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Monoclonal Antibodies
Pembrolizumab for Skin Cancer
Phase 2
Waitlist Available
Led By Michael Lowe, MD, MA
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male subjects must agree to use contraception.
Must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) performance scale.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months after treatment discontinuation
Awards & highlights
Study Summary
This trial looks at how well pembrolizumab works in treating patients with skin cancer that has spread. Monoclonal antibodies may help stop tumor cells from growing and spreading.
Who is the study for?
This trial is for adults with skin cancer that can't be cured by surgery or radiation. They should have a good performance status, stable organ and blood function, and no recent use of certain medications. Participants must not be pregnant, agree to contraception if applicable, and provide tissue samples.Check my eligibility
What is being tested?
The study tests pembrolizumab's effectiveness on advanced or metastatic skin cancer. It's a phase II trial where this monoclonal antibody is given to see how well it stops the growth and spread of tumor cells.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related side effects such as inflammation in various organs, fatigue, infusion reactions (like fever or chills), skin rash, liver enzyme changes, hormone gland problems (like thyroid dysfunction), and could potentially worsen pre-existing autoimmune diseases.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree to use birth control.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My skin cancer cannot be cured with surgery or radiation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 months after treatment discontinuation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months after treatment discontinuation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Response rate of pembrolizumab
Secondary outcome measures
Overall survival
Progression-free survival
Other outcome measures
Programmed death-ligand 1 (PD-L1) expression in tumor specimens
Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (pembrolizumab)Experimental Treatment1 Intervention
Patients receive pembrolizumab IV over 30 minutes on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Emory UniversityLead Sponsor
1,638 Previous Clinical Trials
2,560,521 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,055,046 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,697 Previous Clinical Trials
7,492,308 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had chemotherapy, targeted therapy, or radiation in the last 2 weeks.I have another cancer that is getting worse or needs treatment.I am not pregnant and agree to use birth control.I agree to use birth control.I have active brain metastases or cancer in the lining of my brain.I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.I have an active hepatitis B or C infection.I am fully active or restricted in physically strenuous activity but can do light work.I have had or currently have lung inflammation treated with steroids.I have an active case of tuberculosis.I have not received a live vaccine in the last 30 days.I agree to provide a recent biopsy of my tumor before starting treatment.I have an immune system disorder or have taken steroids in the past week.I have received a cancer treatment drug within the last 4 weeks.I am willing to have skin biopsies before and after treatment.I am currently being treated for an infection.My skin cancer cannot be cured with surgery or radiation.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (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.
Is recruitment for this experiment still open?
"As of now, this medical trial is not in need of participants. After being first made available on January 27th 2017 and last updated March 7th 2022, it has gone inactive. There are still 3,545 other studies actively enrolling patients today though."
Answered by AI
What other explorations have been made with Pembrolizumab?
"Currently, there are an astounding 961 investigations being conducted into the effects of Pembrolizumab. Of these studies, 122 are currently in their third phase. Although Houston is hosting a majority of the trials for this drug, researchers have set up shop at 35727 different locations worldwide."
Answered by AI
What illnesses is Pembrolizumab commonly administered to treat?
"Pembrolizumab is frequently employed to combat malignant neoplasms and other ailments such as advanced melanoma, microsatellite instability high disease, or chemotherapy relapse."
Answered by AI
How many participants are being monitored in this research initiative?
"As of now, this trial is not taking new candidates. It was initially posted on January 27th 2017 and last modified March 7th 2022. If you're interested in other studies, there are 2584 trials for carcinoma actively recruiting participants and 961 Pembrolizumab studies with open participant slots."
Answered by AI
Has the Federal Drug Administration authorized Pembrolizumab?
"Despite the lack of clinical data suggesting efficacy, there is enough evidence to suggest pembrolizumab is safe. Therefore, it was given a rating of 2 on our scale from 1-3."
Answered by AI
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