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NCT06940739 | RECRUITING | Unresectable Melanoma

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

Iovance Biotherapeutics, Inc.

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.

Condition or disease

Unresectable Melanoma

Metastatic Melanoma

Ocular Melanoma

Intervention/treatment

IOV-3001

Phase

PHASE1

PHASE2

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).

Study Type : INTERVENTIONAL
Estimated Enrollment : 42 participants
Masking : NONE
Primary Purpose : OTHER
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
Actual Study Start Date : 2025-03-11
Estimated Primary Completion Date : 2032-06
Estimated Study Completion Date : 2032-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
A Study to Investigate the Safety and Efficacy of IOV-3001 in Adults With Advanced Melanoma Who Will Receive Lifileucel

Location Details

NCT06940739

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Colorado

SCRI Oncology Partners- Denver

Denver, Colorado, United States, 80218

RECRUITING

United States, North Carolina

UNC Hospitals, The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27514

RECRUITING

United States, Tennessee

Sarah Cannon Research Institute

Nashville, Tennessee, United States, 37203

RECRUITING

Australia, Queensland

Greenslopes Private Hospital

Greenslopes, Queensland, Australia, 4120