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Clinical Trials in the USA / NCT06940739
Recruiting Phase 1/2

A Study to Investigate the Safety and Efficacy of IOV-3001 in Adults With Advanced Melanoma Who Will Receive Lifileucel

NCT06940739 · tracked via the Priya Life Science USA tracker
Sponsor
Iovance Biotherapeutics, Inc.
Phase
Phase 1/2
Started
2025-03-11
Last updated
2026-06-15

Condition(s) studied

Unresectable MelanomaMetastatic MelanomaOcular Melanoma

Investigational drug(s) / intervention(s)

IOV-3001

IOV-3001: IOV-3001 will be administered as a single dose by IV infusion, which will be administered in a hospital setting.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: 1. Participant must be ≥ 18 years of age at the time of signing the informed consent. 2. Participant has unresectable or metastatic melanoma. 3. 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. 4. Participant has an ECOG performance status of 0 or 1 and, in the investigator's opinion, an estimated life expectancy of \> 6 months. 5. 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. 6. Participant has recovered from all prior anticancer treatment-related AEs Exclusion Criteria: 1. Participant has symptomatic untreated brain metastases. 2. 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. 3. Participant has active uveitis that requires active treatment. 4. Participant has any form of primary immunodeficiency (e.g., severe combined immunodeficiency disease \[SCID\] or AIDS). 5. Participant has a history of hypersensitivity to any component of the study intervention. 6. Participant had another primary malignancy within the previous 3 years. 7. Participants who require systemic steroid therapy 10 mg/day prednisone or another steroid equivalent dose. 8. 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.

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
SCRI Oncology Partners- Denver Denver Colorado Recruiting
UNC Hospitals, The University of North Carolina at Chapel Hill Chapel Hill North Carolina Recruiting
Sarah Cannon Research Institute Nashville Tennessee Recruiting
Greenslopes Private Hospital Greenslopes Queensland Recruiting
Hollywood Private Hospital Ramsay Nedlands Western Australia Recruiting

More Iovance Biotherapeutics, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06940739 on ClinicalTrials.gov ↗ ← All trials in the USA