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Pembrolizumab for Esophageal Cancer

Phase 3

Waitlist Available

Research Sponsored by Merck Sharp & Dohme LLC

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 up to approximately 34 months (through primary analysis cut-off date of 02-jul-2020)

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 34 months (through primary analysis cut-off date of 02-jul-2020)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 34 months (through primary analysis cut-off date of 02-jul-2020)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 34 months (through primary analysis cut-off date of 02-jul-2020) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

OS in All Participants

OS in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10)

OS in Participants With ESCC

+4 more

Secondary outcome measures

Change From Baseline To Week 18 in the EORTC QLQ-C30 GHS/QoL Combined Score in Participants Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10)

Change From Baseline To Week 18 in the EORTC QLQ-C30 GHS/QoL Combined Score in Participants With ESCC

Change From Baseline To Week 18 in the EORTC QLQ-C30 GHS/QoL Combined Score in Participants With ESCC Whose Tumors Are PD-L1 Biomarker-Positive (CPS ≥10)

+15 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183

21%

Fatigue

13%

Nausea

11%

Back pain

Shortness of Breath

Anemia

Abdominal pain

Diarrhea

Pneumonia

Kidney Injury and/or Infection

Dyspnea

Weight Loss

Malnutrition, Hypercalcemia and Weakness

Pneumothorax

Intractable pain, back pain, hip pain

Activated partial thromboplastin time prolonged

Pleural effusion

Atrial fibrillation with rapid ventricular response

Thrombocytopenia

Respiratory failure

Skin rash

colitis

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Pembrolizumab + SOCExperimental Treatment3 Interventions

Participants receive pembrolizumab 200 mg intravenously (IV) every 3 weeks (Q3W) plus standard of care (SOC) chemotherapy with cisplatin 80 mg/m^2 IV Q3W and 5-FU 800 mg/m^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments will be administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.

Group II: Placebo + SOCPlacebo Group3 Interventions

Participants receive placebo to pembrolizumab (saline) IV Q3W plus SOC chemotherapy with cisplatin 80 mg/m^2 IV Q3W and 5-FU 800 mg/m^2/day continuous IV infusion on Days 1 to 5 (120 hours) Q3W. All treatments will be administered on an outpatient basis beginning on Day 1 of each 3-week dosing cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

Cisplatin

2013

Completed Phase 3

~1940

5-FU

2014

Completed Phase 3

~3420

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor

3,886 Previous Clinical Trials

5,053,804 Total Patients Enrolled

Merck Sharp & Dohme Corp.Lead Sponsor

2,286 Previous Clinical Trials

4,581,079 Total Patients Enrolled

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,777 Previous Clinical Trials

8,062,737 Total Patients Enrolled

Frequently Asked Questions

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

At how many different sites is this medical trial being conducted?

"In addition to The University of Chicago Medical Center (Site 0001) in Chicago, Illinois and University of Kansas (Site 0029) in Westwood, Kansas, this clinical trial is also enrolling patients at 20 other locations including University of Maryland Medical Center ( Site 0013) in Baltimore, Maryland."

Answered by AI

What is the latest update on Pembrolizumab's progress towards FDA approval?

"Pembrolizumab has been studied in Phase 3 clinical trials, meaning that while there is data supporting its efficacy, multiple rounds of testing have also shown that it is safe."

Answered by AI

For what purpose is Pembrolizumab most often prescribed?

"Pembrolizumab is not just limited to the treatment of malignant neoplasms; it can also help patients manage unresectable melanoma, microsatellite instability high, and rectal carcinoma."

Answered by AI

How many individuals can take part in this research project?

"This particular study is no longer looking for new patients, as noted by the last edit date of January 17th, 2022. However, there are 288 other trials involving cancer of the esophagus that are still enrolling patients and 1852 studies involving Pembrolizumab currently have open recruitment."

Answered by AI

Are patients still being recruited for this research?

"This study is no longer recruiting patients. The clinical trial was first posted on July 25th, 2017 and the last edit was made on January 17th, 2022. However, there are currently 288 trials actively looking for patients with cancer of the esophagus and 1852 studies for Pembrolizumab that are actively searching for participants."

Answered by AI

What are the main goals of this clinical research project?

"The primary outcome of this study is to OS (overall survival) in participants with ESCC (esophageal squamous cell carcinoma). Secondary outcomes include ORR per RECIST 1.1 as assessed by investigator in participants with ESCC whose tumors are PD-L1 biomarker-positive (CPS ≥10), which is defined as ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1,"

Answered by AI

What is the historical context of Pembrolizumab research?

"Pembrolizumab is currently being trialed in 1852 active studies, with 435 of those trials in the later stages. The majority of these clinical trials are based out of Shanghai; however, there are 83547 total locations running some form of Pembrolizumab trial."

Answered by AI