A Study to Investigate the Efficacy and Safety of an Infusion of IOV-4001 in Adult Participants With Unresectable or Metastatic Melanoma or Stage III or IV Non-small-cell Lung Cancer

Last updated: December 4, 2024
Sponsor: Iovance Biotherapeutics, Inc.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Metastatic Melanoma

Melanoma

Treatment

IOV-4001

Clinical Study ID

NCT05361174
IOV-GM1-201
  • Ages 18-70
  • All Genders

Study Summary

This is a study to investigate the efficacy and safety of an infusion of IOV-4001 in adult participants with unresectable or metastatic melanoma or advanced non-small-cell lung cancer (NSCLC).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participants must have a confirmed diagnosis of Stage IIIC, IIID, or IV unresectableor metastatic melanoma or Stage III or IV NSCLC.

  2. Participants who have received the following previous therapy:

  3. Cohort 1 (Melanoma): Participants who have progressed within 12 weeks of lastdose of anti-PD-1/PD-L1 blocking antibody and received BRAF/MEK inhibitor inthose with BRAF mutations.

  4. Cohort 2 (NSCLC): Participants who should have received no more than 3 priorlines of therapy and:

  • those without oncogene-driven tumors: Have progressed within 12 weeksafter last dose of anti-PD-1/PD-L1 blocking antibody
  • those with oncogene-driven tumors: Have progressed during/after ≥1targeted therapy AND either:
  • platinum doublet chemotherapy
  • Or within 12 weeks after last dose of anti-PD-1/PD-L1 blockingantibody
  1. Participants who have an Eastern Cooperative Oncology Group (ECOG) performancestatus of 0 or 1.

  2. Participants who is assessed as having at least one resectable lesion.

  3. Participants who have at least one measurable lesion, following resection of thelesion for IOV-4001 generation.

  4. Participants who have adequate organ function.

  5. Cardiac function test required.

  6. Pulmonary function test may be required.

  7. Participants of childbearing potential or those with partners of childbearingpotential must be willing to practice an approved method of highly effective birthcontrol during treatment and up to 12 months.

  8. Participants who are >70 years of age may be allowed to enroll after theinvestigator discusses with the medical monitor.

Exclusion

Exclusion Criteria:

  1. Participants who have melanoma of uveal/ocular origin.

  2. Participants who have symptomatic untreated brain metastases.

  3. Participants who have had a history of allogeneic organ transplant or any form ofcell therapy involving prior conditioning chemotherapy within the past 20 years.

  4. Participants who require systemic steroid therapy 10 mg/day prednisone or anothersteroid equivalent dose.

  5. Participants who have any form of primary immunodeficiency.

  6. Participants who have another primary malignancy within the previous 3 years.

  7. Participants who have received or will receive a live or attenuated vaccinationwithin 28 days prior to the start of the NMA-LD.

Study Design

Total Participants: 53
Treatment Group(s): 1
Primary Treatment: IOV-4001
Phase: 1/2
Study Start date:
July 20, 2022
Estimated Completion Date:
June 30, 2027

Study Description

This study is the first-in-human study of IOV-4001, a genetically modified autologous tumor- infiltrating lymphocytes (TIL) product. IOV-4001 is expected to have antitumor activity through its capacity to directly target and kill tumor cells in a manner that is similar to non-genome-edited TIL, but with the potential for enhanced antitumor activity due to disruption of PDCD1, the gene for programmed cell death protein-1 (PD-1).

Connect with a study center

  • The Angeles Clinic and Research Institute

    Los Angeles, California 90025
    United States

    Active - Recruiting

  • Sylvester Comprehensive Cancer Center

    Miami, Florida 33136
    United States

    Active - Recruiting

  • Orlando Health Cancer Institute

    Orlando, Florida 32610
    United States

    Active - Recruiting

  • Moffitt Cancer Center

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • The University of Kansas Cancer Center

    Westwood, Kansas 66205
    United States

    Active - Recruiting

  • University of Louisville

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

  • University of Cincinnati

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania 15232
    United States

    Active - Recruiting

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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