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Monoclonal Antibodies

Encorafenib + Cetuximab for Colorectal Cancer

Phase 3
Recruiting
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically or cytologically confirmed Stage IV CRC that contains BRAF V600E mutation
Prior systemic treatment in metastatic setting
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of phase 3, approximately 50 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial

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.

Who is the study for?
This trial is for adults with Stage IV colorectal cancer that has spread and has a specific gene mutation (BRAF V600E). They should not have had previous treatments for metastatic cancer, although prior adjuvant therapy is allowed if relapse occurred within 6 months. Participants need to be in good physical condition with proper organ function and no symptomatic brain metastases or recent infections.Check my eligibility
What is being tested?
The study tests encorafenib plus cetuximab alone or combined with standard chemotherapy (Oxaliplatin, Irinotecan, Bevacizumab, Leucovorin, Capecitabine, 5-FU) against chemotherapy alone. Encorafenib is taken orally daily; cetuximab is given by IV every two weeks. The goal is to compare the effectiveness of these treatments over approximately three years.See study design
What are the potential side effects?
Potential side effects include reactions at the infusion site from cetuximab or chemotherapy drugs, skin problems from encorafenib and cetuximab, digestive issues like nausea or diarrhea from all medications involved, increased risk of infection due to lowered immunity especially from chemotherapy agents.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My colorectal cancer is stage IV with a BRAF V600E mutation.
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I have received systemic treatment for cancer that has spread.
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I have had up to one previous systemic therapy.
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I am eligible for a Phase 3 trial with no specific requirements.
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I am 18 years old or older.
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I am 16 years old or older.
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My colorectal cancer is stage IV with a BRAF V600E mutation.
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I have received treatment for cancer after it spread.
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I have been treated with up to 1 type of therapy for my condition.
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I am eligible for a Phase 3 trial with no specific requirements.
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My cancer returned within 6 months after completing early-stage treatment.
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My cancer can be measured or evaluated by tests.
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I am fully active or can carry out light work.
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My organs are working well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of phase 3, approximately 50 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of phase 3, approximately 50 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cohort 3: Objective response rate by blinded independent review
Phase 3: Objective response rate by blinded independent review
Phase 3: Progression free survival, by blinded independent review
+1 more
Secondary outcome measures
Cohort 3: Change from Baseline in the EuroQol-5D-5L (EQ-5D-5L) Questionnaire
Cohort 3: Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)
Cohort 3: Change from Baseline in the Patient Global Impression of Change (PGIC) questionnaires
+41 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

7Treatment groups
Experimental Treatment
Active Control
Group I: Safety Lead-in Cohort 2Experimental Treatment5 Interventions
Encorafenib 300 mg orally once daily Cetuximab 500 mg/m2 (120 minute IV infusion) every two weeks Oxaliplatin 85 mg/m2 (120-minute IV infusion) every two weeks Leucovorin 400 mg/m2 (120-minute IV infusion) every two weeks 5-FU 400 mg/m2 IV bolus, then 5-FU 2400 mg/m2 continuous IV infusion over 46-48 hours every two weeks
Group II: Safety Lead-in Cohort 1Experimental Treatment5 Interventions
Encorafenib 300 mg orally once daily Cetuximab 500 mg/m2 (120-minute IV infusion) every two weeks Irinotecan 180 mg/m2 (90-minute IV infusion) every two weeks Leucovorin 400 mg/m2 (120-minute IV infusion) every two weeks 5-FU 400 mg/m2 IV bolus, then 5-FU 2400 mg/m2 continuous IV infusion over 46-48 hours every two weeks
Group III: Phase 3 Arm BExperimental Treatment6 Interventions
Encorafenib 300 mg orally once daily Cetuximab 500 mg/m2 (120 minute IV infusion) every two weeks Oxaliplatin 85 mg/m2 (120-minute IV infusion) every two weeks Leucovorin 400 mg/m2 (120-minute IV infusion) every two weeks 5-FU 400 mg/m2 IV bolus, then 5-FU 2400 mg/m2 continuous IV infusion over 46-48 hours every two weeks
Group IV: Phase 3 Arm AExperimental Treatment2 Interventions
Encorafenib 300 mg orally once daily Cetuximab 500 mg/m2 (120-minute IV infusion) every two weeks
Group V: Cohort 3 Arm DExperimental Treatment5 Interventions
Encorafenib 300 mg orally once daily Cetuximab 500 mg/m2 (120-minute IV infusion) every two weeks Irinotecan 180 mg/m2 (90-minute IV infusion) every two weeks Leucovorin 400 mg/m2 (120-minute IV infusion) every two weeks 5-FU 400 mg/m2 IV bolus, then 5-FU 2400 mg/m2 continuous IV infusion over 46-48 hours every two weeks
Group VI: Phase 3 Arm CActive Control6 Interventions
Every two weeks: Oxaliplatin 85 mg/m2 (120-minute IV infusion) Leucovorin 400 mg/m2 (120-minute IV infusion) 5-FU 400 mg/m2 IV bolus, then 5-FU 2400 mg/m2 continuous IV infusion over 46-48 hours Bevacizumab (optional; given per prescribing instructions) -OR- Every two weeks: Irinotecan 165 mg/m2 (90-minute IV infusion) Oxaliplatin 85 mg/m2 (120-minute IV infusion) Leucovorin 400 mg/m2 (120-minute IV infusion) 5-FU 2400 or 3200 mg/m2 continuous IV infusion over 46 48 hours Bevacizumab (optional; given per prescribing instructions) -OR- Oxaliplatin 130 mg/m2 (120-minute IV infusion) every 3 weeks Capecitabine 1000 mg/m2 oral tablet twice daily on Days 1-14 Bevacizumab (optional; given per prescribing instructions)
Group VII: Cohort 3 Arm EActive Control4 Interventions
Irinotecan 180 mg/m2 (90-minute IV infusion) every 2 weeks, Leucovorin 400 mg/m2 (120-minute IV infusion) every 2 weeks, 5-FU 400 mg/m2 IV bolus, then 5-FU 2400 mg/m2 continuous IV infusion over 46-48 hours every two weeks, Bevacizumab (optional; given per prescribing instructions)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxaliplatin
2011
Completed Phase 4
~2560
Irinotecan
2017
Completed Phase 4
~2680
Leucovorin
2005
Completed Phase 4
~5730
Cetuximab
2011
Completed Phase 3
~2480
Encorafenib
2021
Completed Phase 3
~960
5-FU
2014
Completed Phase 3
~3420

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyIndustry Sponsor
2,597 Previous Clinical Trials
3,185,364 Total Patients Enrolled
3 Trials studying Tumors
1,585 Patients Enrolled for Tumors
PfizerLead Sponsor
4,545 Previous Clinical Trials
11,421,956 Total Patients Enrolled
4 Trials studying Tumors
1,873 Patients Enrolled for Tumors
Ono Pharmaceutical Co. LtdIndustry Sponsor
154 Previous Clinical Trials
93,854 Total Patients Enrolled

Media Library

Cetuximab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04607421 — Phase 3
Tumors Research Study Groups: Safety Lead-in Cohort 1, Safety Lead-in Cohort 2, Phase 3 Arm A, Phase 3 Arm B, Phase 3 Arm C, Cohort 3 Arm D, Cohort 3 Arm E
Tumors Clinical Trial 2023: Cetuximab Highlights & Side Effects. Trial Name: NCT04607421 — Phase 3
Cetuximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04607421 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are included in the scope of this research?

"The sponsor, Ono Pharmaceutical Co. Ltd., needs to recruit 765 patients that fit the clinical study's inclusion criteria from locations including The University of Chicago Medicine Center for Advanced Care Orland Park in Orland Park, Illinois and UChicago Medicine at Ingalls - Tinley Park in Tinley Park, Ontario."

Answered by AI

What is the official government stance on Cetuximab?

"Cetuximab has received a 3 for safety from our Power team. This is due to the fact that it is a Phase 3 trial, which means that there is not only some data supporting efficacy, but multiple rounds of data affirming its safety."

Answered by AI

What are the conditions that Cetuximab is most commonly used to target?

"Cetuximab can be used as a treatment for small cell lung cancer, unresectable melanoma, and rectal carcinoma."

Answered by AI

In how many total places is this research being conducted?

"There are 100 clinical trial sites operational for this study, including The University of Chicago Medicine Center for Advanced Care Orland Park in Orland Park, UChicago Medicine at Ingalls - Tinley Park in Tinley Park, and London Regional Cancer Program, London Health Sciences Centre in London."

Answered by AI

Are researchers still looking for volunteers for this clinical trial?

"Yes, this is an ongoing study that is recruiting patients from 100 different sites. The trial was posted on December 21st 2020 and the most recent update was on October 4th, 2022. They are looking to enroll 765 people in total."

Answered by AI

What does the research say about Cetuximab's efficacy?

"Cetuximab is being trialed in 1275 active studies, with the majority of Phase 3 trials taking place in Guangzhou, Guangdong. In total, there are 51069 locations worldwide where Cetuximab clinical trials are running."

Answered by AI

Who else is applying?

What state do they live in?
Missouri
How old are they?
18 - 65
What site did they apply to?
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Siteman Cancer Center - North County
Barnes- Jewish Hospital
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

Why did patients apply to this trial?

I’ve been in standard care for chemotherapy and now in my 13 round of chemo but my metastasized tumors in my lung and liver still progressing. I am seeking treatment options that could minimize side effect like neuropathy since my oncologist told me I will be in maintenance therapy for the rest of my life.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Barnes- Jewish Hospital: < 48 hours
Average response time
  • < 2 Days
~142 spots leftby Nov 2024