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Checkpoint Inhibitor
Combination Immunotherapy for Stage III Melanoma
Phase 2
Recruiting
Led By Michael Egger, MD
Research Sponsored by University of Louisville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have measurable disease and have an injectable target lymph node for intralesional therapy administration
Stage III disease can be at time of diagnosis of primary melanoma or a recurrence after initial treatment of stage I-II disease.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 3-6 weeks during the combination treatment period, and every 3 months after surgery through study completion, up to 5 years
Awards & highlights
Study Summary
This trial is testing a combination of two immunotherapy drugs to treat resectable stage 3 melanoma. The goal is to see if the drugs are safe and effective.
Who is the study for?
Adults with stage III melanoma that can be surgically removed and have not been treated with T-VEC, pembrolizumab, or similar drugs. Participants must have good performance status, adequate organ function, measurable disease for injection therapy, and no history of certain autoimmune diseases or other cancers within the last three years.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of a combination immunotherapy (Talimogene Laherparepvec plus Pembrolizumab) given before surgery to remove lymph nodes affected by melanoma in patients who are at an advanced stage but not metastatic.See study design
What are the potential side effects?
Potential side effects include reactions at the injection site, flu-like symptoms such as fever and chills, fatigue, skin rash, nausea. There's also a risk of more serious immune-related adverse events affecting organs like lungs (pneumonitis), liver (hepatitis), intestines (colitis), hormone glands (endocrinopathies), or kidneys.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a cancer that can be measured and a lymph node that can be injected for treatment.
Select...
My melanoma was diagnosed at stage III or has returned to stage III after initial treatment.
Select...
My primary melanoma has been surgically removed.
Select...
I am fully active or can carry out light work.
Select...
I am 18 or older with a confirmed diagnosis of skin cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ every 3-6 weeks during the combination treatment period, and every 3 months after surgery through study completion, up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 3-6 weeks during the combination treatment period, and every 3 months after surgery through study completion, up to 5 years
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
Secondary outcome measures
Safety and Tolerability of Preoperative T-VEC/pembrolizumab: Adverse events and Serious Adverse Events
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: Combination T-VEC/PembrolizumabExperimental Treatment2 Interventions
Pre-operative talimogene laherparepvec (T-VEC) with Pembrolizumab
T-VEC - intra-lesional injection into palpable lymph nodes every 3 weeks for 6 months, or until complete response of target tumors.
Pembrolizumab - administered intravenously every 3 weeks for 6 months, then every 3 weeks for one year in the adjuvant setting following complete lymph node dissection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Talimogene Laherparepvec
2008
Completed Phase 3
~640
Find a Location
Who is running the clinical trial?
University of LouisvilleLead Sponsor
339 Previous Clinical Trials
76,652 Total Patients Enrolled
Michael Egger, MDPrincipal Investigator - University of Louisville
Saints Mary & Elizabeth Hospital, University of Louisville Hospital
Emory University School Of Medicine (Medical School)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have a history of serious autoimmune diseases or recent treatments for them.I have a cancer that can be measured and a lymph node that can be injected for treatment.My melanoma was diagnosed at stage III or has returned to stage III after initial treatment.My stage III melanoma is confirmed to be removable by surgery, as determined by a specialist.I don't have active herpes skin sores or need regular herpes medication.My primary melanoma has been surgically removed.I haven't had any cancer except for non-melanoma skin cancer in the last 3 years.My cancer has not spread to distant parts of my body.I am fully active or can carry out light work.My blood, liver, kidney, and clotting tests are normal.My melanoma is not located in mucosal tissues or the eye.I have not been treated with T-VEC, pembrolizumab, or any PD-1/L1/L2 inhibitors.I am 18 or older with a confirmed diagnosis of skin cancer.My cancer's BRAF status does not affect my eligibility.
Research Study Groups:
This trial has the following groups:- Group 1: Combination T-VEC/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.
Has Pembrolizumab obtained authorization from the Food and Drug Administration?
"Due to the lack of efficacy-supporting information, our team at Power assessed pembrolizumab's security with a score of 2."
Answered by AI
What is the capacity of this experiment in terms of participants?
"That is accurate. According to clinicaltrials.gov, this medical research project began recruiting on July 3rd 2019 and the information was last updated 16th of July 2022. 28 volunteers are needed for one site location only."
Answered by AI
Are there any other works that have been conducted using Pembrolizumab?
"Presently, there are 978 active clinical trials assessing the efficacy of Pembrolizumab; 122 of which have progressed to Phase 3. While Houston has a higher concentration of these studies, 35828 medical centres across the US offer this trial for those interested in participating."
Answered by AI
Are enrollees still being welcomed for this trial?
"The clinical trial registry on clinicaltrials.gov has verified that recruitment for this medical study is ongoing, with the initial post date being July 3rd 2019 and the latest update happening on July 16th 2022."
Answered by AI
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