Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
- - 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.
- - 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.
- - 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.
- - 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.
- - 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.
- - 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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Michael Lowe, MD, MA|
|Principal Investigator Affiliation||Emory University|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Pathologic Stage IIIB Cutaneous Melanoma AJCC v8, Pathologic Stage IIIC Cutaneous Melanoma AJCC v8, Pathologic Stage IIID Cutaneous Melanoma AJCC v8|
- I. Evaluate the effect of VX15/2503 (pepinemab) in combination with immune checkpoint inhibitors on T cell infiltrate into the tumor microenvironment in involved and uninvolved lymph nodes and peripheral blood.
- I. Evaluate the effect of VX15/2503 in combination with immune checkpoint inhibitors on the immune profile of involved and uninvolved lymph nodes and peripheral blood.
- II. Assess safety and tolerability of profile and tolerability of single agent VX15/2503 to the combination of VX15/2503 and immune checkpoint inhibitors in patients with resectable metastatic melanoma.
- III. Document pathologic response rates of single agent VX15/2503 and combination VX15/2503 and immune checkpoint inhibitors in patients with resectable melanoma.
- IV. Compare pathologic response to radiographic response using Response Evaluation Criteria in Solid Tumors (RECIST) criteria in patients receiving single agent VX15/2503 and combination VX15/2503 and immune checkpoint inhibitors in patients with resectable melanoma.
Experimental: A (VX15/2503, nivolumab, surgery)
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.
Experimental: B (VX15/2503, ipilimumab, surgery)
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.
Experimental: C (VX15/2503, nivolumab, ipilimumab, surgery)
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.
Experimental: D (VX15/2503, surgery)
Participants receive VX15/2503 (pepinemab) IV over 60 minutes on days 1 and 21 and undergo between days 35-49.
Active Comparator: E (surgery)
Participants undergo surgery.
Biological: - Ipilimumab
Biological: - Nivolumab
Biological: - VX15/2503
Procedure: - Surgery
Undergo therapeutic conventional surgery
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.