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Monoclonal Antibodies

Triple Therapy for Advanced Solid Cancers

Phase 1

Waitlist Available

Led By David S Hong

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

Cancers with positive BRAF V600 mutation detected by a Clinical Laboratory Improvement Act (CLIA)-certified laboratory

Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

Must not have

Presence of symptomatic pleural and/or pericardial effusion not appropriately treated

Prolonged corrected QT (QTc) interval (>= 450 msec) as calculated by Bazett's formula, or patients with a history of congenital long QT syndrome or uncorrectable electrolyte abnormalities

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the side effects and best dose of vemurafenib when given with cetuximab and irinotecan hydrochloride to treat patients with solid tumors. Vemurafenib and irinotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cetuximab may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Who is the study for?

This trial is for patients with solid tumors that have spread or can't be surgically removed, and who have a specific BRAF V600 mutation. They should not have received recent tumor treatment, must be able to swallow pills, and agree to use contraception. Those with severe medical conditions or certain heart issues are excluded.

What is being tested?

The trial tests the combination of vemurafenib, cetuximab, and irinotecan hydrochloride on patients with advanced solid tumors. It aims to find the safest dose while assessing how these drugs affect tumor growth by blocking enzymes and boosting the immune system's response.

What are the potential side effects?

Possible side effects include reactions related to immune system activation such as skin rash or infusion-related symptoms, liver enzyme changes indicating potential liver damage, fatigue from anemia or low blood counts due to bone marrow suppression, digestive disturbances like diarrhea or constipation.

Eligibility Criteria

Inclusion Criteria

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

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My cancer has a BRAF V600 mutation.

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I can take care of myself and am up and about more than half of my waking hours.

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My cancer has spread and cannot be removed with surgery.

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My tumor is K-RAS wild-type.

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My liver function tests are within the required limits.

Exclusion Criteria

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

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I have fluid buildup in my chest or heart area that hasn't been treated.

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My heart's electrical activity or electrolyte levels are abnormal.

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I cannot swallow pills.

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I am currently undergoing chemotherapy.

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I have not fully recovered from surgery within the last 4 weeks.

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I am not taking strong medication that affects liver enzyme CYP3A4.

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My cancer is BRAF wild-type.

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My cancer has a K-RAS mutation detected by an FDA-approved test.

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I do not have any severe illnesses like ongoing infections or bowel blockages.

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I have severe heart failure or unstable chest pain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Maximum tolerated dose of vemurafenib defined as the highest dose studied in which the incidence of dose limiting toxicity was less than 33% as graded by the National Cancer Institute Common Toxicity Criteria version 4.0

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 (vemurafenib, cetuximab, irinotecan hydrochloride)Experimental Treatment5 Interventions

Patients receive vemurafenib PO BID on days 1-14, cetuximab IV over 90 minutes, and irinotecan hydrochloride IV over 90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vemurafenib

2015

Completed Phase 3

~3550

Cetuximab

2011

Completed Phase 3

~2480