Thinking of joining a study?

Register your interest

Become a volunteer?

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

Please Choose a site

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, Tennessee

Sarah Cannon Research Institute

Nashville, Tennessee, United States, 37203