib plus cetuximab ± chemotherapy and the time of screening;
- at least 4 months elapsed between the end of the previous exposure to encorafenib plus cetuximab ± chemotherapy and the retreatment with encorafenib plus cetuximab;
- previous treatment with immune checkpoint inhibitors (anti-PD-1/PD-L1 alone or in combination with anti-CTLA-4 agent), in the case of MSI-H or dMMR mCRC;
- availability of blood sample for ctDNA analysis within 28 days prior enrolment;
- BRAFV600E mutated status of ctDNA at screening (central laboratory assessment by means of GUARDANT360 CDx, Guardant Health);
- KRAS, NRAS, MAP2K1 wild-type status and MET not amplified status in ctDNA at screening (central laboratory assessment by means of GUARDANT360 CDx, Guardant Health);
- Availability of archival tumour tissue (primary tumour and/or metastases) for biomarker analysis;
- neutrophils >1.5 x 109/L, Platelets >100 x 109/L, Hgb >9 g/dl. Transfusions will be permitted provided the patient has not received more than two units red blood cells in the prior 4 weeks to achieve this criterion.
- adequate renal function characterised by serum creatinine ≤ 1.5 × upper limit of normal (ULN), or calculated by Cockroft-Gault formula or directly measured creatinine clearance ≥ 50 mL/min at screening;
- adequate hepatic function characterised by the following at screening: Serum total bilirubin ≤ 1.5 × ULN and < 2 mg/dL. Note: Patients who have a total bilirubin level > 1.5 × ULN will be allowed if their indirect bilirubin level is ≤ 1.5 × ULN; Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤ 2.5 × ULN, or ≤ 5 × ULN in presence of liver metastases. In the presence of documented Gilbert's syndrome, a value of total bilirubin < 3 × ULN is acceptable.
- adequate electrolytes at baseline, defined as serum potassium and magnesium levels within institutional normal limits (Note: replacement treatment to achieve adequate electrolytes will be allowed).
- INR or aPTT ≤ 1.5 × ULN;
- QT interval corrected for heart rate ≤480 msec at screening;
- ability to take oral medications;
- women of childbearing potential must have a negative blood pregnancy test at the screening. For this trial, women of childbearing potential are defined as all women after puberty, unless they are postmenopausal for at least twelve continuous months, are surgically sterile, or are sexually inactive. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient;
- subjects and their partners must be willing to avoid pregnancy from the study screening until 1 month after the last trial treatment. Male subjects with female partners of childbearing potential and female subjects of childbearing potential must, therefore, be willing to use adequate contraception as approved by the investigator. Encorafenib may decrease the efficacy of hormonal contraceptives. Therefore, female patients using hormonal contraception are advised to use an additional or alternative method such as a barrier method (i.e., condom) from the screening phase for at least 1 month following the last dose of study treatment. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject;
- written informed consent to study procedures;
- life expectancy of at least twelve weeks;
- will and ability to comply with the protocol.
Who cannot join
- Known hypersensitivity or contraindications to trial drugs or any component of the trial drugs;
- discontinuation of previous treatment with encorafenib and/or cetuximab with or without chemotherapy due to encorafenib- and/or cetuximab-related adverse events;
- symptomatic brain metastases or spinal cord compression. Notes: Patients previously treated or untreated for these conditions who are asymptomatic in the absence of corticosteroid and anti-epileptic therapy are allowed. Brain metastases or spinal cord compression must be stable for ≥ 4 weeks, with imaging (e.g., magnetic resonance imaging [MRI] or computed tomography [CT]) demonstrating no current evidence of progressive brain metastases or spinal cord compression at screening;
- leptomeningeal disease;
- other co-existing malignancies or malignancies diagnosed within the last 5 years except for adequately treated localised basal and squamous cell carcinoma or cervical cancer in situ;
- treatment with any investigational drug within 30 days prior to enrolment or two investigational agent half-lives (whichever is longer);
Show all 20Show fewer
- Impaired gastrointestinal function (i.e., uncontrolled nausea, vomiting or diarrhea, malabsorption syndrome, small bowel resection) or disease which may significantly alter the absorption of oral study intervention or recent changes in bowel function suggesting current or impending bowel obstruction;
- use of any herbal medications/supplements or any medications or foods that are moderate or strong inhibitors or inducers of CYP3A4/5 ≤1 week prior to the start of treatment;
- diagnosis of interstitial pneumonitis or pulmonary fibrosis;
- known history of acute or chronic pancreatitis within 6 months prior to the start of the treatment;
- history of chronic inflammatory bowel disease or Crohn's disease requiring medical intervention immunomodulatory or immunosuppressive medications or surgery) ≤12 months prior to first dose;
- impaired hepatic function, defined as Child-Pugh class B or C;
- clinically significant cardiovascular diseases, including any of the following:
- history of acute myocardial infarction, acute coronary syndromes (including unstable angina, coronary artery bypass graft, coronary angioplasty or stenting) ≤6 months prior to registration;
- congestive heart failure requiring treatment (New York Heart Association Class II and above);
- recent history (within 1 year prior to registration) or presence of clinically significant cardiac arrhythmias (including uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia);
- QT interval corrected for heart rate >480 msec at screening and rate uncontrolled atrial fibrillation and paroxysmal supraventricular tachycardia;
- pregnant or lactating women. Women of childbearing potential with either a positive or no pregnancy test at baseline. Postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential. Sexually active males and females (of childbearing potential) unwilling to practice contraception (barrier contraceptive measure or oral contraception) from the screening phase until 1 month after the last trial treatment;
- residual CTCAE ≥ Grade 2 toxicity from any prior anticancer therapy, with the exception of grade 2 alopecia or grade 2 neuropathy
- active eye disorders, including keratitis, ulcerative keratitis or severe dry eye.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Italy13 sites
Istituto Romagnolo Per Lo Studio Dei Tumori "Dino Amadori" Irccs Irst
Meldola, FC, 47014
IRCCS Istituto Nazionale dei Tumori di Milano
Milan, MI, 20133
L'Azienda Ospedaliero Universitaria di Cagliari
Monserrato, CA, 09042
Azienda Ospedaliera Universitaria degli Studi di Campania L. Vanvitelli
Naples, 80131
Istituto Oncologico Veneto Irccs
Padova, PD, 35128
Azienda Ospedaliero-Universitaria Pisana
Pisa, PI, 56126
Nuovo Ospedale di Prato S. STEFANO
Prato, PO, 59100
AUSL Romagna
Ravenna, RA, 48121
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, RM, 00168
Fondazione Casa Sollievo Della Sofferenza - Irccs
San Giovanni Rotondo, FG, 71013
Pia Fondazione di Culto e di Religione Cardinale G. Panico
Tricase, LE, 73039
A.O.U. Citta Della Salute E Della Scienza Di Torino Presidio Molinette
Turin, TO, 10126
Azienda Sanitaria Universitaria Friuli Centrale
Udine, UD, 33100
About this study
Official title: Single Arm Phase II Study of ctDNA-guided Encorafenib Plus Cetuximab Retreatment in Patients With BRAF V600E Mutated mCRC (BRICKET)
The aim of this study is to evaluate the activity, in terms of best response according to RECIST criteria 1.1 as assessed by the local investigator, of the ctDNA-guided retreatment with encorafenib plus cetuximab in BRAFV600E mutated mCRC patients experiencing benefit from previous exposure to encorafenib plus cetuximab (+/- chemotherapy) and with BRAFV600E mutated, KRAS, NRAS and MAP2K1 wild-type and MET not amplified status on ctDNA at the time of study entry.
Read the detailed description
This is a proof-of-concept, multicenter, open-label, single arm one-stage phase II trial of a ctDNA-guided retreatment with encorafenib plus cetuximab for mCRC patients bearing the BRAFV600E mutation and with the key following characteristics:
- initial benefit and then secondary resistance to a previous exposure to encorafenib and cetuximab with or without chemotherapy;
- only one subsequent intervening anti-BRAF and anti-EGFR-free line of therapy;
- confirmed BRAFV600E mutated status and no detectable mutations in KRAS, NRAS, MAP2K1 and no amplification of MET in ctDNA at the time of retreatment;
Eligible patients will receive Encorafenib 300 mg once daily (four 75 mg oral capsules) and Cetuximab 500 mg/sqm iv infusion every 14 days.Treatment will be delivered in 28-day cycles until disease progression, unacceptable toxic effects, withdrawal of consent, initiation of subsequent anticancer therapy, or death.
- Conditions
- Colorectal Cancer
- Being tested
- Cetuximab, Encorafenib
- Keywords
- ctDNA, Encorafenib, Cetuximab, rechallenge, retreatment, BRAF V600E
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
500 mg/sqm intravenous infusion over 120-minute at cycle 1 (if well tolerated, it is administered over 90 minutes at second administration, and over 60 minutes by the third administration) every 14 days.
EncorafenibDrug
300 mg once daily (four 75 mg oral capsules).
| Study group | Role | What they receive |
|---|---|---|
| Encorafenib + Cetuximab | Experimental | Not described Receives: Drug: Cetuximab; Drug: Encorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
The percentage of patients, relative to the total of enrolled subjects, achieving a complete (CR) or partial (PR) response, according to RECIST 1.1 criteria. The determination of clinical response will be based on investigator-reported measurements.
Responses will be evaluated with a total body computed tomography (CT) scan every 8 weeks.
Measured: 8 months after the enrollment of the last patient.
Secondary outcomes (12)
Progression Free Survival (PFS)
The time interval computed from the date of study enrollment to the date of objective progression according to the RECIST criteria (version 1.1) or death, whatever comes first.
Patients alive and free of progression prior to the analysis cut-off date are censored at the date of the last disease assessment.
Measured: 8 months after the enrollment of the last patient.
Overall Survival (OS)
The time from the date of study enrollment to the date of death due to any cause. For patients still alive at the time of analysis, the OS time will be censored on the last date the patients were known to be alive.
Measured: 8 months after the enrollment of the last patient.
Overall Toxicity Rate
The percentage of patients, relative to the total of enrolled subjects, experiencing any adverse event, according to National Cancer Institute Common Toxicity Criteria (CTCAE version 5.0).
The CTCAE are classified as Grades 1 to 5 (from milder to more severe symptoms).
Measured: 8 months after the enrollment of the last patient.
Grade 3/4 Toxicity Rate
The percentage of patients, relative to the total of enrolled subjects, experiencing a specific adverse event of grade 3/4, according to National Cancer Institute Common Toxicity Criteria (CTCAE version 5.0).
The CTCAE are classified as Grades 1 to 5 (from milder to more severe symptoms).
Measured: 8 months after the enrollment of the last patient.
Early Objective Response Rate (EORR)
The percentage of patients, relative to the total of the enrolled subjects, achieving at least a 20% decrease in the sum of diameters of RECIST target lesions at week 8 compared to baseline.
Measured: 8 months after the enrollment of the last patient.
Depth of Response (DpR)
The relative change in the sum of longest diameters of RECIST target lesions at the nadir, in the absence of new lesions or progression of non-target lesions, when compared with baseline.
Measured: 8 months after the enrollment of the last patient.
Objective Response Rate in the screening failure population (ORR-failure)
Best objective response according to RECIST 1.1 criteria of the first line after ctDNA screening failure, if administered.
Measured: 8 months after the enrollment of the last patient.
Progression Free Survival in the screening failure population (PFS-failure)
The time interval computed from the start of the first treatment after ctDNA screening failure, if delivered, to the date of objective progression according to the RECIST criteria (version 1.1) or death, whichever comes first.
Measured: 8 months after the enrollment of the last patient.
Overall Survival in the screening failure population (OS-failure)
The time interval computed from the start of the first treatment after ctDNA screening failure, if delivered, to the date of death due to any cause. For patients still alive at the time of analysis, the OS time will be censored on the last date the patients were known to be alive.
Measured: 8 months after the enrollment of the last patient.
Quality of Life as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
The EORTC QLQ-C30 contains functional scales, symptom scales, single items scale and a global health status/QoL scale. Raw scores are standardized and converted into scale scores ranging from 0 to 100.
Higher scores represent better functioning on the functional scales and a higher level of symptoms on the symptom scales.
Quality of life will be evaluated for patients who will have completed at least one questionnaire item at baseline and during the study period through descriptive summary statistics.
Measured: Questionnaires will be administered at baseline (cycle 1 day 1), every 8 weeks thereafter, at disease progression and after 30 days following end of study treatment.
Quality of Life as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Module for Colorectal cancer 29 (EORTC QLQ-CR29).
The EORTC QLQ-CR29 includes 29 items that evaluate symptoms (gastrointestinal, urinary, pain and others) and functional areas (sexual, body image and others) that are associated with CRC and its treatments.
There are separate items for patients with and without a stoma and separate items to evaluate the sexual function of men and women. Raw scores are standardized and converted into scale scores ranging from 0 to 100. Higher scores represent better functioning on the functional scales and a higher level of symptoms on the symptom scales.
Quality of life will be evaluated for patients who will have completed at least one questionnaire item at baseline and during the study period through descriptive summary statistics.
Measured: Questionnaires will be administered at baseline (cycle 1 day 1), every 8 weeks thereafter, at disease progression and after 30 days following end of study treatment.
Time To Deterioration in Quality of Life (TTD)
The time from baseline to the first onset of a 10-point or greater decrease from study enrollment for functional scales or a 10-point or greater increase for symptom scales or death.
Measured: 8 months after the enrollment of the last patient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start23 Jul 2024
- Primary completion12 May 2026
- Study completion20 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gruppo Oncologico del Nord-Ovest
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Pierre Fabre Laboratories
- Responsible party
- Sponsor
- Investigators
- Carlotta Antoniotti, MD, PhD, Principal investigator, Department of Translational Research and New Technologies in Medicine and Surgery - University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06578559
- Sponsor's protocol ID
- BRICKET
- Acronym
- BRICKET
- Status last verified
- Oct 2026
- First submitted
- 29 Jul 2024
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Arm Phase II Study of ctDNA-guided Encorafenib Plus Cetuximab Retreatment in Patients With BRAF V600E Mutated mCRC (BRICKET)
- ClinicalTrials.gov ID
- NCT06578559
- Acronym / sponsor ID
- BRICKET / BRICKET
- Conditions
- Colorectal Cancer
- Keywords
- ctDNA, Encorafenib, Cetuximab, rechallenge, retreatment, BRAF V600E
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Gruppo Oncologico del Nord-OvestUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC, Pierre Fabre Laboratories
- Study start
- 23 Jul 2024 (actual)
- Primary completion
- 12 May 2026 (actual)
- Study completion
- 20 Oct 2026 (actual)
- First posted
- 29 Aug 2024 (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.
The aim of this study is to evaluate the activity, in terms of best response according to RECIST criteria 1.1 as assessed by the local investigator, of the ctDNA-guided retreatment with encorafenib plus cetuximab in BRAFV600E mutated mCRC patients experiencing benefit from previous exposure to encorafenib plus cetuximab (+/- chemotherapy) and with BRAFV600E mutated, KRAS, NRAS and MAP2K1 wild-type and MET not amplified status on ctDNA at the time of study entry.
Detailed description
This is a proof-of-concept, multicenter, open-label, single arm one-stage phase II trial of a ctDNA-guided retreatment with encorafenib plus cetuximab for mCRC patients bearing the BRAFV600E mutation and with the key following characteristics:
- initial benefit and then secondary resistance to a previous exposure to encorafenib and cetuximab with or without chemotherapy;
- only one subsequent intervening anti-BRAF and anti-EGFR-free line of therapy;
- confirmed BRAFV600E mutated status and no detectable mutations in KRAS, NRAS, MAP2K1 and no amplification of MET in ctDNA at the time of retreatment;
Eligible patients will receive Encorafenib 300 mg once daily (four 75 mg oral capsules) and Cetuximab 500 mg/sqm iv infusion every 14 days.Treatment will be delivered in 28-day cycles until disease progression, unacceptable toxic effects, withdrawal of consent, initiation of subsequent anticancer therapy, or death.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Encorafenib + Cetuximab | Experimental | Drug: Cetuximab, Drug: Encorafenib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- histologically proven diagnosis of colorectal adenocarcinoma;
- age ≥ 18 years;
- ECOG Performance status ≤ 1;
- BRAFV600E mutated status of primary colorectal cancer and/or related metastasis, by local laboratory assessment according to standard procedures by means of molecular assay on genomic DNA;
- Metastatic disease with at least one measurable lesion according to RECIST 1.1. criteria;
Key exclusion criteria (20 listed)
- Known hypersensitivity or contraindications to trial drugs or any component of the trial drugs;
- discontinuation of previous treatment with encorafenib and/or cetuximab with or without chemotherapy due to encorafenib- and/or cetuximab-related adverse events;
- symptomatic brain metastases or spinal cord compression. Notes: Patients previously treated or untreated for these conditions who are asymptomatic in the absence of corticosteroid and anti-epileptic therapy are allowed. Brain metastases or spinal cord compression must be stable for ≥ 4 weeks, with imaging (e.g., magnetic resonance imaging [MRI] or computed tomography [CT]) demonstrating no current evidence of progressive brain metastases or spinal cord compression at screening;
- leptomeningeal disease;
- other co-existing malignancies or malignancies diagnosed within the last 5 years except for adequately treated localised basal and squamous cell carcinoma or cervical cancer in situ;
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 |
|---|---|---|
| Cetuximab500 mg/sqm intravenous infusion over 120-minute at cycle 1 (if well tolerated, it is administered over 90 minutes at second administration, and over 60 minutes by the third administration) every 14 days. | Drug | Encorafenib + Cetuximab |
| Encorafenib300 mg once daily (four 75 mg oral capsules). | Drug | Encorafenib + Cetuximab |
Primary outcome
Objective Response Rate (ORR)
Time frame: 8 months after the enrollment of the last patient.
The percentage of patients, relative to the total of enrolled subjects, achieving a complete (CR) or partial (PR) response, according to RECIST 1.1 criteria. The determination of clinical response will be based on investigator-reported measurements. Responses will be evaluated with a total body computed tomography (CT) scan every 8 weeks.
12 secondary outcomes
Progression Free Survival (PFS)
Time frame: 8 months after the enrollment of the last patient.
Overall Survival (OS)
Time frame: 8 months after the enrollment of the last patient.
Overall Toxicity Rate
Time frame: 8 months after the enrollment of the last patient.
Grade 3/4 Toxicity Rate
Time frame: 8 months after the enrollment of the last patient.
Early Objective Response Rate (EORR)
Time frame: 8 months after the enrollment of the last patient.
Depth of Response (DpR)
Time frame: 8 months after the enrollment of the last patient.
Objective Response Rate in the screening failure population (ORR-failure)
Time frame: 8 months after the enrollment of the last patient.
Progression Free Survival in the screening failure population (PFS-failure)
Time frame: 8 months after the enrollment of the last patient.
Overall Survival in the screening failure population (OS-failure)
Time frame: 8 months after the enrollment of the last patient.
Quality of Life as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30).
Time frame: Questionnaires will be administered at baseline (cycle 1 day 1), every 8 weeks thereafter, at disease progression and after 30 days following end of study treatment.
Quality of Life as assessed by the European Organization for Research and Treatment of Cancer Quality of Life Module for Colorectal cancer 29 (EORTC QLQ-CR29).
Time frame: Questionnaires will be administered at baseline (cycle 1 day 1), every 8 weeks thereafter, at disease progression and after 30 days following end of study treatment.
Time To Deterioration in Quality of Life (TTD)
Time frame: 8 months after the enrollment of the last patient.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
Carlotta Antoniotti, MD, PhD principal investigator
Department of Translational Research and New Technologies in Medicine and Surgery - University of Pisa
13 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 Cetuximab and Encorafenib in people with Colorectal Cancer, run by Gruppo Oncologico del Nord-Ovest at 13 sites in Italy.
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 26 inclusion and 20 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: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: 8 months after the enrollment of the last patient.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Oct 2026.