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Pembrolizumab for Squamous Cell Carcinoma

Phase 3

Recruiting

Research Sponsored by Merck Sharp & Dohme Corp.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has histologically confirmed cutaneous squamous cell carcinoma (cSCC) as the primary site of malignancy (metastatic skin involvement from another type of primary cancer or from an unknown primary cancer is not permitted)

Has provided an archival or newly-obtained tumor tissue sample adequate for Programmed Cell Death Ligand 1 (PD-L1) testing as determined by central laboratory testing

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 63 months

Awards & highlights

Study Summary

This trial is testing whether pembrolizumab can help prevent recurrence of locally advanced cutaneous squamous cell carcinoma in high-risk patients who have undergone surgery and radiotherapy.

Who is the study for?

This trial is for adults with high-risk locally advanced cutaneous squamous cell carcinoma (LA cSCC) who've had surgery and radiotherapy. They must be disease-free post-treatment, not pregnant or breastfeeding, and have a life expectancy over 3 months. Excluded are those with active cancer other than LA cSCC, recent live vaccines, certain prior treatments including anti-PD-1/L1/L2 agents within 4 weeks, unresolved radiation toxicities, autoimmune diseases needing treatment in the past 2 years, or organ transplants.Check my eligibility

What is being tested?

The study tests pembrolizumab against a placebo to see if it can prevent cancer from coming back after surgery and radiation in patients with LA cSCC. Participants will randomly receive either pembrolizumab or a placebo without knowing which one they're getting (double-blind). The main goal is to compare how long each group stays cancer-free.See study design

What are the potential side effects?

Pembrolizumab may cause immune system-related side effects such as inflammation of organs like lungs (pneumonitis), skin reactions, hormone gland problems (like thyroid issues), infusion reactions during administration of the drug, fatigue, and possibly complications related to existing autoimmune diseases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is a type of skin cancer that started in the skin cells.

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I have provided a tissue sample for PD-L1 testing.

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My skin cancer is confirmed and has high-risk features.

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I have completed the required dose of radiation therapy after surgery.

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I finished my skin cancer radiation treatment 4 to 16 weeks ago.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 63 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 63 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 63 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

Recurrence-Free Survival (RFS) as Assessed by the Investigator and Confirmed by Biopsy

Secondary outcome measures

Change From Baseline in Physical Functioning Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 1-5 Score

Malignant Neoplasms

Overall Survival (OS)

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: PembrolizumabExperimental Treatment1 Intervention

Participants receive 400 mg pembrolizumab by intravenous (IV) infusion administered on Day 1 of each 42-day cycle (Q6W) for up to 9 cycles. Participants that complete 9 cycles of pembrolizumab and experience biopsy-proven-disease recurrence may be eligible to receive up to 18 additional cycles of pembrolizumab in an open-label design.

Group II: PlaceboPlacebo Group1 Intervention

Participants receive placebo by IV infusion administered on Day 1 of each 42-day cycle (Q6W) for up to 9 cycles. Participants treated with placebo who experience biopsy-proven-disease recurrence may be eligible to receive up to 18 cycles of pembrolizumab in an open-label design.

0 / 5Eligibility criteria met

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Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor

2,286 Previous Clinical Trials

4,581,398 Total Patients Enrolled

Merck Sharp & Dohme LLCLead Sponsor

3,886 Previous Clinical Trials

5,054,123 Total Patients Enrolled

Medical DirectorStudy DirectorMerck Sharp & Dohme LLC

2,777 Previous Clinical Trials

8,063,056 Total Patients Enrolled

Media Library

Pembrolizumab 400 mg Clinical Trial Eligibility Overview. Trial Name: NCT03833167 — Phase 3

Squamous Cell Carcinoma Research Study Groups: Pembrolizumab, Placebo

Squamous Cell Carcinoma Clinical Trial 2023: Pembrolizumab 400 mg Highlights & Side Effects. Trial Name: NCT03833167 — Phase 3

Pembrolizumab 400 mg 2023 Treatment Timeline for Medical Study. Trial Name: NCT03833167 — Phase 3

Frequently Asked Questions

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

Has the FDA given their blessing to Pembrolizumab 400 mg?

"Pembrolizumab 400 mg is part of a Phase 3 clinical trial, meaning that there is some evidence for its efficacy and it has undergone multiple rounds of testing for safety. Because of this, our team at Power rates its safety as a 3."

Answered by AI

Are there other Pembrolizumab 400 mg clinical trials that have completed or are ongoing?

"Pembrolizumab 400 mg was first researched in 2010 at City of Hope. Since that time, 18527 studies have been completed with pembrolizumab. Right now, there are 1000 active clinical trials using this medication; a significant number of these are located in Montreal, Quebec."

Answered by AI

Is this trial widespread throughout the United States?

"Currently, this study has recruited 24 patients from locations including CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0163) in Montreal, McGill University Health Centre ( Site 0162) in Montréal, and University of Colorado Cancer Center ( Site 1506) in Aurora. There are plans to expand the trial to include other sites."

Answered by AI

Why is Pembrolizumab 400 mg prescribed so often?

"Pembrolizumab 400 mg is a medication that oncologists commonly prescribe to treat malignant neoplasms. It can also help patients with unresectable melanoma, microsatellite instability high, and disease progression after chemotherapy."

Answered by AI

Are we still looking for volunteers for this experiment?

"Yes, the trial is presently looking for recruits according to information on clinicaltrials.gov. This particular study was first posted on April 1st 2019 with a recent update occurring on November 10th 2022. There are 24 different locations where this trial is being conducted and they are hoping to enroll 570 patients in total."

Answered by AI

How many test subjects are a part of this research?

"That is accurate. The clinicaltrials.gov website does show that this research project, which was originally announced on April 1st 2019, is still open for enrollment. There are 570 total spots available at the 24 different facilities conducting this trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pembrolizumab (MK-3475) Versus Placebo Following Surgery and Radiation in Participants With Locally Advanced Cutaneous Squamous Cell Carcinoma (MK-3475-630/KEYNOTE-630)

2019. "Pembrolizumab (MK-3475) Versus Placebo Following Surgery and Radiation in Participants With Locally Advanced Cutaneous Squamous Cell Carcinoma (MK-3475-630/KEYNOTE-630)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03833167.

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