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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
Sponsor: Iovance Biotherapeutics, Inc.
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).
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
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
53
Start Date
2022-07-20
Completion Date
2027-06
Last Updated
2024-12-05
Healthy Volunteers
No
Conditions
Interventions
IOV-4001
A tumor sample is resected from each participant and cultured ex-vivo to manufacture IOV-4001. After lymphodepleting chemotherapy including cyclophosphamide and fludarabine, participant is infused with IOV-4001, and followed by IL-2.
Locations (10)
The Angeles Clinic and Research Institute
Los Angeles, California, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, 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
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States