Pembrolizumab 400 mg for Carcinoma, Squamous Cell

Phase-Based Estimates
2
Effectiveness
3
Safety
Chris OBrien Lifehouse ( Site 0051), Camperdown, Australia
Carcinoma, Squamous Cell+1 More
Pembrolizumab 400 mg - Biological
Eligibility
18+
All Sexes
Eligible conditions
Carcinoma, Squamous Cell

Study Summary

This study is evaluating whether a drug may help prevent recurrence of a type of skin cancer.

See full description

Eligible Conditions

  • Carcinoma, Squamous Cell
  • Carcinoma

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Compared to trials

Study Objectives

This trial is evaluating whether Pembrolizumab 400 mg will improve 1 primary outcome and 5 secondary outcomes in patients with Carcinoma, Squamous Cell. Measurement will happen over the course of Up to approximately 38 months.

Month 60
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
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score
Month 38
Percentage of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
Month 60
Overall Survival (OS)
Recurrence-Free Survival (RFS) as Assessed by the Investigator and Confirmed by Biopsy
Month 63
Percentage of Participants Who Experience an Adverse Event (AE)

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Compared to trials

Trial Design

2 Treatment Groups

Placebo
Pembrolizumab
Placebo group

This trial requires 570 total participants across 2 different treatment groups

This trial involves 2 different treatments. Pembrolizumab 400 Mg is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Pembrolizumab
Biological
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.
Placebo
Drug
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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to approximately 63 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to approximately 63 months for reporting.

Closest Location

UF Health ( Site 1511) - Gainesville, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Has histologically confirmed LA cSCC with ≥1 high-risk feature(s) as the primary site of malignancy
Has completed adjuvant radiotherapy (RT) for LA cSCC with last dose of RT ≥4 weeks and ≤16 weeks from randomization
You have received an adequate post-op dose of RT. show original
Is not pregnant or breastfeeding
Has a negative pregnancy test ≤72 hours before the first dose of study intervention.
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
You have cutaneous squamous cell carcinoma (cSCC) as the primary site of malignancy (metastatic skin involvement from another primary cancer or from an unknown primary cancer is not permitted). show original
You have undergone complete macroscopic resection of all known cSCC disease with or without microscopic positive margins show original
You are disease free as assessed by the investigator with complete radiographic staging assessment ≤28 days from randomization. show original
You are not a woman of childbearing potential. show original

Patient Q&A Section

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

What are common treatments for carcinoma, squamous cell?

Add answer

Cancers of the oral cavity and pharynx often present with distant metastases at diagnosis or in an advanced disease stage. Chemotherapy and surgical therapy, including debulking procedures, are a typical choice of second-line treatment. Advanced oral cancer may also be treated with the combined modality approach, using both surgery and chemotherapy.

Unverified Answer

What is carcinoma, squamous cell?

Add answer

A common misconception is, according to this definition, that the majority of malignant or invasive squamous or transitional cell cancers of the penis are in fact adenocarcinomas.

Unverified Answer

How many people get carcinoma, squamous cell a year in the United States?

Add answer

Around 26.2 million Americans developed carcinoma, squamous cell a year. The incidence rate increased as the age group became older. The incidence rates in females were higher than those in males over the age groups 16-19 and 40-44 years.\n

Unverified Answer

What are the signs of carcinoma, squamous cell?

Add answer

Signs of carcinoma, squamous cell, may include changes to the white blood cell count and liver abnormalities. This should prompt an urgent and thorough medical investigation. A biopsy of suspicious areas is essential to make a diagnosis of carcinoma, squamous cell.

Unverified Answer

What causes carcinoma, squamous cell?

Add answer

In developed countries, breast carcinoma is the most common invasive cancer. The incidence is inversely proportional to the use of diethrone (i.e. diethylstilbestrol) during pregnancy as well as to parity and age of first pregnancy. Although, diethylstilbestrol was withdrawn from the drug-marketing-trnd in 1974, it is still detectable in the body and in breast milk. To minimize the risk of breast carcinoma development, a healthy postpartum breastfeeding should be recommended.

Unverified Answer

Can carcinoma, squamous cell be cured?

Add answer

Although some cancer patients may benefit from curative treatment procedures, many will not. Treatment decisions must be tailored to the specific illness of each patient and should incorporate medical information about the individual risk of treatment as well as the cost and side effects of treatment.

Unverified Answer

How quickly does carcinoma, squamous cell spread?

Add answer

The rate of clinical spread was the leading cause of death in patients with carcinoma, squamous cell epithelial cell. Carcinoma, squamous cell tissue spread within 10 months. Tumors invading the periosteum accounted for a minority of patients who died. The rate of spread of carcinoma, squamous epithelial cell in this population was only 6.9% over 15 years.

Unverified Answer

Is pembrolizumab 400 mg safe for people?

Add answer

People receiving 400-mg monthly pembrolizumab for 9 months had fewer treatment interruptions than people receiving 200-mg monthly, were more likely to complete 4-monthly assessments than people who received placebo, and had similar outcomes at 9 months on top of initial study completion.

Unverified Answer

What does pembrolizumab 400 mg usually treat?

Add answer

The treatment of choice depends on a person's age (older age, higher probability/severity of chemotherapy-induced myelosuppression), tumor size (>or = 5 cm), involvement of lymph nodes (lymphedema), chemotherapy history (chemotherapy-induced thrombocytopenia), and other clinical criteria. Therefore, pembrolizumab 400 mg should be administered only after discussion in an individualized, personalized treatment plan with a dermatologist and an oncologist.

Unverified Answer

What is pembrolizumab 400 mg?

Add answer

On the basis of phase III clinical trials, we consider cetuximab to be the most suitable first-line treatment for advanced NSCLC, even among those patients who received second-line treatment. Findings from a recent study are relevant in terms of the potential selection of first-line treatment of patients with NSCLC based to PD-L1 expression status.

Unverified Answer

Have there been any new discoveries for treating carcinoma, squamous cell?

Add answer

There are many drugs on the market that can help treat carcinoma patients, and there are still patients who will survive the disease long enough.

Unverified Answer

Who should consider clinical trials for carcinoma, squamous cell?

Add answer

Clinicians who specialize in oncology treatment should consider clinical trials on patients with early stage carcinoma who are receiving good chemotherapy, have not developed a progressive disease prior to entering clinical trials, and who have a high likelihood of being curable.

Unverified Answer
See if you qualify for this trial
Get access to this novel treatment for Carcinoma, Squamous Cell by sharing your contact details with the study coordinator.