Chemoradiation + Pembrolizumab/Lenvatinib for Esophageal Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Joseph Chao

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This phase II trial studies the effect of chemoradiation and pembrolizumab followed by pembrolizumab and lenvatinib before surgery in treating patients with esophageal or esophageal/gastroesophageal junction cancer that has not spread to other places in the body (non-metastatic). Pembrolizumab is an immunotherapy drug that works by harnessing the immune system to attack cancer. Lenvatinib is an anti-cancer drug that works by stopping or slowing down the growth of cancer cells. Chemotherapy drugs, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving chemoradiation and pembrolizumab followed by pembrolizumab and lenvatinib before surgery may kill more tumor cells.

Eligibility Criteria

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.

Inclusion Criteria

I have received a specific dose of radiation therapy.

Exceptions may be granted only with study principal investigator (PI) approval if archival tissue is unavailable

Documented informed consent of the participant and/or legally authorized representative

Exclusion Criteria

I have not had radiotherapy in the last 21 days.

I have an active case of tuberculosis.

I have not been treated with immune checkpoint inhibitors.

Participant Groups

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.

Group I: Treatment (chemoradiation, pembrolizumab, lenvatinib) Experimental Treatment 7 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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

City of Hope Medical Center Duarte, CA

Who Is Running the Clinical Trial?

City of Hope Medical Center Lead Sponsor

National Cancer Institute (NCI) Collaborator

References