Spots Global Cancer Trial Database for 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
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Trial Identification
Brief Title: 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
Official Title: A Phase 1/2, Open-label Study of PD-1 Knockout Tumor-infiltrating Lymphocytes (IOV-4001) in Participants With Unresectable or Metastatic Melanoma or Stage III or IV Non-small-cell Lung Cancer
Study ID: NCT05361174
Interventions
Study Description
Brief Summary: This is a study to investigate the efficacy and safety of an infusion of IOV-4001 in adult participants with unresectable or metastatic melanoma or advanced non-small-cell lung cancer (NSCLC).
Detailed Description: This study is the first-in-human study of IOV-4001, a genetically modified autologous tumor- infiltrating lymphocytes (TIL) product. IOV-4001 is expected to have antitumor activity through its capacity to directly target and kill tumor cells in a manner that is similar to non-genome-edited TIL, but with the potential for enhanced antitumor activity due to disruption of PDCD1, the gene for programmed cell death protein-1 (PD-1).
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The Angeles Clinic and Research Institute, Los Angeles, California, United States
Orlando Health Cancer Institute, Orlando, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
The University of Kansas Cancer Center, Westwood, Kansas, United States
University of Louisville, Louisville, Kentucky, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
University of Cincinnati, Cincinnati, Ohio, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Contact Details
Name: Iovance Biotherapeutics Study Team
Affiliation: Iovance Biotherapeutics
Role: STUDY_DIRECTOR
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