RECRUITING

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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Conditions

Unresectable MelanomaMetastatic MelanomaStage III Non-small Cell Lung CancerStage IV Non-small Cell Lung CancerTumor Infiltrating LymphocytesTILStage III Non-small-cell lung cancerStage IV Non-small-cell lung cancerPD-1 KnockoutCell TherapyAutologous Adoptive Cell TherapyCellular Immuno-therapyIL-2Non Small Cell Lung CancerNSCLCSecond line Lung CancerBronchial NeoplasmsCarcinomaLung DiseaseMetastatic Lung CancerMetastatic Non Small Cell Lung CancerLung CarcinomaPD-L1Stage IV CancerStage IV Lung CancerStage IV NSCLCSystemic Therapy2nd line therapySecond line therapyCPICheck point inhibitorMetastatic NSCLCNSCLC RecurrentRecurrent Lung CancerRecurrent Lung CarcinomaAutologous Adoptive Cell TransferMelanomaLifileucelStage III MelanomaStage IV MelanomaSkin cancerSkin cancer typesMalignant melanoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood 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).

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

Quick Facts

Study Start:2022-07-20
Study Completion:2027-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05361174

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.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Participants must have a confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma or Stage III or IV NSCLC.
  2. 2. Participants who have received the following previous therapy:
  3. 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.
  4. 2. Cohort 2 (NSCLC): Participants who should have received no more than 3 prior lines of therapy and:
  5. * those without oncogene-driven tumors: Have progressed within 12 weeks after last dose of anti-PD-1/PD-L1 blocking antibody
  6. * those with oncogene-driven tumors: Have progressed during/after ≥1 targeted therapy AND either:
  7. * platinum doublet chemotherapy
  8. * Or within 12 weeks after last dose of anti-PD-1/PD-L1 blocking antibody
  9. 3. Participants who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  10. 4. Participants who is assessed as having at least one resectable lesion.
  11. 5. Participants who have at least one measurable lesion, following resection of the lesion for IOV-4001 generation.
  12. 6. Participants who have adequate organ function.
  13. 7. Cardiac function test required.
  14. 8. Pulmonary function test may be required.
  15. 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.
  16. 10. Participants who are \>70 years of age may be allowed to enroll after the investigator discusses with the medical monitor.
  1. 1. Participants who have melanoma of uveal/ocular origin.
  2. 2. Participants who have symptomatic untreated brain metastases.
  3. 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. 4. Participants who require systemic steroid therapy 10 mg/day prednisone or another steroid equivalent dose.
  5. 5. Participants who have any form of primary immunodeficiency.
  6. 6. Participants who have another primary malignancy within the previous 3 years.
  7. 7. Participants who have received or will receive a live or attenuated vaccination within 28 days prior to the start of the NMA-LD.

Contacts and Locations

Study Contact

Iovance Biotherapeutics Study Team
CONTACT
1-844-845-4682
Clinical.Inquiries@iovance.com

Principal Investigator

Iovance Biotherapeutics Study Team
STUDY_DIRECTOR
Iovance Biotherapeutics

Study Locations (Sites)

The Angeles Clinic and Research Institute
Los Angeles, California, 90025
United States
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
United States
Orlando Health Cancer Institute
Orlando, Florida, 32610
United States
Moffitt Cancer Center
Tampa, Florida, 33612
United States
The University of Kansas Cancer Center
Westwood, Kansas, 66205
United States
University of Louisville
Louisville, Kentucky, 40202
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
University of Cincinnati
Cincinnati, Ohio, 45219
United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Iovance Biotherapeutics, Inc.

  • Iovance Biotherapeutics Study Team, STUDY_DIRECTOR, Iovance Biotherapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-20
Study Completion Date2027-06

Study Record Updates

Study Start Date2022-07-20
Study Completion Date2027-06

Terms related to this study

Keywords Provided by Researchers

  • Tumor Infiltrating Lymphocytes
  • TIL
  • Unresectable Melanoma
  • Metastatic Melanoma
  • Stage III Non-small-cell lung cancer
  • Stage IV Non-small-cell lung cancer
  • PD-1 Knockout
  • Cell Therapy
  • Autologous Adoptive Cell Therapy
  • Cellular Immuno-therapy
  • IL-2
  • Non Small Cell Lung Cancer
  • NSCLC
  • Second line Lung Cancer
  • Bronchial Neoplasms
  • Carcinoma
  • Lung Disease
  • Metastatic Lung Cancer
  • Metastatic Non Small Cell Lung Cancer
  • Lung Carcinoma
  • PD-L1
  • Stage IV Cancer
  • Stage IV Lung Cancer
  • Stage IV NSCLC
  • Systemic Therapy
  • 2nd line therapy
  • Second line therapy
  • CPI
  • Check point inhibitor
  • Metastatic NSCLC
  • NSCLC Recurrent
  • Recurrent Lung Cancer
  • Recurrent Lung Carcinoma
  • Autologous Adoptive Cell Transfer
  • Melanoma
  • Lifileucel
  • Stage III Melanoma
  • Stage IV Melanoma
  • Skin cancer
  • Skin cancer types
  • Malignant melanoma

Additional Relevant MeSH Terms

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