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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Is not expected to require tumor resection during the course of the study
Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 3 days of the first dose of study treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to ~72 months
Awards & highlights
Study Summary
This trial is testing a new cancer treatment that may be more effective and have fewer side effects than the current standard of care.
Who is the study for?
This trial is for adults with esophageal cancer who can't have surgery, are not pregnant or breastfeeding, and agree to use effective contraception. They should be in good physical condition (ECOG 0-1), have proper organ function, and no recent heart attacks or active infections like HIV or hepatitis.Check my eligibility
What is being tested?
The study tests if adding pembrolizumab to standard chemoradiotherapy improves survival compared to a placebo plus the same therapy. It focuses on patients whose tumors express certain levels of PD-L1 protein.See study design
What are the potential side effects?
Pembrolizumab may cause immune system-related side effects such as inflammation in various organs, skin reactions, hormone gland problems (like thyroid issues), and infusion-related reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not expected to need surgery to remove a tumor during the study.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My cancer is confirmed and located in the esophagus or gastroesophageal junction, without distant spread, or it's in the upper esophagus with only neck lymph node spread.
Select...
I am not pregnant or breastfeeding.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to ~72 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to ~72 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Event-free Survival (EFS)
Overall Survival (OS)
Secondary outcome measures
Number of participants discontinuing study treatment due to an adverse event (AE)
Number of participants with an adverse event (AE)
Side effects data
From 2022 Phase 3 trial • 1274 Patients • NCT0222089412%
Weight decreased
9%
Alanine aminotransferase increased
9%
Aspartate aminotransferase increased
9%
Decreased appetite
9%
Arthralgia
9%
Constipation
9%
Haemoptysis
9%
Diarrhoea
9%
Hypothyroidism
9%
Nasopharyngitis
9%
Bronchitis
6%
Cough
6%
Asthenia
6%
Pruritus
6%
Anaemia
6%
Pneumonia
6%
Headache
6%
Blood alkaline phosphatase increased
3%
Rash
3%
Leukopenia
3%
Malaise
3%
Hyperglycaemia
3%
Pneumonia bacterial
3%
White blood cell count decreased
3%
Back pain
3%
Myalgia
3%
Hypertension
3%
Pyrexia
3%
Hyperthyroidism
3%
Upper respiratory tract infection
3%
Nausea
3%
Dyspnoea
3%
Chest pain
3%
Subdural haemorrhage
3%
Lymph gland infection
3%
Tumour associated fever
3%
Haematemesis
3%
Upper gastrointestinal haemorrhage
3%
Oedema peripheral
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab Second Course
Pembrolizumab
Chemotherapy (SOC Treatment)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Pembrolizumab+FP or FOLFOX Therapy+RadiotherapyExperimental Treatment7 Interventions
Participants receive pembrolizumab 200 mg on Day 1 of each 3-week cycle for 8 cycles followed by pembrolizumab 400 mg on Day 1 of each 6-week cycle for 5 cycles PLUS either:
FP therapy: cisplatin 75 mg/m^2 on Day 1 of Weeks 1, 5, 8 and 11 PLUS 5-fluorouracil (5-FU)] 1000 mg/m^2 per day on Days 1-4 of Weeks 1, 5, 8 and 11 OR 800 mg/m^2/day on each of Days 1-5 at Weeks 1, 5, 8, and 11 PLUS radiotherapy (either 50 Gray [Gy] in 25 fractions OR 60 Gy in 30 fractions) on Days 1-5 of each 3-week cycle OR
FOLFOX therapy: oxaliplatin 85 mg/m^2 AND either leucovorin 400 mg/m^2 OR levoleucovorin 200 mg/m^2 on Day 1 of Weeks 1, 3, 5, 7, 9 and 11 PLUS either 5-FU 400 mg/m^2 on Day 1 of Weeks 1, 3, 5, 7, 9 and 11 OR 5-FU 800 mg/m^2 per day on Days 1 and 2 of Weeks 1, 3, 5, 7, 9 and 11 PLUS radiotherapy (50 Gy in 25 fractions) on Days 1-5 of each 3-week cycle.
All treatments except radiotherapy are given by intravenous (IV) infusion. Total treatment duration is approximately 1 year.
Group II: Placebo+FP or FOLFOX Therapy+RadiotherapyPlacebo Group7 Interventions
Participants receive placebo on Day 1 of each 3-week cycle for 8 cycles followed by placebo on Day 1 of each 6-week cycle for 5 cycles PLUS either:
FP therapy: cisplatin 75 mg/m^2 on Day 1 of Weeks 1, 5, 8 and 11 PLUS 5-FU 1000 mg/m^2 per day on Days 1-4 of Weeks 1, 5, 8 and 11 OR 800 mg/m^2/day on each of Days 1-5 at Weeks 1, 5, 8, and 11 PLUS radiotherapy (either 50 Gy in 25 fractions OR 60 Gy in 30 fractions) on Days 1-5 of each 3-week cycle OR
FOLFOX therapy: oxaliplatin 85 mg/m^2 AND either leucovorin 400 mg/m^2 OR levoleucovorin 200 mg/m^2 on Day 1 of Weeks 1, 3, 5, 7, 9 and 11 PLUS either 5-FU 400 mg/m^2 on Day 1 of Weeks 1, 3, 5, 7, 9 and 11 OR 5-FU 800 mg/m^2 per day on Days 1 and 2 of Weeks 1, 3, 5, 7, 9 and 11 PLUS radiotherapy (50 Gy in 25 fractions) on Days 1-5 of each 3-week cycle.
All treatments except radiotherapy are given by IV infusion. Total treatment duration is approximately 1 year.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pembrolizumab
2017
Completed Phase 3
~5750
5-FU
2014
Completed Phase 3
~3420
cisplatin
1997
Completed Phase 3
~3290
oxaliplatin
2002
Completed Phase 3
~6370
radiotherapy
2007
Completed Phase 4
~3210
leucovorin
2005
Completed Phase 3
~1200
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,128 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,886 Previous Clinical Trials
5,053,853 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,062,786 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had treatment for esophageal cancer before.I am not expected to need surgery to remove a tumor during the study.I haven't had major surgery in the last 28 days and don't expect to need any during the study.My doctor thinks I am a good candidate for combined chemotherapy and radiation.I have been treated for an autoimmune disease in the last 2 years.I am a male willing to use effective birth control or am unable to father children, and will not donate sperm during and for 90 days after the study.I am fully active or restricted in physically strenuous activity but can do light work.I have not received a live vaccine within the last 30 days.I have another cancer besides skin or localized prostate cancer that needed treatment in the last 3 years.I have had pneumonitis treated with steroids or have it now.I have received chemotherapy or radiotherapy for esophageal cancer.I have been treated with specific immune system targeting drugs before.I am using or willing to use effective birth control or practice abstinence during and after the study.A cancer specialist has determined I cannot be cured with surgery.My cancer is confirmed and located in the esophagus or gastroesophageal junction, without distant spread, or it's in the upper esophagus with only neck lymph node spread.My organs are functioning well.I have received an organ or tissue transplant from another person.I am highly allergic to pembrolizumab or any of the study drugs.I have a history of Hepatitis B or active Hepatitis C.I have an active tuberculosis infection.I have an immune system disorder or have been on steroids or other immune-weakening medicines recently.I had a heart attack in the last 6 months.I am not pregnant or breastfeeding.My tumor has spread to nearby organs or major blood vessels.I am currently being treated for an infection with medication.I have recovered from side effects of previous treatments to my normal or mild condition.I have symptoms of heart failure.I have lost more than 20% of my weight in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab+FP or FOLFOX Therapy+Radiotherapy
- Group 2: Placebo+FP or FOLFOX Therapy+Radiotherapy
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Is it still possible to sign up for this research project?
"Yes, this clinical trial is still recruiting patients. The dates on clinicaltrials.gov show that the trial was originally posted on February 28th, 2020, and was last updated on October 21st, 2020."
Answered by AI
How many places in North America are running this research project?
"Currently, this clinical trial is enrolling patients from 22 different sites. These locations include Detroit, Long Beach, New Brunswick and other cities. To reduce the amount of travel required, you should select the location closest to you."
Answered by AI
What is the pembrolizumab FDA status?
"Pembrolizumab has received a score of 3 by our analysts at Power. Phase 3 trials have some data to support efficacy and multiple rounds of data supporting safety."
Answered by AI
Are there any other pembrolizumab trials that have been completed or are ongoing?
"Pembrolizumab is being studied in 2069 active clinical trials, 516 of which are in Phase 3. There are several trials running out of Guangzhou, Guangdong; however, there are 89534 total locations for trials of pembrolizumab."
Answered by AI
How many test subjects are being enrolled in this clinical trial?
"According to the sponsor's website, 600 participants are needed to carry out this clinical trial. The trial will be conducted by Merck Sharp & Dohme Corp. at various medical centres, two of which are Rutgers Cancer Institute of New jersey ( Site 0695) located in New Brunswick, New Jersey and Henry Ford Hospital ( Site 0685) in Detroit, Michigan."
Answered by AI
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