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

NCT06940739 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: IOV-IL2-101
• Study Type: interventional
• Target: 42
• Locations: 2 countries
• Sites: 4

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.

Conditions

Metastatic Melanoma; Ocular Melanoma; Unresectable Melanoma

Keywords

Tumor Infiltrating Lymphocytes; TIL; Unresectable Melanoma; Metastatic Melanoma; Cell Therapy; Autologous Adoptive Cell Therapy; Cellular Immuno-therapy; IL-2; Autologous Adoptive Cell Transfer; Melanoma; Lifileucel; Stage IV Melanoma; Malignant Melanoma; Uveal Melanoma

Outcome Measures

Primary Outcomes (2)

• Safety and Tolerability

  The frequency and severity of treatment emergent adverse events and serious adverse events will be assessed when IOV-3001 administered

  Up to 30 days

• Recommended Dose for Phase 2

  Determine the recommended dose for Phase 2

  Up to 30 days

Secondary Outcomes (10)

• Pharmacokinetics (PK) profile of IOV-3001

  Up to 8 days

• Pharmacodynamic (PD) Profile of IOV-3001

  Up to 8 days

• Antidrug Antibody (ADA) Profile

  Up to 5 years

• Overall Response Rate (ORR)

  Up to 5 years

• Complete Response (CR) rate

  Up to 5 years

Study Arms (1)

Assigned Interventions

EXPERIMENTAL

Dose escalation participants with unresectable or metastatic melanoma

Biological: IOV-3001

Interventions

IOV-3001 BIOLOGICAL

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

Assigned Interventions

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Iovance Biotherapeutics, Inc.: lead

Study Sites (4)

SCRI Oncology Partners- Denver

Denver, Colorado, 80218, United States

RECRUITING

UNC Hospitals, The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

RECRUITING

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

RECRUITING

Greenslopes Private Hospital

Greenslopes, Queensland, 4120, Australia

RECRUITING

MeSH Terms

Conditions

Melanoma; Uveal Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Uveal Neoplasms; Eye Neoplasms; Eye Diseases; Uveal Diseases

Study Officials

• Iovance Biotherapeutics Study Team

  Iovance Biotherapeutics

  STUDY DIRECTOR

Central Study Contacts

Iovance Biotherapeutics

CONTACT

1-844-845-4682; Clinical.Inquiries@iovance.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 23, 2025
• Study Start: March 11, 2025
• Primary Completion (Estimated): June 1, 2032
• Study Completion (Estimated): July 1, 2032
• Last Updated: December 3, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); AU (1)