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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 84 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 84 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 84 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pathologic Complete Response (pCR)
Secondary outcome measures
1-year OS
1-year PRS
2-year OS
+6 moreSide effects data
From 2022 Phase 2 trial • 80 Patients • NCT0409964134%
Decreased appetite
33%
Fatigue
30%
Nausea
26%
Constipation
26%
Diarrhoea
25%
Vomiting
23%
Anaemia
21%
Abdominal pain
18%
Dyspnoea
16%
Oedema peripheral
16%
Weight decreased
15%
Pyrexia
15%
Dizziness
13%
Alanine aminotransferase increased
13%
Aspartate aminotransferase increased
13%
Abdominal pain upper
13%
Chills
11%
Gastric cancer
11%
Hypothyroidism
11%
Headache
11%
Hypertension
11%
Myalgia
11%
Arthralgia
10%
Asthenia
10%
Hypoalbuminaemia
10%
Abdominal distention
10%
Back pain
8%
Depression
8%
Insomnia
8%
Ascites
8%
Dysphagia
8%
Urinary tract infection
8%
Muscular weakness
8%
Rash
7%
Dyspepsia
7%
Fall
7%
Hyponatraemia
7%
Pleural effusion
7%
Blood alkaline phosphatase increased
7%
Blood creatinine increased
5%
Dysuria
5%
Hyperkalaemia
5%
Hypotension
5%
Dry skin
5%
Infusion related reaction
5%
Abdominal discomfort
3%
Upper gastrointestinal haemorrhage
3%
Dehydration
3%
Death
3%
Hypokalaemia
3%
Generalized oedema
3%
Cough
3%
Vision blurred
3%
Peripheral sensory neuropathy
3%
Blood bilirubin increased
3%
Hypophosphataemia
2%
Multiple organ dysfunction syndrome
2%
Atrioventricular block
2%
Biliary tract infection
2%
Cancer pain
2%
Metastatic gastric cancer
2%
Disease progression
2%
Acute myocardial infarction
2%
Corona virus infection
2%
Oesophageal cancer metastatic
2%
Encephalopathy
2%
Acute respiratory failure
2%
Facial paralysis
2%
Loss of consciousness
2%
Transient ischaemic attack
2%
Acute kidney injury
2%
Malignant urinary tract obstruction
2%
Gastrointestinal haemorrhage
2%
Pneumonia aspiration
2%
Pneumonitis
2%
Hypoxia
2%
Respiratory failure
2%
Upper respiratory tract infection
2%
Pelvic pain
2%
Neutrophil count decreased
2%
Blood cholesterol increased
2%
Large intestinal obstruction
2%
Obstruction gastric
2%
Cardiac arrest
2%
Malignant ascites
2%
Urinary tract obstruction
2%
Benign prostatic hyperplasia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 1 (CPI Naïve)
Group 2 (CPI Relapse)
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
~120
Find a Location
Who is running the clinical trial?
Diwakar DavarLead Sponsor
10 Previous Clinical Trials
381 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,055,053 Total Patients Enrolled
Diwaker Davar, MD, M.ScPrincipal InvestigatorUPMC Hillman Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My organs are functioning well.I agree to use contraception and not donate sperm for 120 days after my last treatment dose.I am not pregnant or breastfeeding and either cannot become pregnant or agree to use birth control during and after the study.You have mental health or drug problems that might make it difficult for you to follow the study's requirements.I have been treated with specific immune therapy drugs before.I have had pneumonitis treated with steroids or have it now.I have not taken steroids or immunosuppressants in the last 7 days.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.You are currently in or have recently participated in a trial for a new medication or medical device.I have not received a live vaccine in the last 30 days.I have at least one tumor that can be measured.I am willing to have biopsies before treatment starts.I am fully active or restricted in physically strenuous activity but can do light work.I am currently being treated for an infection.I have active brain metastases or cancer in the lining of my brain.I have an active tuberculosis infection.I am 18 or older with a confirmed diagnosis of high-risk cSCC.My skin cancer is advanced or has spread to nearby lymph nodes.I haven't had cancer other than skin cancer in the last 3 years.I haven't had chemotherapy or targeted therapy in the last 2 weeks and have recovered from previous treatment side effects.I had radiotherapy less than 2 weeks before starting the study treatment.I have an autoimmune disease treated with medication in the last 2 years.I have a history of Hepatitis B or active Hepatitis C.I have received an organ or tissue transplant from another person.My tumor is located on my genitalia, hands, or feet and my doctor agrees I can join.
Research Study Groups:
This trial has the following groups:- Group 1: Pembrolizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What previous experiments have been done to assess the efficacy of Pembrolizumab Injection?
"As of today, 961 tests are being conducted on Pembrolizumab Injection. Of those trials, 122 have entered Phase 3 and 35727 sites across the world have been enlisted to participate in this research endeavour. Most notably, Houston Texas is a hub for clinical studies surrounding this medication."
Answered by AI
What safety measures should be considered when prescribing Pembrolizumab Injection?
"Our team's investigation of Pembrolizumab Injection lead to a safety rating of 2, as this Phase 2 trial has evidence supporting its security but not any data advocating for efficacy."
Answered by AI
For what maladies is Pembrolizumab Injection prescribed?
"Pembrolizumab Injection is an effective tool for fighting malignant neoplasms and has been shown to help manage unresectable melanoma, microsatellite instability high, and chemotherapy-induced disease progression."
Answered by AI
What is the scope of this experiment in terms of its participants?
"Affirmative. The information hosted on clinicaltrials.gov states that this scientific trial, which was first made visible on May 28th 2021, is actively recruiting patients. Approximately 30 individuals need to be recruited from 1 medical centre."
Answered by AI
Are there any open opportunities for enrolment in this trial?
"According to the information hosted on clinicaltrials.gov, this medical trial is actively recruiting patients, having first been posted on May 28th 2021 and most recently updated on June 21st 2022."
Answered by AI
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