Pembrolizumab + Chemotherapy for Esophageal Cancer

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen ByManish Shah, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Weill Medical College of Cornell University

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial is testing if adding pembrolizumab to standard treatments can help patients with advanced esophageal cancer. Pembrolizumab boosts the immune system to better fight cancer. The goal is to see if this combination improves patient outcomes. Pembrolizumab has been used in various cancers, including melanoma, lung cancer, and head and neck cancer, showing durable responses and significant advancements in treatment options.

Eligibility Criteria

This trial is for adults over 18 with locally advanced esophageal adenocarcinoma, who haven't had prior cancer treatments for their current diagnosis. They must have certain blood cell counts and organ function levels, be willing to provide tissue samples, and agree to use birth control. Exclusions include active infections, other recent cancers except some skin or prostate cancers, autoimmune diseases needing treatment in the last 2 years, known HIV or hepatitis B/C.

Inclusion Criteria

My cancer is at a specific stage but hasn't spread to distant parts.

My cancer is confirmed to be esophageal or GEJ adenocarcinoma.

I am willing to give a tissue sample of my tumor during an endoscopy.

I am eligible for surgery to remove my cancer.

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

I am 18 years old or older.

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

I have been diagnosed with HIV.

I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.

I have or had lung inflammation not caused by an infection.

I am currently being treated for an infection with medication.

My cancer has spread to other parts of my body.

I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.

I have received treatment like chemotherapy or radiation for esophageal cancer.

Participant Groups

The study tests Pembrolizumab combined with chemotherapy (Taxol and Carboplatin) and chemoradiation on patients with esophageal adenocarcinoma. It's a phase II trial aiming to see how safe this combination is and how well it works by looking at disease-free survival after one year.

2Treatment groups

Experimental Treatment

Group I: Cohort 2Experimental Treatment3 Interventions

Subjects in Cohort 2 receive pembrolizumab along with induction chemotherapy with taxol/ carboplatin followed by weekly chemoradiation (taxol/ carboplatin) with pembrolizumab. Following surgery, pembrolizumab is administered every 3 weeks for 1 year. Pembrolizumab dosing is 200 mg administered as a 30 minute IV infusion.

Group II: Cohort 1Experimental Treatment3 Interventions

Subjects in Cohort 1 receive conventional induction chemotherapy with taxol/ carboplatin followed by weekly chemoradiation (taxol/ carboplatin) with pembrolizumab. Following surgery, pembrolizumab is administered every 3 weeks for 1 year. Pembrolizumab dosing is 200 mg administered as a 30 minute IV infusion.

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

🇺🇸 Approved in United States as KEYTRUDA for: