RecruitingPhase 1Phase 2NCT05361174

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

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


Sponsor

Iovance Biotherapeutics, Inc.

Enrollment

53 participants

Start Date

Jul 20, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an experimental infusion therapy (IOV-4001) in adults with advanced melanoma or advanced non-small cell lung cancer (NSCLC) that has not responded to standard immunotherapy treatments. **You may be eligible if...** - You have been diagnosed with advanced or metastatic melanoma (stage IIIC, IIID, or IV), OR stage III–IV non-small cell lung cancer - For melanoma: your cancer progressed within 12 weeks of receiving an anti-PD-1/PD-L1 drug, and if your tumor has a BRAF mutation, you also tried a BRAF/MEK inhibitor - For NSCLC: you have received no more than 3 prior treatment lines - You are an adult **You may NOT be eligible if...** - You have active, untreated cancer in the brain - You have serious autoimmune conditions - You have significant heart, liver, or kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALIOV-4001

A tumor sample is resected from each participant and cultured ex-vivo to manufacture IOV-4001. After lymphodepleting chemotherapy including cyclophosphamide and fludarabine, participant is infused with IOV-4001, and followed by IL-2.


Locations(10)

The Angeles Clinic and Research Institute

Los Angeles, California, United States

Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Orlando Health Cancer Institute

Orlando, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

The University of Kansas Cancer Center

Westwood, Kansas, United States

University of Louisville

Louisville, Kentucky, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

University of Cincinnati

Cincinnati, Ohio, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05361174


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