A Phase 1/2, multicenter, multi-cohort, open-label study of an autologous tumor-infiltrating lymphocytes (TIL) regimen with IOV-5001 in participants with previously treated advanced solid tumors
Participant must be ≥ 18 years of age at the time of signing the informed consent.
Radiographic disease progression: Participant has radiographic disease progression after the most recent line of therapy.
After having received platinum-based chemotherapy and an immune checkpoint inhibitor, either administered concurrently or sequentially for Stage IV disease.
Within 6 months of completion of the platinum component of platinum-based chemotherapy in the adjuvant or neoadjuvant setting and having progressed after receiving an immune checkpoint inhibitor in the neoadjuvant, adjuvant, or metastatic setting.
Participants with symptomatic untreated brain metastases. Participants with brain metastases may be enrolled with considerations and discussion with medical monitor.
Participant has an active medical illness(es) that, in the opinion of the investigator would pose increased risks for study participation. Participant has evidence of any active viral, bacterial, or fungal infection requiring ongoing systemic treatment or identified during screening.
Participant has any form of primary immunodeficiency (eg, severe combined immunodeficiency disease [SCID] or AIDS).
Participant has a history of hypersensitivity to any component of the study intervention.
Sequential
IOV-5001
Biological/VaccineIOV-5001 will be administered as 2 infusions, which will be administered in a hospital setting.
Phase 1: Safety Assessment
The safety of IOV-5001 will be assessed based on the totality of DLT and AE data collected during this phase.
Phase 2: Efficacy Measured by Overall Response Rate (ORR)
To evaluate the efficacy of IOV-5001 in select solid tumor indications as measured by ORR per RECIST v1.1 as assessed by the investigator.
Complete Response (CR) Rate
CR rate is defined as the proportion of participants who have a confirmed CR per RECIST v1.1 from the date of the IOV-5001 infusion until disease progression, the start of a new anticancer therapy, or death due to any cause, whichever occurs first (up to a maximum of 5 calendar years after the IOV-5001 infusion).
Duration of Response (DOR)
DOR is measured from the time that criteria are met for CR or PR per RECIST v1.1 until disease progression or death due to any cause (up to a maximum of 5 calendar years after the IOV-5001 infusion).
Disease Control Rate (DCR)
DCR is measured by the percentage of participants with a best overall confirmed response of CR or PR at any time or SD ≥ 4 weeks per RECIST v1.1 from the date of the IOV-5001 infusion until disease progression, the start of a new anticancer therapy, or death due to any cause, whichever occurs first (up to a maximum of 5 calendar years after the IOV-5001 infusion).
Progression-Free Survival (PFS)
PFS is defined as the time from the date of lifileucel infusion until disease progression per RECIST v1.1 as assessed by investigator or death due to any cause (up to a maximum of 5 years after the lifileucel infusion)
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