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Cure My Disease

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Second chance: Out-of-Spec cancer therapy offered to desperate patients

NCT ID NCT05398640

Disease control Sponsor: Iovance Biotherapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access This study
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This program gives patients with advanced melanoma access to AMTAGVI, a cell therapy, even when the manufactured batch doesn't meet commercial standards but is still considered safe. It's for people who are already eligible for AMTAGVI and have a product made for them that failed quality checks. The goal is to provide a potential treatment option when no other commercial supply is available.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

melanoma metastatic melanoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic melanoma Unresectable melanoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    48 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Avera Cancer Institute

    AVAILABLE

    Sioux Falls, South Dakota, 57105, United States

  • Banner Health MD Anderson

    AVAILABLE

    Gilbert, Arizona, 85234, United States

  • Barbara Ann Karmanos Cancer Hospital

    AVAILABLE

    Detroit, Michigan, 48201, United States

  • City of Hope

    AVAILABLE

    Duarte, California, 91010, United States

  • Cleveland Clinic

    AVAILABLE

    Cleveland, Ohio, 44195, United States

  • Dana Farber Cancer Institute

    AVAILABLE

    Boston, Massachusetts, 02215, United States

  • Emory University Hospital

    AVAILABLE

    Atlanta, Georgia, 30322, United States

  • Fox Chase Cancer Center

    AVAILABLE

    Philadelphia, Pennsylvania, 19111, United States

  • Fred Hutchinson Cancer Research Center

    AVAILABLE

    Seattle, Washington, 98109, United States

  • Georgetown University Medical Center

    AVAILABLE

    Washington D.C., District of Columbia, 20007, United States

  • Hackensack University Medical Center

    AVAILABLE

    Hackensack, New Jersey, 07601, United States

  • HonorHealth

    AVAILABLE

    Scottsdale, Arizona, 85258, United States

  • Intermountain Healthcare

    AVAILABLE

    Salt Lake City, Utah, 84107, United States

  • Lehigh Valley Health Network

    AVAILABLE

    Allentown, Pennsylvania, 18105, United States

  • MD Anderson Cancer Center - U of Texas

    AVAILABLE

    Houston, Texas, 77030, United States

  • MD Anderson Cancer Center at Cooper

    AVAILABLE

    Camden, New Jersey, 08103, United States

  • Massachusetts General Hospital

    AVAILABLE

    Boston, Massachusetts, 02114, United States

  • Medical College of Wisconsin

    AVAILABLE

    Milwaukee, Wisconsin, 53226, United States

  • Memorial Sloan Kettering Cancer Center

    AVAILABLE

    New York, New York, 10065, United States

  • Moffitt Cancer Center

    AVAILABLE

    Tampa, Florida, 33612, United States

  • New York Presbyterian Weill Cornell Medical Center

    AVAILABLE

    New York, New York, 10065, United States

  • Northside Hospital

    AVAILABLE

    Atlanta, Georgia, 30342, United States

  • Northwestern University

    AVAILABLE

    Chicago, Illinois, 60611, United States

  • Oregon Health and Science University

    AVAILABLE

    Portland, Oregon, 97239, United States

  • Orlando Health Cancer Institute

    AVAILABLE

    Orlando, Florida, 32806, United States

  • Providence Cancer Center Oncology and Hematology Care Clinic

    AVAILABLE

    Portland, Oregon, 97213, United States

  • SCRI Oncology Partners

    AVAILABLE

    Nashville, Tennessee, 37203, United States

  • South Austin Medical Center

    AVAILABLE

    Austin, Texas, 78704, United States

  • St. Lukes Hospital

    AVAILABLE

    Bethlehem, Pennsylvania, 18015-1000, United States

  • Stanford Hospital

    AVAILABLE

    Stanford, California, 94305, United States

  • Texas Oncology-Baylor Charles A. Sammons Cancer Center

    AVAILABLE

    Dallas, Texas, 75246, United States

  • The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    AVAILABLE

    Baltimore, Maryland, 21287-0013, United States

  • The University of Kansas Cancer Center

    AVAILABLE

    Westwood, Kansas, 66205, United States

  • Thomas Jefferson University

    AVAILABLE

    Philadelphia, Pennsylvania, 19701, United States

  • University of Chicago

    AVAILABLE

    Chicago, Illinois, 60637, United States

  • University of Colorado Hospital

    AVAILABLE

    Aurora, Colorado, 80045, United States

  • University of Iowa Hospital

    AVAILABLE

    Iowa City, Iowa, 52242, United States

  • University of Kentucky-Markey Cancer Center

    AVAILABLE

    Lexington, Kentucky, 40536, United States

  • University of Louisville - James Graham Brown Cancer Center

    AVAILABLE

    Louisville, Kentucky, 40202, United States

  • University of Maryland

    AVAILABLE

    Baltimore, Maryland, 21201, United States

  • University of Miami

    AVAILABLE

    Miami, Florida, 33136, United States

  • University of Nebraska Medical Center

    AVAILABLE

    Omaha, Nebraska, 68198, United States

  • University of Pittsburgh Medical Center - Hillman Cancer Center

    AVAILABLE

    Pittsburgh, Pennsylvania, 15232, United States

  • VCU Medical Center (Virginia Commonwealth University)

    AVAILABLE

    Richmond, Virginia, 23298, United States

  • Vanderbilt University

    AVAILABLE

    Nashville, Tennessee, 37232, United States

  • Washington University - Barnes Jewish Hospital

    AVAILABLE

    St Louis, Missouri, 63110, United States

  • West Penn Hospital

    AVAILABLE

    Pittsburgh, Pennsylvania, 15224, United States

  • Yale New Haven Hospital

    AVAILABLE

    New Haven, Connecticut, 06510, United States

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