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Recruiting NCT06940739

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

Phase I / Phase II Interventional Unresectable Melanoma Metastatic Melanoma Ocular Melanoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: IOV-3001.
Who it may be relevant to
Registry conditions: Unresectable Melanoma, Metastatic Melanoma, Ocular Melanoma. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Interventions

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

Primary outcome measures

  • Safety and Tolerability [Time frame: Up to 30 days]
  • Recommended Dose for Phase 2 [Time frame: Up to 30 days]
Secondary outcome measures (10)
  • Pharmacokinetics (PK) profile of IOV-3001 [Time frame: Up to 8 days]
  • Pharmacodynamic (PD) Profile of IOV-3001 [Time frame: Up to 8 days]
  • Antidrug Antibody (ADA) Profile [Time frame: Up to 5 years]
  • Overall Response Rate (ORR) [Time frame: Up to 5 years]
  • Complete Response (CR) rate [Time frame: Up to 5 years]
  • Duration of Response (DOR) [Time frame: Up to 5 years]
  • Disease Control Rate (DCR) [Time frame: Up to 5 years]
  • Progression-Free Survival (PFS) [Time frame: Up to 5 years]
  • Overall Survival (OS) [Time frame: Up to 5 years]
  • In vivo persistence of Lifileucel [Time frame: Up to 5 years]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Other

Study locations

United States · 3 centers
  • SCRI Oncology Partners- Denver — Denver
  • UNC Hospitals, The University of North Carolina at Chapel Hill — Chapel Hill
  • Sarah Cannon Research Institute — Nashville
Australia · 2 centers
  • Greenslopes Private Hospital — Greenslopes
  • Hollywood Private Hospital Ramsay — Nedlands

Identifiers

NCT: NCT06940739 · IOV-IL2-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗