Status:
RECRUITING
A Study to Investigate the Safety and Efficacy of IOV-3001 in Adults With Advanced Melanoma Who Will Receive Lifileucel
Lead Sponsor:
Iovance Biotherapeutics, Inc.
Conditions:
Unresectable Melanoma
Metastatic Melanoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
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 palivizu...
Eligibility Criteria
Inclusion
- Participant must be ≥ 18 years of age at the time of signing the informed consent.
- Participant has unresectable or metastatic melanoma.
- 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.
- Participant has an ECOG performance status of 0 or 1 and, in the investigator's opinion, an estimated life expectancy of \> 6 months.
- 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.
- Participant has recovered from all prior anticancer treatment-related AEs
Exclusion
- 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.
Key Trial Info
Start Date :
March 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2032
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT06940739
Start Date
March 11 2025
End Date
July 1 2032
Last Update
December 3 2025
Active Locations (4)
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1
SCRI Oncology Partners- Denver
Denver, Colorado, United States, 80218
2
UNC Hospitals, The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514
3
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
4
Greenslopes Private Hospital
Greenslopes, Queensland, Australia, 4120