New drug combo shows promise in early trial for advanced melanoma
NCT ID NCT03769155
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial is testing whether adding an experimental drug called VX15/2503 to standard immunotherapies (ipilimumab or nivolumab) can help treat stage IIIB-D melanoma that can be removed by surgery. About 41 participants will receive the drug combination before surgery to see how it affects immune cells in the tumor. The goal is to find better ways to shrink or control the cancer before surgical removal.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- VX15/2503 (pepinemab) combined with ipilimumab or nivolumab
- What this could lead to
- If successful, this could point toward a more effective treatment approach for advanced melanoma that can be surgically removed.
- What could go wrong
- This is an early phase 1 trial with only 41 participants, so results are preliminary and may not lead to a standard treatment. Side effects from the drug combination are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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41 people
The number who actually took part.
- Started
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Dec 2018
- Expected to finish
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Dec 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Stage IIIB, IIIC, IIID histologically-proven melanoma. * Cancer confirmed to be surgically resectable, with surgery evaluation with planned prior to resection. * No prior immunotherapy with cytotoxic T-lymphocyte associated protein-4 (CTLA-4), anti programmed cell death-1 (PD-1) or VX15/2503. Prior interferon (at least 1 year prior to consent) will be allowed. * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. * Absolute neutrophil count ≥ 1,500 cells/µL. * Platelets ≥ 100,000/µL. * Hemoglobin ≥ 9.0g/dL (may receive packed red blood cells \[PRBC\] transfusion). * Total bilirubin ≤ 1.5 x the upper limit of normal (ULN). * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN. * Albumin ≥ 3.0 g/dL. * Serum creatinine ≤ 1.5 x ULN OR calculated creatinine clearance of ≥ 50 mL/min using Cockcroft-Gault formula. * International normalized ration (INR) ≤ 1.5. Anticoagulation is allowed only with low molecular weight heparin (LMWH). Patient receiving LMW heparin on stable therapeutic dose for more than 2 weeks or with factor Xa level \< 1.1 U/mL are allowed on the trial. * Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. * Ability to understand and willingness to sign a written informed consent document. * Female subjects of childbearing potential must agree to use adequate contraception (at least one highly effective method and one additional method of birth control at the same time or complete abstinence) prior to study entry, for the duration of study treatment and 5 months after last dose of study treatment. * Male subjects must agree to use adequate contraception (at least one highly effective method and one additional method of birth control at the same time or complete abstinence) prior to study entry, for the duration of study treatment and 7 months after last dose of study treatment. * Female subjects of childbearing age must have a negative serum pregnancy test at study entry. Exclusion Criteria: * Determined not to be a surgical candidate due to medical co-morbidities. * Treatment with chronic immunosuppressants (e.g., cyclosporine following transplantation). * Prior organ allograft or allogeneic bone marrow transplantation. * Subjects with active or history of immune mediated pneumonitis, colitis, hepatitis, endocrinopathy, nephritis, or skin reactions as these patients may be at increased risk for developing immune therapy-induced exacerbation or recurrence of their immune mediated disease, potentially delaying surgery. * Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. * Women who are pregnant or lactating. * 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. * Other medications, or severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study. * Clinical evidence of bleeding diathesis or coagulopathy. * Patients with prior malignancies, including pelvic cancer, are eligible if they have been disease free for \> 5 years. Patients with prior non-melanoma skin cancers and in situ carcinomas are eligible provided there was complete removal. * Active bacterial or fungal infections requiring systemic treatment within 7 days of treatment. * 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. * History of severe hypersensitivity reactions to other monoclonal antibodies. * Non-oncology vaccines within 28 days prior to or after any dose of ipilimumab. * Prisoners and subjects who are compulsory detained. * Patients with rapidly progressive disease.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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