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NCT05361174 | Recruiting | Unresectable Melanoma

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
Sponsor:

Iovance Biotherapeutics, Inc.

Brief 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).

Condition or disease

Unresectable Melanoma

Metastatic Melanoma

Stage III Non-small Cell Lung Cancer

Stage IV Non-small Cell Lung Cancer

Intervention/treatment

IOV-4001

Phase

Phase 1

Phase 2

Detailed 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).}}

Study Type : Interventional
Estimated Enrollment : 53 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : A Phase 1/2, Open-label Study of PD-1 Knockout Tumor-infiltrating Lymphocytes (IOV-4001) in Participants With Unresectable or Metastatic Melanoma or Stage III or IV Non-small-cell Lung Cancer
Actual Study Start Date : July 20, 2022
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : June 2027
Arm Intervention/treatment

Experimental: Cohort 1

Participants with unresectable or metastatic melanoma

Biological: IOV-4001

Experimental: Cohort 2

Participants with Stage III or IV non-small-cell lung cancer

Biological: IOV-4001
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Participants must have a confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma (Cohort 1) or Stage III or IV NSCLC (Cohort 2).
  • Participants who have received the following previous therapy
    • Cohort 1 (melanoma): Participants who have progressed within 12 weeks of last dose of anti-PD-1/PD-L1 blocking antibody and received BRAF/MEK inhibitor in those with BRAF mutations.
    • Cohort 2 (NSCLC): Participants who should have received no more than 3 prior lines of therapy and
      • those without oncogene-driven tumors: Have progressed within 12 weeks after last dose of anti-PD-1/PD-L1 blocking antibody
      • those with oncogene-driven tumors: Have progressed during/after ≥1 targeted therapy AND either
        • platinum doublet chemotherapy
        • Or within 12 weeks after last dose of anti-PD-1/PD-L1 blocking antibody
        • Participants who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
        • Participants who is assessed as having at least one resectable lesion.
        • Participants who have at least one measurable lesion, following resection of the lesion for IOV-4001 generation.
        • Participants who have adequate organ function.
        • Cardiac function test required.
        • Pulmonary function test may be required.
        • Participants 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 up to 12 months.
        Exclusion Criteria
        • Participants who have melanoma of uveal/ocular origin.
        • Participants who have symptomatic untreated brain metastases.
        • Participants who have had a history of allogeneic organ transplant or any form of cell therapy involving prior conditioning chemotherapy within the past 20 years.
        • Participants who require systemic steroid therapy > 10 mg/day prednisone or another steroid equivalent dose.
        • Participants who have any form of primary immunodeficiency.
        • Participants who have another primary malignancy within the previous 3 years.
        • Participants who have received or will receive a live or attenuated vaccination within 28 days prior to the start of the NMA-LD.
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

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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

How to Participate

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Locations

Recruiting

United States, California

The Angeles Clinic and Research Institute

The Angels, California, United States, 90025

Recruiting

United States, Florida

Orlando Health Cancer Institute

Orlando, florida, United States, 32610

Recruiting

United States, Florida

Moffitt Cancer Center

Tampa, florida, United States, 33612

Recruiting

United States, Kansas

The University of Kansas Cancer Center

Westwood, Kansas, United States, 66205

Recruiting

United States, Kentucky

University of Louisville

Louisville, Kentucky, United States, 40202

Recruiting

United States, New York

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10065

Recruiting

United States, Ohio

University of Cincinnati

Cincinnati, Ohio, United States, 45219

Recruiting

United States, Wisconsin

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226