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PD-1 Inhibitor

Pembrolizumab for Esophageal Cancer

Phase 2
Waitlist Available
Led By Peter C. Enzinger, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up disease was evaluated each cycle on treatment and in long-term follow-up every 12 weeks for up to 5 years. maximum follow-up in this study cohort was 38.7 months.
Awards & highlights

Study Summary

This trial is studying how well pembrolizumab works in treating patients with advanced esophageal cancer. Pembrolizumab is a type of immunotherapy that works by helping the body's immune system kill cancer cells.

Eligible Conditions
  • Esophageal Cancer
  • Squamous Cell Carcinoma
  • Esophageal Adenocarcinoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~disease was evaluated each cycle on treatment and in long-term follow-up every 12 weeks for up to 5 years. maximum follow-up in this study cohort was 38.7 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and disease was evaluated each cycle on treatment and in long-term follow-up every 12 weeks for up to 5 years. maximum follow-up in this study cohort was 38.7 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
Overall Response Rate (ORR)
Secondary outcome measures
Median Overall Survival (OS)
Median Progression-free Survival (PFS)
Number of Patients Experiencing Grade 3-4 Treatment-Related Toxicity

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%
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

1Treatment groups
Experimental Treatment
Group I: PembrolizumabExperimental Treatment1 Intervention
Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,899 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,887 Previous Clinical Trials
5,054,645 Total Patients Enrolled
Peter C. Enzinger, MDPrincipal InvestigatorDana-Farber Cancer Institute
4 Previous Clinical Trials
231 Total Patients Enrolled

Media Library

Pembrolizumab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02971956 — Phase 2
Esophageal Cancer Research Study Groups: Pembrolizumab
Esophageal Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT02971956 — Phase 2
Pembrolizumab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02971956 — Phase 2

Frequently Asked Questions

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

To what ailments does Pembrolizumab offer therapeutic benefit?

"Pembrolizumab is traditionally used to treat malignant neoplasms, but can also be beneficial for individuals facing unresectable melanoma, microsatellite instability high or progression after chemotherapy."

Answered by AI

What other research has been conducted using Pembrolizumab?

"Currently, there are 961 active studies analyzing Pembrolizumab and 122 of these trials have reached Phase 3. Most research sites for this particular drug are found in Houston, Texas but it is also available at 35731 distinct medical facilities."

Answered by AI

What objectives is this trial designed to achieve?

"The primary purpose of this clinical trial is to ascertain the Major Response Rate (CR + PR) Of Patients With Refractory Esophageal Adenocarcinoma To Pembrolizumab. Furthermore, secondary outcomes include Median Overall Survival (OS), Evaluate The Safety And Tolerability Of Pembrolizumab 200 Mg, Administered Every Three Weeks, In Advanced Esophageal cancer., and Median Progression-free Survival (PFS). Disease was evaluated each cycle on treatment; Treatment continued until disease progression or unacceptable toxicity. Treatment duration was a median of 2.1 months with a maximum of"

Answered by AI

Has the Food and Drug Administration sanctioned Pembrolizumab?

"Our experts at Power assigned a score of 2 to Pembrolizumab due to the limited clinical data that has been collected, as it is only in Phase 2 trials and there are no results yet showing efficacy."

Answered by AI

How many participants are chosen for this research project?

"At this time, there are no available openings for the previously mentioned trial. This medical study was initially posted on January 18th 2017 and most recently updated on April 7th 2022. If you're still interested in participating in a clinical trial related to esophageal squamous cell carcinoma, 503 studies have open positions while 961 trials are actively recruiting patients with Pembrolizumab treatment plans."

Answered by AI

Is this research project recruiting participants currently?

"This trial is currently dormant; the last amendment occurred on April 7th, 2022. For those searching for other trials, 503 studies with esophageal squamous cell carcinoma and 961 Pembrolizumab-focused clinical programs are actively recruiting patients."

Answered by AI
~6 spots leftby Apr 2025