Testing a New Immune-Boosting Drug (IOV-3001) Combined With Cell Therapy for Advanced Melanoma

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

Iovance Biotherapeutics, Inc.PHASE1 / PHASE2Recruiting
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In Plain English

This is an early-stage study testing a brand-new drug called IOV-3001 in people with advanced melanoma (including eye melanoma) that has spread or can't be surgically removed. The drug is designed to work alongside lifileucel, which is a type of cell therapy that uses your own immune cells to fight cancer. Here's what happens: Doctors will give you IOV-3001 as a single infusion (injection into your vein) in a hospital. The drug is a fusion protein—think of it as two tools stuck together. One part is an antibody (your immune system's natural fighter), and the other part is a modified form of interleukin-2, a substance that supercharges your immune cells to attack cancer more aggressively. Depending on which part of the study you're in, you'll receive IOV-3001 either before or after your lifileucel treatment. Because this is the first time IOV-3001 is being tested in humans, the main goal is to make sure it's safe and to figure out the right dose. Researchers will carefully watch for side effects and measure whether the combination helps shrink tumors. This is early research, so there are unknowns—but if it works, it could offer a new option for people with advanced melanoma.

What This Trial Does

A /2, open-label study of a modified interleukin-2 fusion protein (IOV 3001) in participants with previously treated, or melanoma who will receive lifileucel.

How It Works

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 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).

Who Can Join

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.
Age: 18 Years+

Treatments

IOV-3001 (BIOLOGICAL)

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

Trial Sites (4)

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SCRI Oncology Partners- Denver

Denver, Colorado, United States

Recruiting

UNC Hospitals, The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Recruiting

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Recruiting

Greenslopes Private Hospital

Greenslopes, Queensland, Australia

Recruiting