NCT06940739 A Study to Investigate the Safety and Efficacy of IOV-3001 in Adults With Advanced Melanoma Who Will Receive Lifileucel
| NCT ID | NCT06940739 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Iovance Biotherapeutics, Inc. |
| Condition | Unresectable Melanoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 42 participants |
| Start Date | 2025-03-11 |
| Primary Completion | 2032-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 42 participants in total. It began in 2025-03-11 with a primary completion date of 2032-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Iovance Biotherapeutics Study Team
STUDY DIRECTOR
Iovance Biotherapeutics
Frequently Asked Questions
Who can join the NCT06940739 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Unresectable Melanoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06940739 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06940739 currently recruiting?
Yes, NCT06940739 is actively recruiting participants. Contact the research team at Clinical.Inquiries@iovance.com for enrollment information.
Where is the NCT06940739 trial being conducted?
This trial is being conducted at Denver, United States, Chapel Hill, United States, Nashville, United States, Greenslopes, Australia.
Who is sponsoring the NCT06940739 clinical trial?
NCT06940739 is sponsored by Iovance Biotherapeutics, Inc.. The principal investigator is Iovance Biotherapeutics Study Team at Iovance Biotherapeutics. The trial plans to enroll 42 participants.
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