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PD-1 Inhibitor

Pembrolizumab for Squamous Cell Carcinoma

Phase 2

Waitlist Available

Research Sponsored by Ezra Cohen

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 3 years

Awards & highlights

Study Summary

This trial will test whether pembrolizumab can help people with squamous cell cancer of the head and neck who have had surgery to remove their cancer, and whose cancer has come back, to live disease-free for longer.

Eligible Conditions

Squamous Cell Carcinoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

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

Secondary outcome measures

Disease-Free Survival at 2 years

Overall Survival

Safety: Incidence of Adverse Events, Serious Adverse Events, and Treatment Delays

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

1Treatment groups

Experimental Treatment

Group I: PembrolizumabExperimental Treatment1 Intervention

Pembrolizumab 200 mg will be administered by IV infusion every 3 weeks up to 12 months or until disease progression

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Ezra CohenLead Sponsor

4 Previous Clinical Trials

66 Total Patients Enrolled

Merck Sharp & Dohme LLCIndustry Sponsor

3,878 Previous Clinical Trials

5,053,170 Total Patients Enrolled

Ezra Cohen, MD4.8134 ReviewsStudy Director - University of California, San Diego

13 Previous Clinical Trials

756 Total Patients Enrolled

5Patient Review

I had a really great experience getting my eyes checked. Donna was super helpful in picking out a new pair of frames.

Frequently Asked Questions

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

What is the recruitment capacity of this medical experiment?

"This clinical trial has concluded its recruitment process, with the initial posting date having been July 6th 2016 and the last update occurring on August 17th 2022. There are presently 2676 trials for oral squamous cell carcinoma that have open enrollment as well as 961 studies currently recruiting patients to receive Pembrolizumab treatments."

Answered by AI

Has the US Food and Drug Administration sanctioned Pembrolizumab?

"Our team at Power determined that pembrolizumab had a safety rating of 2, as the clinical trial is currently in its second phase. This means there is some evidence supporting the drug's security but none to demonstrate efficacy."

Answered by AI

What medical conditions has Pembrolizumab been demonstrated to ameliorate?

"Pembrolizumab has been approved as a medical intervention for malignant neoplasms and can also be used to treat irresectable melanoma, microsatellite instability high, and to mitigate the effects of chemotherapy."

Answered by AI

Are there any vacancies in this medical experiment that could accommodate new participants?

"Clinicaltrials.gov details that this medical trial has suspended its recruitment of patients. Originally posted on July 6th 2016, and last updated August 17th 2022, the study is no longer seeking participants; however 3637 other studies remain open for enrolment."

Answered by AI

Has Pembrolizumab been the focus of any past research initiatives?

"At present, 961 trials are being conducted to investigate the efficacy of Pembrozizumab. Of these studies, 122 are in their final phase. Most experimentation is centered in Houston, Texas yet there exist 35 731 test sites globally for this medication."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Efficacy Study of Pembrolizumab in Relapsed, Locally Recurrent Squamous Cell Cancer of the Head and Neck

Ezra Cohen 2016. "Efficacy Study of Pembrolizumab in Relapsed, Locally Recurrent Squamous Cell Cancer of the Head and Neck". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02769520.