Pembrolizumab Injection for Carcinoma, Squamous Cell

Phase-Based Estimates
1
Effectiveness
2
Safety
UPMC Hillman Cancer Center, Pittsburgh, PA
Carcinoma, Squamous Cell+2 More
Pembrolizumab Injection - Drug
Eligibility
18+
All Sexes
Eligible conditions
Carcinoma, Squamous Cell

Study Summary

This study is evaluating whether a new drug may help prevent cancer from returning after surgery.

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Eligible Conditions

  • Carcinoma, Squamous Cell
  • Carcinoma
  • Squamous Cell Carcinoma (SCC)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Pembrolizumab Injection will improve 1 primary outcome and 9 secondary outcomes in patients with Carcinoma, Squamous Cell. Measurement will happen over the course of Up to 6 months.

Month 24
Pathologic Complete Response (pCR)
Pathologic Response
Up to 12 months
1-year OS
1-year PRS
Up to 24 months
2-year OS
2-year PFS
Up to 36 months
3-year PFS
Up to 6 months
6-month PFS
Up to 60 months
Progression-free Survival (PFS)
Up to 84 months
Overall Survival (OS)

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Control
Pembrolizumab

This trial requires 30 total participants across 2 different treatment groups

This trial involves 2 different treatments. Pembrolizumab Injection is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Pembrolizumab
Drug
Neoadjuvant Phase: 200 mg IV infusion, every 3 weeks (Day 1 of each 3-week cycle, 2 cycles) Adjuvant Phase: Day 1 of each 3-week cycle, 15 cycles
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 84 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 84 months for reporting.

Closest Location

UPMC Hillman Cancer Center - Pittsburgh, PA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Carcinoma, Squamous Cell or one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
1. Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of high-risk localized or locooregional cSCC as defined below may be enrolled in this study.
NOTE: Patients are eligible for this trial either at initial presentation for cSCC with locally advanced and/or concurrent regional nodal metastasis; or at the time of recurrence with locally advanced and/or concurrent regional nodal metastasis assuming following criteria are met per the cSCC-specific AJCC UICC 8th edition staging classification
Tumor size > 2 cm and ≤ 4 cm in greatest dimension. show original
You have a tumor that is 4 cm or larger or has a minor bone erosion or perineural invasion or deep invasion. show original
Deep invasion is defined as invasion beyond the subcutaneous fat or >6 mm (as measured from the granular layer of adjacent normal epidermis to the base of the tumor).
The tumor must be located within the nerve sheath of a nerve lying deeper than the dermis or presenting with clinical or radiographic involvement of named nerves without skull base invasion or transgression. show original
iii. T4 and Nx and M0 (tumor with gross cortical bone/marrow, skull base invasion and/or skull base foramen invasion if deemed surgically resectable) OR;
iv. Tx and N1-3 and M0 (if deemed surgically resectable) OR;
i. If T2, tumors must possess ≥2 NCCN/BWH clinical or pathologic risk factor(s) as stated below.
1. Tumors ≥20 mm on trunk or extremities (excluding pretibia, hands, feet, nail units, and ankles).

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 is pembrolizumab injection?

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A combination of cisplatin and pembrolizumab is effective at achieving and maintaining disease-free survival in a subset of patients with metastatic papillary serous ovarian carcinoma.

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Can carcinoma, squamous cell be cured?

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SCC did well but the rate of SCC relapse was high and the OS was poor. T3N0M0 could not be completely eliminated after surgical resection.

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What are common treatments for carcinoma, squamous cell?

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Some cancers have specific treatment approaches. One of the more frequent treatment options for those with carcinoma, squamous cell cancer, is surgical resection with or without radiotherapy and/or chemotherapy. The most common treatments for squamous cell carcinomas of the lung, vulva, head, neck, and anus include hormonal therapy in combination with surgery.

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What causes carcinoma, squamous cell?

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The development of squamous cell carcinoma of the cervix is strongly associated with tobacco smoking. To our knowledge, this study provides the first direct epidemiologic evidence that exposure to specific carcinogens may be directly associated with particular types of cancer.

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What are the signs of carcinoma, squamous cell?

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Signs of carcinoma, squamous cell include the development of hard bumps and nodules. On CT scan, these might be found in the chest, neck, breast or brain. They are usually accompanied by the symptoms of lung cancer (pneumonia and pleuritic chest pain).

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What is carcinoma, squamous cell?

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Carcinoma, squamous cell is the most expensive form of cancer because chemotherapy and radiation are employed. The highest rates of skin cancer are associated with sun exposure and are the second most common cause of death from cancer. Carcinoma, squamous cell remains a major cause of cancer morbidity, accounting for almost 50% of cases. Carcinoma, squamous cell remains a major cause of cancer morbidity worldwide.

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

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About 125,000 cases of carcinoma, squamous cell are diagnosed each year in the United States. It is the fourth leading cause of death from cancer in men and causes more deaths than breast, colorectal, or lung cancers combined.

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What are the chances of developing carcinoma, squamous cell?

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A significant number of CVS patients are diagnosed with and manage to eradicate the chronic form of the illness by employing a variety of treatment strategies. Despite the existence of specific and sophisticated management approaches, the rate of malignancy remains extremely high for CVS patients. It is important to recognize the correct clinical, pathological, and psychological/affective conditions that can contribute to the development of cancer in CVS.

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Is pembrolizumab injection safe for people?

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Injection of a systemic antibody for cancer or an antibody to a viral antigen are major risk events, requiring treatment. After injection of a systematic antibody, people can still feel some symptom of their disease, including inflammation, or soreness at the injection site. Symptoms usually resolve, but they can be persistent and disabling.

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What is the latest research for carcinoma, squamous cell?

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The first question for metastasise research. (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6259402/) After the metastasisation, metastasis, invasion, intravase and extravase and the biological behavior of carcinoma, squamous cell are discussed. (http://www.carcinomed.com/~/media/news/news/articles/2013/09/metastasise_research_carcinoma_squamous_cell.html) I think the main feature of carcinoma and squamous cell is the metastase; therefore, this chapter focuses on the study of metastasis carcinoma (a)(I.

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Who should consider clinical trials for carcinoma, squamous cell?

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It seems clear and consistent that in the era of personalized medicine, patients with carcinoma, squamous cell are an increasing concern among oncologists. As for other cancers, we found strong evidence for using clinical trials to search for appropriate biomarkers for personalized treatment.

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What is the survival rate for carcinoma, squamous cell?

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[The average survival rate of patients in the United States is 18.3 months. Patients who have carcinoma, squamous cell, are at a [2-fold higher risk of dying, compared with patients without the disease]. For comparison, the average survival time in the United States is 2.7 months. For patients with carcinoma, squamous cell, the 2-year survival rate is 23.3% compared with 6.7% for patients without the disease.] You can find many of the most recent clinical trials tailored to your condition, location, and ideal treatment at [Power (https://www.withpower.com/clinical-trials/cancer-research.

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