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

Conditions
Unresectable Melanoma
Metastatic Melanoma
Registration Number
NCT05398640
Lead Sponsor
Iovance Biotherapeutics, Inc.
Brief Summary

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

Detailed Description

This program provides access to OOS AMTAGVI (lifileucel) that does not meet commercial release criteria but does meet Iovance clinical trial release criteria. Patients will be followed for safety and efficacy.

Recruitment & Eligibility

Status
AVAILABLE
Sex
All
Target Recruitment
Not specified
Inclusion Criteria
  1. Eligible for treatment with AMTAGVI per United States Prescribing Information (USPI)
  2. 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
  3. 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
  1. History of hypersensitivity to cyclophosphamide, mesna, fludarabine, or any component of lifileucel cryopreservation medium
  2. Ongoing systemic infection
  3. Cardiopulmonary or renal disorder which may make patient ineligible for treatment with cyclophosphamide, fludarabine or IL-2, at the discretion of the Treating Physician
  4. 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
  5. 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
  6. Pregnant or breastfeeding

Study & Design

Study Type
EXPANDED_ACCESS
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (33)

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, District of Columbia, United States

Orlando Health Cancer Institute

🇺🇸

Orlando, Florida, United States

Northside Hospital

🇺🇸

Atlanta, Georgia, United States

Northwestern University

🇺🇸

Chicago, Illinois, United States

University of Chicago

🇺🇸

Chicago, Illinois, United States

Scroll for more (23 remaining)
HonorHealth
🇺🇸Scottsdale, Arizona, United States

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