A Study to Investigate the Safety and Efficacy of IOV-3001 in Adults With Advanced Melanoma Who Will Receive Lifileucel
- Conditions
- Unresectable MelanomaMetastatic MelanomaOcular Melanoma
- Interventions
- Registration Number
- NCT06940739
- Lead Sponsor
- Iovance Biotherapeutics, Inc.
- Brief Summary
A Phase 1/2, open-label study of a modified interleukin-2 fusion protein (IOV 3001) in participants with previously treated, unresectable or metastatic melanoma who will receive lifileucel.
- Detailed Description
This study is the first-in-human (FIH) study of IOV-3001. IOV-3001 is an antibody interleukin-2 (IL-2) fusion protein in which a modified form of aldesleukin is incorporated into the antibody palivizumab.
The Phase 1 portion will include 2 parts. Participants will receive IOV-3001 either before the Lifileucel regimen (Part 1) or after Lifileucel instead of aldesleukin (Part 2).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 42
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Participant must be ≥ 18 years of age at the time of signing the informed consent.
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Participant has unresectable or metastatic melanoma.
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Participant has melanoma not of uveal/ocular origin and experienced documented radiographic disease progression during systemic therapy with a PD-1/PD-L1 blocking antibody or within 12 weeks after the last dose of the PD-1/PD-L1 blocking antibody. If the tumor is BRAF V600 mutation positive, the participant also received or refused a BRAF inhibitor with or without a MEK inhibitor.
OR Phase 1, Part 1 only: For participants with uveal melanoma, tebentafusp must have been received if available as standard of care (human leukocyte antigen [HLA]-A*02:01 positive participant and approved by local authorities for uveal melanoma) or refused.
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Participant has an ECOG performance status of 0 or 1 and, in the investigator's opinion, an estimated life expectancy of > 6 months.
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Phase 1, Part 2 only: Following tumor resection for lifileucel generation, the participant will have at least one remaining measurable lesion, as defined by RECIST v1.1.
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Participant has recovered from all prior anticancer treatment-related AEs
- Participant has symptomatic untreated brain metastases.
- Participant is at an increased risk for systemic infections; seizure disorders; coagulation disorders; or other active major medical illnesses of the cardiovascular, respiratory, or immune systems.
- Participant has active uveitis that requires active treatment.
- Participant has any form of primary immunodeficiency (e.g., severe combined immunodeficiency disease [SCID] or AIDS).
- Participant has a history of hypersensitivity to any component of the study intervention.
- Participant had another primary malignancy within the previous 3 years.
- Participants who require systemic steroid therapy 10 mg/day prednisone or another steroid equivalent dose.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Assigned Interventions IOV-3001 Dose escalation participants with unresectable or metastatic melanoma
- Primary Outcome Measures
Name Time Method Safety and Tolerability Up to 30 days The frequency and severity of treatment emergent adverse events and serious adverse events will be assessed when IOV-3001 administered
Recommended Dose for Phase 2 Up to 30 days Determine the recommended dose for Phase 2
- Secondary Outcome Measures
Name Time Method Pharmacokinetics (PK) profile of IOV-3001 Up to 8 days PK as measured by maximum observed drug concentration in plasma (Cmax) after single dose
Pharmacokinetic (PK) Profile of IOV-3001 Up to 8 days Area under the concentration vs. time curve (AUC) after single dose
Antidrug Antibody (ADA) Profile Up to 5 years ADAs to IOV-3001 will be measured
Overall Survival (OS) Up to 5 years OS is the time from the date of lifileucel infusion to death due to any cause (up to a maximum of 5 years after the lifileucel infusion)
Overall Response Rate (ORR) Up to 5 years ORR is defined as the proportion of participants who have a confirmed CR or PR per RECIST v1.1 as assessed by the investigator from the date of lifileucel infusion until disease progression, start of a new anticancer therapy, or death due to any cause cause, whichever occurs first (up to a maximum of 5 years after the lifileucel infusion)
Complete Response (CR) rate Up to 5 years CR rate is defined as the proportion of participants who have a confirmed CR per RECIST v1.1 as assessed by the investigator from the date of lifileucel infusion until disease progression, start of a new anticancer therapy, or death due to any cause cause (up to a maximum of 5 years after the lifileucel infusion)
Duration of Response (DOR) Up to 5 years DOR is measured from the time that criteria are met for CR or PR per RECIST v1.1 as assessed by the investigator disease progression or death due to any cause (up to a maximum of 5 years after the lifileucel infusion)
Disease Control Rate (DCR) Up to 5 years DCR is measured by the percentage of participants with a best overall confirmed response of CR or PR at any time participants with SD ≥ 4 weeks per RECIST v1.1 as assessed by the investigator from the date of lifileucel infusion disease progression, start of a new anticancer therapy, or death due to any cause (up to a maximum of 5 years after the lifileucel infusion)
Progression-Free Survival (PFS) Up to 5 years 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)
Trial Locations
- Locations (1)
Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States