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Anti-tumor antibiotic

pembrolizumab for Esophageal Cancer

Phase 2
Waitlist Available
Led By Yelena Janjigian, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have disease that can be evaluated radiographically. This may be measurable disease or non-measurable disease per RECIST 1.1.
Additional available archival tumor tissue in the form of 15-20 unstained slides should be submitted to MSKCC for future correlative analysis, but will not be required prior registration. Note: if tissue is depleted, patient will still be eligible after discussion with the MSK PI.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial is testing a new cancer treatment combination to see what effects it has on patients with esophagogastric cancer.

Eligible Conditions
  • Esophageal Cancer
  • Stomach Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Your disease can be assessed using medical imaging tests. This includes both visible and non-visible signs of the disease according to a specific standard called RECIST 1.1.
Select...
You need to provide 15-20 unstained slides of your tumor tissue for future research purposes. However, this is not mandatory for your participation in the study. If you don't have enough tissue, you can still participate in the study after discussing with the study leader.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants With Progression Free Survival

Side effects data

From 2022 Phase 3 trial • 1274 Patients • NCT02220894
12%
Weight decreased
9%
Diarrhoea
9%
Arthralgia
9%
Alanine aminotransferase increased
9%
Aspartate aminotransferase increased
9%
Haemoptysis
9%
Nasopharyngitis
9%
Bronchitis
9%
Decreased appetite
9%
Hypothyroidism
9%
Constipation
6%
Pruritus
6%
Pneumonia
6%
Cough
6%
Anaemia
6%
Blood alkaline phosphatase increased
6%
Asthenia
6%
Headache
3%
Nausea
3%
Haematemesis
3%
Rash
3%
Pyrexia
3%
Chest pain
3%
Leukopenia
3%
Upper gastrointestinal haemorrhage
3%
Subdural haemorrhage
3%
Lymph gland infection
3%
White blood cell count decreased
3%
Pneumonia bacterial
3%
Tumour associated fever
3%
Dyspnoea
3%
Hyperthyroidism
3%
Myalgia
3%
Hyperglycaemia
3%
Hypertension
3%
Upper respiratory tract infection
3%
Back pain
3%
Malaise
3%
Oedema peripheral
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab Second Course
Pembrolizumab
Chemotherapy (SOC Treatment)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Pembrolizumab, trastuzumab,capecitabine/cisplatinExperimental Treatment6 Interventions
Pembrolizumab 200 mg IV every 3 weeks, trastuzumab (8 mg/kg loading dose; 6 mg/kg maintenance) IV every 3 weeks with cisplatin IV every 3 weeks with oral capecitabine 2 weeks on/1 week off. Each cycle consists of 21 days. Treatment will be administered on an outpatient basis. In Cycle 1, patients will initiate therapy with trastuzumab 8 mg/kg IV with pembrolizumab 200 mg IV. CT/MRI scan will be performed after the initial 3 weeks (1 cycle) to determine response to pembrolizumab and trastuzumab combination. With subsequent cycles, all patients will begin systemic chemotherapy with the capecitabine/cisplatin regimen in addition to pembrolizumab 200 mg IV with trastuzumab 6 mg/kg maintenance. Patients will receive cisplatin 80 mg/m2 IV on Day 1, and capecitabine 850mg/m2 twice a day on Days 1 through 14, every 3 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxaliplatin
FDA approved
Fluorouracil
FDA approved
Pembrolizumab
FDA approved
Trastuzumab
FDA approved
Capecitabine
FDA approved
Cisplatin
FDA approved

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,928 Previous Clinical Trials
591,771 Total Patients Enrolled
Yelena Janjigian, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
11 Previous Clinical Trials
1,035 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any serious risks associated with pembrolizumab treatment?

"The safety of pembrolizumab has been rated as a 2 since it is currently running Phase 2 trials with limited evidence in regards to efficacy and moderate data regarding safety."

Answered by AI

Is there any precedent for utilizing pembrolizumab in medical research?

"Pembrolizumab was first studied at the City of Hope Comprehensive Cancer Center in 1997 and has since been a subject of 2543 trials. Currently, there are 2251 studies that have open recruitment; Middletown, New jersey serves as one major hub for these clinical investigations."

Answered by AI

How many healthcare facilities are actively participating in this trial?

"Patients may choose from 8 distinct clinical trial sites, including Memorial Sloan Kettering Monmouth in Middletown and other locations."

Answered by AI

What is the current number of participants in this research endeavor?

"Unfortunately, recruitment for this study has ended. It was initially announced on November 3rd 2016 and the last update was released September 19th 2022. For those seeking other trials involving esophageal neoplasms malignant there are 531 recruiting studies while 2251 clinical initiatives are actively searching for people to participate in research regarding pembrolizumab."

Answered by AI

Is there an ongoing recruitment process for this clinical experiment?

"Unfortunately, this clinical trial has closed its doors to new patients. Initially posted on the 3rd of November 2016 and last updated 19th September 2022, it is no longer actively looking for recruits. However, there are presently 531 trials recruiting participants with esophageal neoplasms malignant and 2,251 studies that require pembrolizumab volunteers."

Answered by AI

What medical indications is pembrolizumab designed to address?

"Pembrolizumab is regularly used for treating refractory, relapsed mediastinal large b-cell lymphoma. Additionally, it can be utilized to address many other conditions like advanced testicular cancer and inflammatory breast cancer (IBC). It has even been successful in controlling the proliferation of refractory fallopian tube carcinomas."

Answered by AI
~4 spots leftby Mar 2025