450 Participants Needed

Pembrolizumab for Squamous Cell Carcinoma

Recruiting at 193 trial locations
TF
Overseen ByToll Free Number
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Merck Sharp & Dohme Corp.
Stay on Your Current MedsYou can continue your current medications while participating
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a randomized, double-blind, study that compares pembrolizumab (MK-3475) with placebo given as adjuvant therapy in participants with high-risk locally advanced cutaneous squamous cell carcinoma (LA cSCC) that have undergone surgery with curative intent in combination with radiotherapy. The primary hypothesis is that pembrolizumab is superior to placebo in increasing recurrence free survival (RFS).

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have received certain cancer therapies or live vaccines recently, you may not be eligible to participate.

Is pembrolizumab safe for humans?

Pembrolizumab has been shown to have a manageable safety profile in various cancers, including squamous cell carcinoma, with some serious side effects like pneumonia and thyroid disorders. It is generally considered safe, but patients should be aware of potential immune-related side effects.12345

How does the drug pembrolizumab differ from other treatments for squamous cell carcinoma?

Pembrolizumab is unique because it is an immunotherapy drug that works by blocking the PD-1 receptor on T cells, which helps the immune system attack cancer cells more effectively. This mechanism is different from traditional chemotherapy, which directly targets and kills cancer cells.12367

What data supports the effectiveness of the drug pembrolizumab for squamous cell carcinoma?

Research shows that pembrolizumab has meaningful and lasting effects in treating recurrent or metastatic cutaneous squamous cell carcinoma, with a safety profile that is manageable.12589

Who Is on the Research Team?

MD

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I had surgery to remove all visible skin cancer, but some tiny cancer cells might remain.
Is not a woman of childbearing potential (WOCBP)
My cancer is a type of skin cancer that started in the skin cells.
See 10 more

Exclusion Criteria

Has a known history of human immunodeficiency virus (HIV) infection
I have received a transplant from another person.
I have a type of skin cancer that is not squamous cell carcinoma and it hasn't been fully treated.
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pembrolizumab or placebo by IV infusion every 42 days for up to 9 cycles

54 weeks
9 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to approximately 60 months

Open-label extension (optional)

Participants may receive up to 18 additional cycles of pembrolizumab if they experience biopsy-proven-disease recurrence

Long-term

What Are the Treatments Tested in This Trial?

Interventions

  • Pembrolizumab
  • Placebo
Trial Overview 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.
How Is the Trial Designed?
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Merck Sharp & Dohme Corp.

Lead Sponsor

Trials
2,287
Recruited
4,582,000+
Chirfi Guindo profile image

Chirfi Guindo

Merck Sharp & Dohme Corp.

Chief Medical Officer

Engineering degree from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis profile image

Robert M. Davis

Merck Sharp & Dohme Corp.

Chief Executive Officer since 2021

J.D. from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Merck Sharp & Dohme LLC

Lead Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis profile image

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Published Research Related to This Trial

In a phase III trial involving 1,019 patients with resected high-risk stage III melanoma, pembrolizumab significantly prolonged recurrence-free survival (RFS) compared to placebo, with a 3-year RFS rate of 63.7% versus 44.1%.
The benefits of pembrolizumab were consistent across various patient subgroups, including those with different tumor stages and BRAF mutation statuses, indicating its broad efficacy in this patient population.
Longer Follow-Up Confirms Recurrence-Free Survival Benefit of Adjuvant Pembrolizumab in High-Risk Stage III Melanoma: Updated Results From the EORTC 1325-MG/KEYNOTE-054 Trial.Eggermont, AMM., Blank, CU., Mandala, M., et al.[2023]
In a phase II trial involving 159 patients with locally advanced or recurrent/metastatic cutaneous squamous cell carcinoma, pembrolizumab showed significant antitumor activity, with an objective response rate of 50.0% in the locally advanced cohort and 35.2% in the recurrent/metastatic cohort.
The treatment demonstrated a manageable safety profile, with only 11.9% of patients experiencing grade 3-5 treatment-related adverse events, indicating that pembrolizumab is a promising and durable treatment option for cSCC.
Pembrolizumab for locally advanced and recurrent/metastatic cutaneous squamous cell carcinoma (KEYNOTE-629 study): an open-label, nonrandomized, multicenter, phase II trial.Hughes, BGM., Munoz-Couselo, E., Mortier, L., et al.[2022]
In a study of 39 patients with unresectable cutaneous squamous cell carcinomas (CSCCs), first-line treatment with pembrolizumab showed an objective response rate of 41% at week 15, indicating significant anti-tumor activity, especially in patients with PD-L1 positive tumors (55% response rate).
The treatment was generally well-tolerated, with 71% of patients experiencing adverse events, but only 7% had severe (grade ≥ 3) side effects, suggesting that pembrolizumab has a manageable safety profile while providing durable responses in this patient population.
Phase II Study of Pembrolizumab As First-Line, Single-Drug Therapy for Patients With Unresectable Cutaneous Squamous Cell Carcinomas.Maubec, E., Boubaya, M., Petrow, P., et al.[2021]

Citations

Longer Follow-Up Confirms Recurrence-Free Survival Benefit of Adjuvant Pembrolizumab in High-Risk Stage III Melanoma: Updated Results From the EORTC 1325-MG/KEYNOTE-054 Trial. [2023]
Pembrolizumab for locally advanced and recurrent/metastatic cutaneous squamous cell carcinoma (KEYNOTE-629 study): an open-label, nonrandomized, multicenter, phase II trial. [2022]
Adjuvant pembrolizumab versus placebo in resected stage III melanoma (EORTC 1325-MG/KEYNOTE-054): health-related quality-of-life results from a double-blind, randomised, controlled, phase 3 trial. [2021]
Phase II Study of Pembrolizumab As First-Line, Single-Drug Therapy for Patients With Unresectable Cutaneous Squamous Cell Carcinomas. [2021]
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience. [2022]
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions. [2017]
FDA Approval Summary: Pembrolizumab for the Treatment of Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma with Disease Progression on or After Platinum-Containing Chemotherapy. [2019]
Pembrolizumab joins the anti-PD-1 armamentarium in the treatment of melanoma. [2017]
Programmed Death Ligand-1 Combined Positive Score Concordance and Interrater Reliability in Primary Tumors and Synchronous Lymph Node Metastases in Resected Cases of p16+ Oropharyngeal Squamous Cell Carcinoma. [2023]
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