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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
Must not have
Symptomatic brain metastases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of phase 3, approximately 50 months
Awards & highlights

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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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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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have brain metastases that are causing symptoms.

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

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
2022
Completed Phase 3
~970
5-FU
2014
Completed Phase 3
~3420

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyIndustry Sponsor
2,629 Previous Clinical Trials
3,217,295 Total Patients Enrolled
3 Trials studying Tumors
1,585 Patients Enrolled for Tumors
PfizerLead Sponsor
4,595 Previous Clinical Trials
12,867,955 Total Patients Enrolled
4 Trials studying Tumors
1,873 Patients Enrolled for Tumors
Ono Pharmaceutical Co. LtdIndustry Sponsor
154 Previous Clinical Trials
93,708 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
~53 spots leftby Nov 2024
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