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

Description

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).

Conditions

Unresectable Melanoma, Metastatic Melanoma, Stage III Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

Study Overview

Study Details

Study overview

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).

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

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

Condition
Unresectable Melanoma
Intervention / Treatment

-

Contacts and Locations

Los Angeles

The Angeles Clinic and Research Institute, Los Angeles, California, United States, 90025

Miami

Sylvester Comprehensive Cancer Center, Miami, Florida, United States, 33136

Orlando

Orlando Health Cancer Institute, Orlando, Florida, United States, 32610

Tampa

Moffitt Cancer Center, Tampa, Florida, United States, 33612

Westwood

The University of Kansas Cancer Center, Westwood, Kansas, United States, 66205

Louisville

University of Louisville, Louisville, Kentucky, United States, 40202

New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10065

Cincinnati

University of Cincinnati, Cincinnati, Ohio, United States, 45219

Pittsburgh

UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States, 15232

Milwaukee

Medical College of Wisconsin, Milwaukee, Wisconsin, United States, 53226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Participants must have a confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma or Stage III or IV NSCLC.
  • 2. Participants who have received the following previous therapy:
  • 1. 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.
  • 2. 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
  • 3. Participants who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • 4. Participants who is assessed as having at least one resectable lesion.
  • 5. Participants who have at least one measurable lesion, following resection of the lesion for IOV-4001 generation.
  • 6. Participants who have adequate organ function.
  • 7. Cardiac function test required.
  • 8. Pulmonary function test may be required.
  • 9. 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.
  • 10. Participants who are \>70 years of age may be allowed to enroll after the investigator discusses with the medical monitor.
  • 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 of cell therapy involving prior conditioning chemotherapy within the past 20 years.
  • 4. Participants who require systemic steroid therapy 10 mg/day prednisone or another steroid 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 vaccination within 28 days prior to the start of the NMA-LD.

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Iovance Biotherapeutics, Inc.,

Iovance Biotherapeutics Study Team, STUDY_DIRECTOR, Iovance Biotherapeutics

Study Record Dates

2027-06