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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.

Must not have

Use of other investigational drugs (drugs not marked for any indication) within 28 days or at least 5 half-lives (whichever is longer) before study drug administration.

Uncontrolled intercurrent illness including, but not limited to, human immunodeficiency virus (HIV)-positive subjects receiving combination antiretroviral therapy, ongoing or active infection, symptomatic congestive heart failure (NYHA class III or IV), unstable angina pectoris, ventricular arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 8 weeks after surgery

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't taken any experimental drugs recently.

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I do not have any major health issues that could interfere with the study.

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I am on long-term immunosuppressants like cyclosporine.

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I cannot have surgery because of other health issues.

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My cancer is growing quickly.

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I am not pregnant or breastfeeding.

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I have had an organ or bone marrow transplant from another person.

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I have a bleeding disorder or a condition affecting blood clotting.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 weeks after surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Biomarker parameter analysis: extent of cluster of differentiation 8 (CD8)+ T cell infiltration between experimental groups following treatment

Secondary study objectives

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

2015

Completed Phase 3

~3420

Nivolumab

2015