Phase 12 Study of IOV-4001 Infusion for Adults with Unresectable or Metastatic Melanoma and Advanced Non-small-cell Lung Cancer

What this Trial Is About

Researchers are evaluating the safety and effectiveness of IOV-4001, a genetically modified tumor-infiltrating lymphocyte TIL therapy, in adults with unresectable or metastatic melanoma, or advanced non-small-cell lung cancer NSCLC. This first-in-human study aims to explore the potential of IOV-4001, which targets tumor cells and may offer enhanced activity by disrupting the PD-1 gene that normally inhibits immune response against tumors. Participants undergo a procedure where a tumor sample is removed and used to create the personalized IOV-4001 product. Before infusion, patients receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine. After the infusion of IOV-4001, they are followed by IL-2 treatment. The study includes two groups one with melanoma and one with NSCLC. Treatment and monitoring continue through Phase 1 and Phase 2 periods, with safety assessed up to one year and tumor response tracked for up to five years. During the study, participants will have assessments including cardiac and pulmonary function tests, evaluation of lesions, and organ function checks. Researchers will monitor tumor response, disease control, survival rates, and safety throughout follow-up visits that may last up to 60 months. Participants must practice effective birth control during treatment and for a year afterward. The study is open-label, non-randomized, and conducted in adults aged 18 to 70 years with a confirmed diagnosis of advanced melanoma or NSCLC.

A Study to Investigate the Efficacy and Safety of an Infusion of IOV-4001 in Adult Participants With Unresectable or Metastatic Melanoma or Stage III or IV Non-small-cell Lung Cancer