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Monoclonal Antibodies

Encorafenib + Cetuximab + Nivolumab for Colorectal Cancer

Phase 1 & 2

Waitlist Available

Led By Van K Morris

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Serum Creatinine ≤ 1.5 x ULN, or calculated creatinine clearance (determined as per Cockcroft-Gault) ≥ 50mL/min at screening;

Histologically (or cytologically) confirmed diagnosis of adenocarcinoma of the colon or rectum, with clinical confirmation of unresectable and/or metastatic disease that is measurable according to RECIST1.1 criteria.

Must not have

Impaired gastrointestinal function or disease that may significantly alter the absorption of study drug (e.g., ulcerative diseases, uncontrolled vomiting, malabsorption syndrome, small bowel resection with decreased intestinal absorption)

Uncontrolled hypertension defined as persistent elevation of systolic blood pressure ≥ 170 mmHg or diastolic blood pressure ≥ 100 mm Hg, despite current therapy;

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of drugs to treat patients with colorectal cancer that has spread and cannot be removed by surgery. The drugs work by blocking enzymes needed for cell growth and by helping the body's immune system attack the cancer.

Who is the study for?

Adults with microsatellite stable, BRAFV600E mutated colorectal cancer that's inoperable or has spread can join. They must be able to take pills, have certain blood and organ function levels, not be pregnant or fathering a child, and agree to use contraception. Exclusions include HIV, hepatitis B/C infection, uncontrolled hypertension, recent live vaccines, certain heart conditions, brain metastases symptoms.

What is being tested?

The trial is testing the combination of encorafenib (blocks enzymes for cell growth), cetuximab (stops tumor cells), and nivolumab (boosts immune attack on cancer) in patients with specific colorectal cancer. It aims to find the best dose and observe side effects compared to using cetuximab alone.

What are the potential side effects?

Potential side effects may include allergic reactions due to monoclonal antibodies like nivolumab and cetuximab; skin issues from encorafenib; plus common chemotherapy-related effects such as fatigue, digestive problems, blood disorders which could affect organ functions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function, measured by creatinine levels, is within the normal range.

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My colon or rectum cancer is confirmed, cannot be surgically removed, and can be measured.

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My tumor has the BRAFV600E mutation as confirmed by a certified lab.

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My cancer is microsatellite stable (MSS) as confirmed by a certified lab.

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I am fully active and can carry on all my pre-disease activities without restriction.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My stomach or intestines do not work well, affecting how I absorb medicine.

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My blood pressure is very high despite taking medication.

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I have had a transplant of tissue or an organ from another person.

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I have previously received immunotherapy for cancer treatment.

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I have had a severe allergic reaction to certain antibody treatments.

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I am currently taking antibiotics for an infection.

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My cancer has spread to the lining of my brain and spinal cord.

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My heart health is good and I don't have major heart diseases.

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I haven't had a heart attack or any major heart procedure in the last 6 months.

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I have not had major surgery in the last 6 weeks or still have side effects from it.

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I have had pneumonitis treated with steroids.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Best radiographic response

Incidence of treatment-related grade 3 adverse events

Secondary study objectives

Overall survival

Progression-free survival

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (encorafenib, cetuximab, nivolumab)Experimental Treatment3 Interventions

Patients receive encorafenib PO QD on days 1-28, cetuximab IV over 1 hour on days 1 and 15, and nivolumab IV over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cetuximab

2011

Completed Phase 3

~2480

Encorafenib

2022

Completed Phase 3

~970