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Chemotherapy

Chemoradiation + Pembrolizumab/Lenvatinib for Esophageal Cancer

Phase 2

Waitlist Available

Led By Joseph Chao

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

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

Must have

Radiation defined as external beam radiotherapy with 50.4 Gy

Eastern Cooperative Oncology Group (ECOG) =< 1

Must not have

Known history of active tuberculosis

Immune checkpoint inhibitor(s) (e.g. anti-PD-1, anti-CTLA4)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying the effect of giving chemoradiation and pembrolizumab followed by pembrolizumab and lenvatinib before surgery to treat patients with esophageal or esophageal/gastroesophageal junction cancer that has not spread to other places in the body.

Who is the study for?

Adults with non-metastatic esophageal or gastroesophageal junction cancer suitable for chemoradiation and surgery. Participants must have certain blood cell levels, organ function within specific limits, and agree to use birth control. Excluded are those with recent other treatments, immune conditions, severe allergies to similar drugs, active infections like HIV or hepatitis B/C, pregnant/breastfeeding women, and anyone unlikely to follow the study plan.

What is being tested?

The trial is testing if a combination of chemoradiation (carboplatin/paclitaxel) and immunotherapy drug pembrolizumab followed by pembrolizumab plus anti-cancer drug lenvatinib before surgery can effectively treat patients. The goal is to see if this regimen kills more tumor cells compared to current standard treatments.

What are the potential side effects?

Possible side effects include reactions from the immune system attacking normal organs due to pembrolizumab; high blood pressure, fatigue from lenvatinib; hair loss, nerve damage from chemotherapy; skin irritation from radiation therapy. Each treatment carries its own risk profile which will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

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

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I have received a specific dose of radiation therapy.

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

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My cancer is in the esophagus or where the esophagus meets the stomach and has not spread.

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I am 18 years old or older.

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My cancer is stage I-IVA and is one of the specified types.

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I am receiving carboplatin and paclitaxel on a weekly basis.

Exclusion Criteria

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

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I have an active case of tuberculosis.

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I have not been treated with immune checkpoint inhibitors.

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I have a history of HIV, hepatitis B, or hepatitis C.

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I am taking or have taken a drug like lenvatinib.

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I haven't had recent cancer drug treatments or major surgery.

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I do not have active diverticulitis, abdominal infections, blockages, or widespread cancer in my abdomen.

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I am not pregnant or breastfeeding.

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I am on long-term steroids or medications that suppress my immune system.

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I have not received a live-virus vaccine in the last 30 days.

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I do not have untreated brain cancer spread.

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I have had or currently have lung inflammation treated with steroids.

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I am taking blood thinners that are coumarin-based.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

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

Clinical complete response (CR)

Pathological complete response (CR)

Secondary study objectives

Disease

Immune-mediated tumor cytotoxicity

Incidence of adverse events

+1 more

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 (chemoradiation, pembrolizumab, lenvatinib)Experimental Treatment7 Interventions

CHEMORADIATION PHASE: Patients receive carboplatin IV and paclitaxel IV QW for up to 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo EBRT over 6 weeks and receive pembrolizumab IV over 30 minutes on day 1 of radiation therapy in the absence of disease progression or unacceptable toxicity. WINDOW PERIOD: Patients receive pembrolizumab IV over 30 minutes on day 1 of week 3 and lenvatinib mesylate PO QD at weeks 3-6 in the absence of disease progression or unacceptable toxicity. SURGERY/SURVEILLANCE: Patients without complete response undergo standard of care surgical resection. Patients with complete response/pursue non-operative management undergo surveillance via periodic endoscopic biopsy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

2011

Completed Phase 4

~5450

Resection

2020

Completed Phase 2

~1440