VX15/2503 With or Without Ipilimumab and/or Nivolumab in Patients With Resectable Stage IIIB-D Me… (NCT03769155) | Clinical Trial Compass
Active — Not RecruitingPhase 1
VX15/2503 With or Without Ipilimumab and/or Nivolumab in Patients With Resectable Stage IIIB-D Melanoma
United States41 participantsStarted 2018-12-13
Plain-language summary
This pilot phase I trial studies how well VX15/2503 (pepinemab) with or without ipilimumab and/or nivolumab work in treating participants with stage IIIB-D melanoma that can be removed by surgery. Monoclonal antibodies, such as VX15/2503, ipilimumab, and nivolumab may interfere with the ability of tumor cells to grow and spread.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 addition…
What they're measuring
1
Biomarker parameter analysis: extent of cluster of differentiation 8 (CD8)+ T cell infiltration between experimental groups following treatment