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).
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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
53
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.
The Angeles Clinic and Research Institute
Los Angeles, California, United States
RECRUITINGSylvester Comprehensive Cancer Center
Miami, Florida, United States
RECRUITINGOrlando Health Cancer Institute
Orlando, Florida, United States
RECRUITINGMoffitt Cancer Center
Tampa, Florida, United States
RECRUITINGThe University of Kansas Cancer Center
Westwood, Kansas, United States
RECRUITINGUniversity of Louisville
Louisville, Kentucky, United States
RECRUITINGMemorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITINGUniversity of Cincinnati
Cincinnati, Ohio, United States
RECRUITINGUPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
RECRUITINGMedical College of Wisconsin
Milwaukee, Wisconsin, United States
WITHDRAWNPhase I: Safety of IOV-4001
The safety of IOV-4001 will be assessed based on the totality of dose-limiting toxicity (DLT) and adverse event (AE) data collected during this phase
Time frame: Up to 1 Year or depending on when the recommended phase 2 dose is determined
Phase 2: Objective Response Rate (ORR)
To evaluate the proportion of participants who have a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 as assessed by the investigator
Time frame: Up to 60 months
CR Rate
To evaluate the proportion of participants who have a confirmed CR per RECIST v1.1 as assessed by the investigator
Time frame: Up to 60 months
Duration of Response (DOR)
To evaluate the duration from the time that criteria are met for CR or PR per RECIST v1.1 as assessed by the investigator until disease progression or death due to any cause
Time frame: Up to 60 months
Disease Control Rate (DCR)
To evaluate the percentage of participants with a best overall confirmed response of CR or PR at any time plus stable disease (SD) per RECIST v1.1 as assessed by the investigator
Time frame: Up to 60 months
Progression-free Survival (PFS)
To evaluate the time from the date of IOV-4001 infusion until disease progression per RECIST v1.1 as assessed by the investigator or death due to any cause
Time frame: Up to 60 months
Overall Survival (OS)
To evaluate the time from the date of IOV-4001 infusion to death due to any cause.
Time frame: Up to 60 months
Safety and Tolerability of IOV-4001
This will be characterized by the severity, seriousness, relationship to study treatment, and characteristics of treatment-emergent adverse events (TEAEs).
Time frame: Up to 60 months
Feasibility of IOV-4001
This will be assessed by the proportion of participants who had tumor harvested and were treated without manufacturing delay or failure.
Time frame: Up to 60 months
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