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Monoclonal Antibodies
VX15/2503 + Immunotherapy for Skin Cancer
Phase 1
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
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Serum creatinine ≤ 1.5 x ULN OR calculated creatinine clearance of ≥ 50 mL/min using Cockcroft-Gault formula.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 weeks after surgery
Awards & highlights
Study Summary
This trial is testing VX15/2503 with or without ipilimumab and/or nivolumab to see if it can treat stage IIIB-D melanoma. Monoclonal antibodies may stop tumor cells from growing and spreading.
Who is the study for?
This trial is for adults with Stage IIIB-D melanoma that can be surgically removed. They must have certain blood cell counts, normal organ function tests, and agree to use contraception if of childbearing potential. Those who've had prior immunotherapy or certain other treatments are excluded, as well as those with severe medical conditions or a history of hypersensitivity to monoclonal antibodies.Check my eligibility
What is being tested?
The study is testing the effectiveness of VX15/2503 alone or combined with ipilimumab and/or nivolumab in treating resectable melanoma. These drugs are types of monoclonal antibodies that may prevent tumor growth by targeting specific cells.See study design
What are the potential side effects?
Potential side effects include immune-related reactions such as inflammation in organs like the liver or intestines, skin issues, hormone gland problems (like thyroid dysfunction), fatigue, infusion reactions from the drug entering the body, and possible increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
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My kidney function, measured by creatinine levels or clearance, is within the required range.
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My cancer can be removed with surgery, and I am scheduled for a surgery evaluation.
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My melanoma is at stage IIIB, IIIC, or IIID.
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I agree to use two forms of birth control or practice complete abstinence while on the study and for 7 months after.
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I haven't had immunotherapy with CTLA-4, PD-1, or VX15/2503 but may have had interferon over a year ago.
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I am of childbearing age and have a negative pregnancy test.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 8 weeks after surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 weeks after surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Biomarker parameter analysis: extent of cluster of differentiation 8 (CD8)+ T cell infiltration between experimental groups following treatment
Secondary outcome measures
Incidence of adverse events assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Overall survival (OS)
Progression-free survival (PFS)
+1 moreTrial Design
5Treatment groups
Experimental Treatment
Active Control
Group I: D (nivolumab, surgery)Experimental Treatment2 Interventions
Participants receive nivolumab IV over 30 minutes on days 1 and 21 and undergo between days 35-49.
Group II: C (VX15/2503, nivolumab, ipilimumab, surgery)Experimental Treatment4 Interventions
Participants receive VX15/2503 (pepinemab) IV over 60 minutes, nivolumab IV over 30 minutes, and ipilimumab IV over 30 minutes on days 1 and 21 and undergo between days 35-49.
Group III: B (VX15/2503, ipilimumab, surgery)Experimental Treatment3 Interventions
Participants receive VX15/2503 (pepinemab) IV over 60 minutes and ipilimumab IV over 30 minutes on days 1 and 21 and undergo surgery between days 35-49.
Group IV: A (VX15/2503, nivolumab, surgery)Experimental Treatment3 Interventions
Participants receive VX15/2503 (pepinemab) IV over 60 minutes and nivolumab IV over 30 minutes on days 1 and 21 and undergo surgery between days 35-49.
Group V: E (surgery)Active Control1 Intervention
Participants undergo surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
2014
Completed Phase 3
~2670
Nivolumab
2014
Completed Phase 3
~4750
VX15/2503
2012
Completed Phase 2
~400
Surgery
2000
Completed Phase 3
~2550
Find a Location
Who is running the clinical trial?
Vaccinex Inc.Industry Sponsor
11 Previous Clinical Trials
712 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,547 Total Patients Enrolled
Emory UniversityLead Sponsor
1,636 Previous Clinical Trials
2,560,532 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or restricted in physically strenuous activity but can do light work.I have or had immune-related lung, gut, liver, hormone glands, kidney, or skin conditions.My kidney function, measured by creatinine levels or clearance, is within the required range.My cancer can be removed with surgery, and I am scheduled for a surgery evaluation.My melanoma is at stage IIIB, IIIC, or IIID.Your bilirubin levels in your blood should not be higher than 1.5 times the normal limit.My blood clotting time is normal or near normal, and if I'm on blood thinners, it's only low molecular weight heparin.Your blood platelet count is at least 100,000 per microliter.You have enough infection-fighting white blood cells in your body.I have been cancer-free for over 5 years, or I had non-melanoma skin cancer/in situ carcinoma that was completely removed.I am willing and able to follow the study's schedule and procedures.I haven't taken high-dose steroids or immunosuppressants in the last 14 days.I have not had serious infections needing treatment in the last week.My hemoglobin level is at least 9.0g/dL, even if I needed a blood transfusion.I agree to use two forms of birth control or practice complete abstinence while on the study and for 5 months after.I agree to use two forms of birth control or practice complete abstinence while on the study and for 7 months after.I haven't taken any experimental drugs recently.I do not have any major health issues that could interfere with the study.I am on long-term immunosuppressants like cyclosporine.I cannot have surgery because of other health issues.I haven't had immunotherapy with CTLA-4, PD-1, or VX15/2503 but may have had interferon over a year ago.My cancer is growing quickly.I am not pregnant or breastfeeding.Your levels of AST and ALT in the blood should be less than 2.5 times the normal limit.I haven't received vaccines other than for cancer within 4 weeks before or after getting ipilimumab.I have had an organ or bone marrow transplant from another person.I have a bleeding disorder or a condition affecting blood clotting.I am of childbearing age and have a negative pregnancy test.You have had serious allergic reactions to other types of antibodies in the past.Your albumin levels in your blood are higher than 3.0 grams per deciliter.
Research Study Groups:
This trial has the following groups:- Group 1: A (VX15/2503, nivolumab, surgery)
- Group 2: B (VX15/2503, ipilimumab, surgery)
- Group 3: C (VX15/2503, nivolumab, ipilimumab, surgery)
- Group 4: D (nivolumab, surgery)
- Group 5: E (surgery)
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.
Are there any other experiments which have been performed utilizing VX15/2503?
"Currently, 768 trials are being conducted to investigate the effects of VX15/2503. Of these active research projects, 86 have reached Phase 3. Most studies for this promising medication occur in Pittsburgh, Pennsylvania; however there are 42810 different centres running related clinical trials worldwide."
Answered by AI
To what extent is this experiment impacting the lives of participants?
"Affirmative. The clinical trial, which was initially posted on December 13th 2018 and most recently updated on February 11th 2022, is actively enrolling participants according to information available at clinicaltrials.gov. They require 42 patients from 1 centre for participation in the study."
Answered by AI
What potential hazards are associated with VX15/2503 treatment?
"As a Phase 1 trial, VX15/2503 has minimal evidence behind its safety and efficacy. Consequently, it was assigned a score of one on the scale."
Answered by AI
Is there an opportunity for new participants in this experimentation?
"Affirmative. According to the information available online, this clinical study commenced on December 13th 2018 and has been recently edited as of February 11th 2022. Currently it is enrolling 42 participants from one site."
Answered by AI
What is the primary purpose of VX15/2503?
"VX15/2503 has proven effective in treating prior anti-angiogenic therapy, malignant tumours, and non-operable melanomas."
Answered by AI
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