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Pembrolizumab for Squamous Cell Carcinoma

Phase 3

Waitlist Available

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

Must not have

Has had an allogeneic tissue/solid organ transplant

Has any other histologic type of skin cancer other than invasive cSCC (eg, basal cell carcinoma) that has not been definitively treated with surgery or radiation; Bowen's disease; Merkel cell carcinoma; or melanoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 63 months

Awards & highlights

Pivotal Trial

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have received a transplant from another person.

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I have a type of skin cancer that is not squamous cell carcinoma and it hasn't been fully treated.

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I have recovered from all side effects of radiation and have not had lung inflammation from it.

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I am currently being treated for an infection.

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I have been treated with specific immune therapy drugs before.

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I still have visible skin cancer after surgery or it has come back.

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I have or had lung inflammation that needed steroids.

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I have a history of hepatitis B or active hepatitis C.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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 / 13Eligibility criteria met