Specialties
- Hematology/Medical Oncology
Affiliated with
IOV-EAP-OO4 Melanoma
Full Clinical Trial Name
Clinical Trial
- Cancer
- Melanoma
Phase
Phase
1
Patient Type
Adult
Doctor(s) running this study
Location(s):
Description
The objective of this expanded access protocol is to provide access to Out Of Specification (OOS) AMTAGVI treatment to patients.
Eligibility
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Doctor(s) running this study