Unresectable MelanomaNCT05398640
Expanded Access Program of AMTAGVI That is Out of Specification for Commercial Release
A study testing OOS AMTAGVI in people with Unresectable Melanoma and Metastatic Melanoma, run by Iovance Biotherapeutics, Inc. at 48 sites in United States.
Trial summary
The objective of this expanded access protocol is to provide access to Out Of Specification (OOS) AMTAGVI treatment to patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Melanoma, Metastatic Melanoma
- What is being tested?
- OOS AMTAGVI
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 48 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
48 sites in 1 country.
48 sites in 1 country
United States48 sites
- Available
Lehigh Valley Health Network
Allentown, Pennsylvania, 18105
- Available
Emory University Hospital
Atlanta, Georgia, 30322
- Available
Northside Hospital
Atlanta, Georgia, 30342
- Available
University of Colorado Hospital
Aurora, Colorado, 80045
- Available
South Austin Medical Center
Austin, Texas, 78704
- Available
University of Maryland
Baltimore, Maryland, 21201
- Available
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287-0013
Stephanie Gaillard, Dr.
- Available
St. Lukes Hospital
Bethlehem, Pennsylvania, 18015-1000
- Available
Massachusetts General Hospital
Boston, Massachusetts, 02114
- Available
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
- Available
MD Anderson Cancer Center at Cooper
Camden, New Jersey, 08103
- Available
Northwestern University
Chicago, Illinois, 60611
- Available
University of Chicago
Chicago, Illinois, 60637
- Available
Cleveland Clinic
Cleveland, Ohio, 44195
- Available
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246
- Available
Barbara Ann Karmanos Cancer Hospital
Detroit, Michigan, 48201
- Available
City of Hope
Duarte, California, 91010
- Available
Banner Health MD Anderson
Gilbert, Arizona, 85234
- Available
Hackensack University Medical Center
Hackensack, New Jersey, 07601
- Available
MD Anderson Cancer Center - U of Texas
Houston, Texas, 77030
- Available
University of Iowa Hospital
Iowa City, Iowa, 52242
- Available
University of Kentucky-Markey Cancer Center
Lexington, Kentucky, 40536
- Available
University of Louisville - James Graham Brown Cancer Center
Louisville, Kentucky, 40202
- Available
University of Miami
Miami, Florida, 33136
- Available
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
- Available
SCRI Oncology Partners
Nashville, Tennessee, 37203
- Available
Vanderbilt University
Nashville, Tennessee, 37232
- Available
Yale New Haven Hospital
New Haven, Connecticut, 06510
- Available
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
- Available
New York Presbyterian Weill Cornell Medical Center
New York, New York, 10065
- Available
University of Nebraska Medical Center
Omaha, Nebraska, 68198
- Available
Orlando Health Cancer Institute
Orlando, Florida, 32806
- Available
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
- Available
Thomas Jefferson University
Philadelphia, Pennsylvania, 19701
- Available
West Penn Hospital
Pittsburgh, Pennsylvania, 15224
- Available
University of Pittsburgh Medical Center - Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
- Available
Providence Cancer Center Oncology and Hematology Care Clinic
Portland, Oregon, 97213
- Available
Oregon Health and Science University
Portland, Oregon, 97239
- Available
VCU Medical Center (Virginia Commonwealth University)
Richmond, Virginia, 23298
- Available
Intermountain Healthcare
Salt Lake City, Utah, 84107
- Available
HonorHealth
Scottsdale, Arizona, 85258
- Available
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
- Available
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
- Available
Washington University - Barnes Jewish Hospital
St Louis, Missouri, 63110
- Available
Stanford Hospital
Stanford, California, 94305
- Available
Moffitt Cancer Center
Tampa, Florida, 33612
- Available
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
- Available
The University of Kansas Cancer Center
Westwood, Kansas, 66205
About this study
The objective of this expanded access protocol is to provide access to Out Of Specification (OOS) AMTAGVI treatment to patients.
Read the 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.
- Conditions
- Unresectable Melanoma, Metastatic Melanoma
- Being tested
- OOS AMTAGVI
- Keywords
- LN-144, Lifileucel, Adoptive Cell Therapy, Cell Therapy, Tumor Infiltrating Lymphocytes, TIL, Immunotherapy
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OOS AMTAGVIBiological
Also called LN-144, Lifileucel
Patients will undergo preparative lymphodepleting chemotherapy. Infusion of lifileucel is then given and is followed by administration of IL-2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Iovance Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05398640
- Sponsor's protocol ID
- IOV-EAP 402
- Status last verified
- Apr 2026
- First submitted
- 26 May 2022
- Last updated
- 20 Apr 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Program of AMTAGVI That is Out of Specification for Commercial Release
- ClinicalTrials.gov ID
- NCT05398640
- Acronym / sponsor ID
- IOV-EAP 402
- Conditions
- Unresectable Melanoma, Metastatic Melanoma
- Keywords
- LN-144, Lifileucel, Adoptive Cell Therapy, Cell Therapy, Tumor Infiltrating Lymphocytes, TIL, Immunotherapy
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Iovance Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OOS AMTAGVIAlso: LN-144, LifileucelPatients will undergo preparative lymphodepleting chemotherapy. Infusion of lifileucel is then given and is followed by administration of IL-2. | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
48 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OOS AMTAGVI in people with Unresectable Melanoma and Metastatic Melanoma, run by Iovance Biotherapeutics, Inc. at 48 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Iovance Biotherapeutics Study Team (1 (844) 845-4682, clinical.inquiries@iovance.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.