Cetuximab for Cancer
Phase-Based Progress Estimates
Effectiveness
Safety
Cancer+1 More
Cetuximab - DrugEligibility
Any Age
All Sexes
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Eligibility
Any Age
All Sexes
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Study Summary
This trial is testing a new combination of drugs to treat colorectal cancer that has spread and has a certain type of abnormal gene. The new combination is encorafenib plus cetuximab, which will be taken either alone or with standard chemotherapy.
Eligible Conditions
- Cancer
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
2 Primary · 31 Secondary · Reporting Duration: Duration of Phase 3, approximately 34 months
Month 12
Safety Lead-in Study: Incidence of Dose Limiting Toxicities (DLTs)
Safety Lead-in: Duration of response by Investigator
Safety Lead-in: Incidence of abnormal clinical laboratory parameters, abnormal vital signs and abnormal electrocardiograms
Safety Lead-in: Incidence of adverse events
Safety Lead-in: Incidence of dose interruptions, dose modifications and discontinuations due to adverse events
Safety Lead-in: Overall response rate by investigator
Safety Lead-in: Overall survival
Safety Lead-in: Time to response by Investigator
Safety Lead-in:Progression free survival by Investigator
Day 28
Oxaliplatin
Safety Lead-in: Maximum plasma concentration of encorafenib, LHY746, irinotecan and SN-38
Irinotecan
Day 28
Safety Lead-in: Area under the plasma concentration time curve of encorafenib, LHY746, irinotecan and SN-38
Day 28
Safety Lead-in: Area under the plasma concentration time curve of encorafenib, LHY746 and oxaliplatin
Safety Lead-in: Maximum plasma concentration of encorafenib, LHY746 and oxaliplatin
Safety Lead-in: Time to maximim plasma concentration time curve of encorafenib, LHY746 and oxaliplatin
Month 34
Phase 3: Change from Baseline in the EuroQol-5D-5L (EQ-5D-5L) Questionnaire
Phase 3: Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)
Phase 3: Change from Baseline in the Patient Global Impression of Change (PGIC) questionnaires
Phase 3: Change from Baseline in the Patient Global Impression of Severity (PGIS)
Phase 3: Duration of response by blinded independent review and by Investigator
Phase 3: Incidence of abnormal clinical laboratory parameters, abnormal vital signs and abnormal electrocardiograms
Phase 3: Incidence of adverse events
Phase 3: Overall response rate by blinded independent review and by Investigator
Phase 3: Overall survival
Phase 3: Overall survival and Progression free survival by blinded independent review
Phase 3: Progression free survival 2 by Investigator
Phase 3: Progression free survival by Investigator
Phase 3: Progression free survival, by blinded independent review
Phase 3: Time to response by blinded independent review and by Investigator
Once, pre-treatment
Phase 3: Confirm the MSI-status in tumor tissue
Day 28
Phase 3: Determine the correlation between cfDNA genetic alterations and clinical outcome
Day 28
Phase 3: Trough concentrations of encorafenib and its metabolite LHY746
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
5 Treatment Groups
Phase 3 Arm C
1 of 5
Phase 3 Arm B
1 of 5
Safety Lead-in Cohort 1
1 of 5
Safety Lead-in Cohort 2
1 of 5
Phase 3 Arm A
1 of 5
Active Control
Experimental Treatment
765 Total Participants · 5 Treatment Groups
Primary Treatment: Cetuximab · No Placebo Group · Phase 3
Phase 3 Arm BExperimental Group · 6 Interventions: Irinotecan, Oxaliplatin, Leucovorin, Cetuximab, Encorafenib, 5-FU · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug
Safety Lead-in Cohort 1Experimental Group · 5 Interventions: Irinotecan, Leucovorin, Cetuximab, Encorafenib, 5-FU · Intervention Types: Drug, Drug, Drug, Drug, Drug
Safety Lead-in Cohort 2Experimental Group · 5 Interventions: Oxaliplatin, Leucovorin, Cetuximab, Encorafenib, 5-FU · Intervention Types: Drug, Drug, Drug, Drug, Drug
Phase 3 Arm AExperimental Group · 2 Interventions: Cetuximab, Encorafenib · Intervention Types: Drug, Drug
Phase 3 Arm CActiveComparator Group · 6 Interventions: Irinotecan, Oxaliplatin, Bevacizumab, Leucovorin, Capecitabine, 5-FU · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Irinotecan
FDA approved
Oxaliplatin
FDA approved
Levoleucovorin
FDA approved
Cetuximab
FDA approved
Encorafenib
FDA approved
Fluorouracil
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: duration of phase 3, approximately 34 months
Who is running the clinical trial?
Ono Pharmaceutical Co. LtdIndustry Sponsor
148 Previous Clinical Trials
94,136 Total Patients Enrolled
Merck KGaA, Darmstadt, GermanyIndustry Sponsor
428 Previous Clinical Trials
112,141 Total Patients Enrolled
PfizerLead Sponsor
4,260 Previous Clinical Trials
7,104,154 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,248 Previous Clinical Trials
4,819,834 Total Patients Enrolled
Eligibility Criteria
Age Any Age · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have BRAF V600E mutation.
You are 16 years old or older.
You are at least 18 years old.
You have no phase 3.\n
You have received adjuvant or neoadjuvant therapy for metastatic disease.
You have adequate organ function.
About The Reviewer
Michael Gill - B. Sc.
First Published: October 19th, 2021
Last Reviewed: November 12th, 2022
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
Who else is applying?
What state do they live in?
| Missouri | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Siteman Cancer Center - North County | 50.0% |
| Barnes- Jewish Hospital | 50.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 50.0% |
| Did not meet criteria | 50.0% |
How responsive is this trial?
Most responsive sites:
- Barnes- Jewish Hospital: < 48 hours
Typically responds via
| 100.0% | |
Average response time
- < 2 Days
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