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Checkpoint Inhibitor

Pembrolizumab + Chemotherapy for Esophageal Cancer

Phase 2
Waitlist Available
Led By Manish Shah, MD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinical tumor stage should be T2 Npositive M0 or T3--T4, Nany, M0
Patients must have histologically or cytologically confirmed esophageal or GEJ adenocarcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until death from any cause or for a maximum of 5 years
Awards & highlights

Study Summary

This trial is testing a new cancer treatment that combines immunotherapy, chemotherapy, and radiation. The goal is to see if it's more effective than just using chemotherapy and radiation.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Pembrolizumab can cause immune system reactions that may affect organs like lungs or intestines; Taxol and Carboplatin might lead to low blood cell counts increasing infection risk, fatigue, hair loss, nerve damage causing numbness or tingling sensations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is at a specific stage but hasn't spread to distant parts.
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My cancer is confirmed to be esophageal or GEJ adenocarcinoma.
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I am willing to give a tissue sample of my tumor during an endoscopy.
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I am eligible for surgery to remove my cancer.
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My kidney function, measured by creatinine or GFR, is within the normal range.
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I am 18 years old or older.
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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until death from any cause or for a maximum of 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and until death from any cause or for a maximum of 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Major Pathological Response
Secondary outcome measures
Number of Participants That Remained Progression Free as of 1 Year
Overall Survival Rates
R0 Resection Rate.
Other outcome measures
Association of Anti-PD1 Therapy With Increased Intra-tumoral Immune Cell Infiltration.
Improved 1 Year Survival
Induction of PD-L1 Expression or Induction of an Inflammatory Signature in Tumors.
+2 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Taxol
2001
Completed Phase 3
~3310
Carboplatin
2014
Completed Phase 3
~6670
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,059 Previous Clinical Trials
1,316,101 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,907 Previous Clinical Trials
5,066,054 Total Patients Enrolled
Manish Shah, MDPrincipal InvestigatorWeill Medical College of Cornell University
6 Previous Clinical Trials
368 Total Patients Enrolled

Media Library

Pembrolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02998268 — Phase 2
Esophageal Cancer Research Study Groups: Cohort 1, Cohort 2
Esophageal Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT02998268 — Phase 2
Pembrolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02998268 — Phase 2
~5 spots leftby Jun 2025
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