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Immunotherapy for Skin Cancer

Phase 2
Waitlist Available
Led By Diwaker Davar, MD, M.Sc
Research Sponsored by Diwakar Davar
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have at least a single site of measurable disease based on RECIST 1.1
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Must not have
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137)
Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 84 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will test if a new immunotherapy drug can help patients with a certain type of skin cancer that has not been treated before. The study will last 52 weeks and will help researchers see if the drug could improve survival for patients with this type of skin cancer.

Who is the study for?
Adults with high-risk cutaneous squamous cell carcinoma (cSCC) that hasn't been surgically removed may join this trial. They must have measurable disease, be in good health otherwise, and women of childbearing age must agree to contraception. People can't join if they've had recent cancer treatments, immune system issues, certain other cancers within 3 years, or are pregnant.
What is being tested?
The study is testing Pembrolizumab injections as a pre-surgery treatment for cSCC over a year. It aims to see if the drug helps prevent cancer from coming back after surgery in patients who haven't received PD-1 inhibitors before.
What are the potential side effects?
Pembrolizumab might cause immune-related side effects like inflammation in various organs, skin reactions, fatigue, flu-like symptoms and potential infusion-related reactions. The severity of side effects varies among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have at least one tumor that can be measured.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am 18 or older with a confirmed diagnosis of high-risk cSCC.
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My skin cancer is advanced or has spread to nearby lymph nodes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been treated with specific immune therapy drugs before.
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I have had pneumonitis treated with steroids or have it now.
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I have not taken steroids or immunosuppressants in the last 7 days.
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I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.
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I am currently being treated for an infection.
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I have active brain metastases or cancer in the lining of my brain.
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I have an active tuberculosis infection.
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I have an autoimmune disease treated with medication in the last 2 years.
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I have a history of Hepatitis B or active Hepatitis C.
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I have received an organ or tissue transplant from another person.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 84 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 84 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
Pathologic Complete Response (pCR)
Secondary study objectives
1-year OS
1-year PRS
2-year OS
+6 more

Side effects data

From 2022 Phase 2 trial • 80 Patients • NCT04099641
34%
Decreased appetite
33%
Fatigue
30%
Nausea
26%
Diarrhoea
26%
Constipation
25%
Vomiting
23%
Anaemia
21%
Abdominal pain
18%
Dyspnoea
16%
Oedema peripheral
16%
Weight decreased
15%
Pyrexia
15%
Dizziness
13%
Aspartate aminotransferase increased
13%
Abdominal pain upper
13%
Alanine aminotransferase increased
13%
Chills
11%
Arthralgia
11%
Myalgia
11%
Gastric cancer
11%
Headache
11%
Hypertension
11%
Hypothyroidism
10%
Asthenia
10%
Back pain
10%
Abdominal distention
10%
Hypoalbuminaemia
8%
Insomnia
8%
Depression
8%
Ascites
8%
Urinary tract infection
8%
Dysphagia
8%
Muscular weakness
8%
Rash
7%
Fall
7%
Dyspepsia
7%
Blood creatinine increased
7%
Hyponatraemia
7%
Blood alkaline phosphatase increased
7%
Pleural effusion
5%
Hyperkalaemia
5%
Abdominal discomfort
5%
Dysuria
5%
Infusion related reaction
5%
Dry skin
5%
Hypotension
3%
Death
3%
Generalized oedema
3%
Hypophosphataemia
3%
Blood bilirubin increased
3%
Peripheral sensory neuropathy
3%
Hypokalaemia
3%
Cough
3%
Vision blurred
3%
Upper gastrointestinal haemorrhage
3%
Dehydration
2%
Encephalopathy
2%
Upper respiratory tract infection
2%
Facial paralysis
2%
Obstruction gastric
2%
Gastrointestinal haemorrhage
2%
Neutrophil count decreased
2%
Disease progression
2%
Respiratory failure
2%
Malignant urinary tract obstruction
2%
Acute respiratory failure
2%
Multiple organ dysfunction syndrome
2%
Large intestinal obstruction
2%
Corona virus infection
2%
Acute kidney injury
2%
Hypoxia
2%
Oesophageal cancer metastatic
2%
Loss of consciousness
2%
Blood cholesterol increased
2%
Pelvic pain
2%
Biliary tract infection
2%
Transient ischaemic attack
2%
Acute myocardial infarction
2%
Atrioventricular block
2%
Cardiac arrest
2%
Cancer pain
2%
Malignant ascites
2%
Metastatic gastric cancer
2%
Urinary tract obstruction
2%
Benign prostatic hyperplasia
2%
Pneumonia aspiration
2%
Pneumonitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 1 (CPI Naïve)
Group 2 (CPI Relapse)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: PembrolizumabExperimental Treatment1 Intervention
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab Injection
2019
Completed Phase 2
~290

Find a Location

Who is running the clinical trial?

Diwakar DavarLead Sponsor
11 Previous Clinical Trials
384 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
4,000 Previous Clinical Trials
5,181,802 Total Patients Enrolled
Diwaker Davar, MD, M.ScPrincipal InvestigatorUPMC Hillman Cancer Center

Media Library

Pembrolizumab Injection Clinical Trial Eligibility Overview. Trial Name: NCT04808999 — Phase 2
Squamous Cell Carcinoma Research Study Groups: Pembrolizumab
Squamous Cell Carcinoma Clinical Trial 2023: Pembrolizumab Injection Highlights & Side Effects. Trial Name: NCT04808999 — Phase 2
Pembrolizumab Injection 2023 Treatment Timeline for Medical Study. Trial Name: NCT04808999 — Phase 2
~7 spots leftby Nov 2025
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