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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

Pivotal Trial

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ duration of phase 3, approximately 50 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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

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

~2890

Irinotecan

2017

Completed Phase 3

~2590