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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 1 year
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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease free survival rate
Secondary outcome measures
1 year overall survival rates.
Median survival rates.
Pathologic complete response rate
+2 moreOther 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.
+1 moreSide effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
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%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
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
1,054 Previous Clinical Trials
1,316,489 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,532 Total Patients Enrolled
Manish Shah, MDPrincipal InvestigatorWeill Medical College of Cornell University
6 Previous Clinical Trials
368 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received a live vaccine within the last 30 days, except for the flu shot.I am using two birth control methods or am not having sex to join this study.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I have or had lung inflammation not caused by an infection.I have been diagnosed with HIV.My blood clotting time is normal or managed if I'm on blood thinners.My cancer is at a specific stage but hasn't spread to distant parts.I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.I have another cancer, but it's either skin cancer treated with the intent to cure, or in situ cervical cancer.You are allergic to pembrolizumab or any of its ingredients.I am currently being treated for an infection with medication.My cancer has spread to other parts of my body.My organ functions are within normal ranges as per recent tests.I agree to use birth control during and for 4 months after the study.My cancer is confirmed to be esophageal or GEJ adenocarcinoma.I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.I am willing to give a tissue sample of my tumor during an endoscopy.I have not had active tuberculosis in the last 10 years.I am eligible for surgery to remove my cancer.My blood clotting time is normal or near normal, even if I'm on blood thinners.My kidney function, measured by creatinine or GFR, is within the normal range.I had cancer treated to cure it less than 3 years ago, but it wasn't prostate, skin, or cervical cancer.I have received treatment like chemotherapy or radiation for esophageal cancer.I am 18 years old or older.I am fully active or restricted in physically strenuous activity but can do light work.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1
- Group 2: Cohort 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what degree do people risk harm from using Pembrolizumab?
"Given its status as a Phase 2 trial, there is some evidence to suggest the safety of Pembrolizumab. Nevertheless, it earned an assessment score of two due to lack of clinical data supporting efficacy."
Answered by AI
Are there any precedents for Pembrolizumab's use in clinical trials?
"At present, 1988 Pembrolizumab trials are ongoing. Of those, 413 have reached the Phase 3 stage of development. Shanghai is unsurprisingly home to many of these studies; however, there are an extraordinary 91452 sites worldwide hosting medical research into this treatment."
Answered by AI
Are any individuals below the age of twenty permitted to participate in this research?
"The eligibility requirement for this trial is that participants must be aged 18 years or over and no older than 99."
Answered by AI
What is the aggregate amount of individuals participating in this experiment?
"This clinical trial is currently not searching for participants. The research first appeared on the 3rd of July 2017 and was last amended on June 6th 2022. Those seeking other studies have 961 trials actively recruiting cancer patients with esophagus issues, and 1988 trails where pembrolizumab is being administered."
Answered by AI
Is enrollment for this experiment still available?
"Unfortunately, this research has concluded its recruitment phase. Initial postings were made on March 7th 2017 and the last edits occurred on June 6th 2022. However, there are currently 961 trials investigating cancer of esophagus and 1988 studies related to Pembrolizumab that are actively enrolling participants."
Answered by AI
Could I potentially sign up for this research project?
"Eligibility criteria for this experiment dictates that candidates should have esophageal cancer and be between 18 to 99 years old. Approximately 39 participants are being sought after."
Answered by AI
What therapeutic uses is Pembrolizumab commonly employed for?
"Pembrolizumab can be used to combat malignant tumours, microsatellite instability high, and cases of unresectable melanoma."
Answered by AI
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