Expanded Access Program of AMTAGVI That is Out of Specification for Commercial Release

Available (expanded access)

Conditions studied: Unresectable Melanoma, Metastatic Melanoma

In brief

The objective of this expanded access protocol is to provide access to Out Of Specification (OOS) AMTAGVI treatment to patients.

Key facts

Study ID

NCT05398640

Run by

Iovance Biotherapeutics, Inc.

Last updated by the study team

2026-04-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Eligible for treatment with AMTAGVI per United States Prescribing Information (USPI)
• Have an AMTAGVI product manufactured for commercial treatment; however, the final manufactured product did not meet commercial release criteria but was deemed safe and acceptable for release after risk/benefit assessment
• Patients of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control during treatment and for 12 months after receiving the last protocol-related therapy

You may not qualify if…

• History of hypersensitivity to cyclophosphamide, mesna, fludarabine, or any component of lifileucel cryopreservation medium
• Ongoing systemic infection
• Cardiopulmonary or renal disorder which may make patient ineligible for treatment with cyclophosphamide, fludarabine or IL-2, at the discretion of the Treating Physician
• Experience a significant worsening in clinical status that would, in the opinion of the Treating Physician, increase the risk of toxicities from treatment with lymphodepleting chemotherapy, AMTAGVI product that is out of specification, or IL-2
• Any other condition, laboratory abnormality and/or pre-treatment assessment that places patient at unacceptable risk if they were to participate in the EAP based on the Treating Physician's judgment
• Pregnant or breastfeeding

Where it is running

• Banner Health MD Anderson — Gilbert, Arizona, United States
• HonorHealth — Scottsdale, Arizona, United States
• City of Hope — Duarte, California, United States
• Stanford Hospital — Stanford, California, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• Yale New Haven Hospital — New Haven, Connecticut, United States
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• University of Miami — Miami, Florida, United States
• Orlando Health Cancer Institute — Orlando, Florida, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Northside Hospital — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• University of Iowa Hospital — Iowa City, Iowa, United States
• The University of Kansas Cancer Center — Westwood, Kansas, United States
• University of Kentucky-Markey Cancer Center — Lexington, Kentucky, United States
• University of Louisville - James Graham Brown Cancer Center — Louisville, Kentucky, United States
• University of Maryland — Baltimore, Maryland, United States
• The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Barbara Ann Karmanos Cancer Hospital — Detroit, Michigan, United States
• Washington University - Barnes Jewish Hospital — St Louis, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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