Your session is about to expire
← Back to Search
Pembrolizumab + Radiation Therapy for Melanoma
Phase 2
Recruiting
Led By George Ansstas, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least 16 years of age
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 70%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is testing a new cancer treatment combining hypofractionated radiotherapy (HRT) with pembrolizumab. The goal is to see if this new treatment is more effective than HRT alone in controlling the tumor. Safety will also be monitored.
Who is the study for?
This trial is for adults with mucosal melanoma who've had surgery to remove it, have not had radiation in the affected area, and are generally healthy. They must understand the study and agree to use birth control. People with active autoimmune diseases, recent vaccines, certain infections or other cancers aren't eligible.Check my eligibility
What is being tested?
The study tests how well pembrolizumab (a drug) works with hypofractionated radiation therapy on mucosal melanoma compared to older treatments using only radiation. It's an early-phase trial without random assignment of patients.See study design
What are the potential side effects?
Pembrolizumab may cause immune system reactions affecting organs, infusion-related symptoms, fatigue, skin issues and can increase infection risk. Radiation might lead to localized skin damage and fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 16 years old or older.
Select...
I am mostly self-sufficient and can carry out daily activities.
Select...
I have not had radiation therapy on the area being studied.
Select...
My mucosal melanoma was confirmed by a lab test and has been surgically removed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Local tumor control rate
Secondary outcome measures
Distant metastasis-free survival
Number of treatment discontinuations due to treatment-related adverse events
Number of treatment-related grade 3 or greater adverse events
+2 moreSide effects data
From 2014 Phase 1 trial • 9 Patients • NCT00841555100%
Fatigue
67%
Vision changes
33%
Nausea
33%
Hypertension
33%
Dry skin
33%
Anorexia
33%
Alopecia
33%
Headache
33%
Constipation
33%
High ALT
33%
Insomnia
33%
Diarrhea
33%
Low Calcium
100%
80%
60%
40%
20%
0%
Study treatment Arm
50 mg/m2
65 mg/m2
75 mg/m2
Trial Design
1Treatment groups
Experimental Treatment
Group I: Pembrolizumab + Hypofractionated radiation therapyExperimental Treatment2 Interventions
Pembrolizumab will be given intravenously over 30 minutes (-5/+10 minutes) at a dose of 200 mg on an outpatient basis on Day 1 of each 21-day cycle for a total of up to 12 months (17 cycles).
Hypofractionated radiation therapy may be given at any point during the first 2 cycles of pembrolizuimab. It should begin within 90 days of surgical resection. Intensity modulated radiation therapy (IMRT) or intensity modulated proton therapy (IMPT) are to be used exclusively. IMRT or IMPT will be delivered twice per week in five fractions of 6 Gy given over 2.5 weeks totaling 30 Gy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Hypofractionated radiation therapy
2009
Completed Phase 2
~150
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,937 Previous Clinical Trials
2,299,739 Total Patients Enrolled
George Ansstas, M.D.Principal InvestigatorWashington University School of Medicine
2 Previous Clinical Trials
9 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not received a live vaccine in the last 30 days.People with HIV can join, but if their CD4+ T-cell counts are very low or if they had a serious infection related to AIDS in the past year, they can't join.I am 16 years old or older.I am mostly self-sufficient and can carry out daily activities.Your total bilirubin level is not more than 1.5 times the upper limit of normal at the institution where you are being treated.Your absolute neutrophil count should be at least 1,200 per microliter.I have been treated for an autoimmune disease in the last 2 years.I have not had radiation therapy on the area being studied.My mucosal melanoma was confirmed by a lab test and has been surgically removed.Your platelet count is at least 100,000 per microliter.My blood tests for bone marrow and organ function are normal.Your kidneys are working well enough to clear out waste products from your blood.Your liver enzyme levels are not more than 3 times the normal limit.I have or had lung inflammation needing high-dose steroids.I have received radiation therapy on the area being studied.I do not have any ongoing serious illnesses like heart problems or infections.I had cancer before, but I finished treatment over 2 years ago and am now cancer-free.My cancer has spread to other parts of my body.You have had allergic reactions to drugs similar to pembrolizumab or other drugs being used in the study.I have an immune system disorder or have been on steroids or other immune-weakening medicines in the last week.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there long-term repercussions to Hypofractionated radiation therapy?
"While Phase 2 trials don't have data supporting efficacy, there is some evidence indicating that hypofractionated radiation therapy is safe."
Answered by AI
How many volunteers are participating in this research project?
"That is correct. The trial, which began recruiting on May 29th 2020 and was last updated February 7th 2022, is looking for 16 patients from a single location."
Answered by AI
What cancerous tumors does Hypofractionated radiation therapy usually target?
"Hypofractionated radiation therapy can be used to target and treat malignant neoplasms, unresectable melanoma, and microsatellite instability high."
Answered by AI
Can new patients still sign up to participate in this research?
"The clinical trial is still recruiting patients, as seen on the website clinicaltrials.gov. The listing for this study was first posted on May 29th, 2020 and updated February 7th, 2022."
Answered by AI
Are there any precedent studies that have used Hypofractionated radiation therapy?
"Right now, there are 1000 ongoing clinical trials for Hypofractionated radiation therapy. 122 of these studies are in Phase 3. The majority of these Houston-based trials originated in Texas but there are 36053 locations running similar studies."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger