Clinical trial NCT06940739: A Study to Investigate the Safety and Efficacy of IOV-3001 in Adults With Advanced Melanoma Who Will Receive Lifileucel
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Unresectable Melanoma
Metastatic Melanoma
Ocular 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
Lead sponsor: Iovance Biotherapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2025-04-23
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: OTHER

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.

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).

Eligibility 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.

Primary outcomes:
measure: Safety and Tolerability
timeFrame: Up to 30 days
measure: Recommended Dose for Phase 2
timeFrame: Up to 30 days
Secondary outcomes:
measure: Pharmacokinetics (PK) profile of IOV-3001
timeFrame: Up to 8 days
measure: Pharmacokinetic (PK) Profile of IOV-3001
timeFrame: Up to 8 days
measure: Antidrug Antibody (ADA) Profile
timeFrame: Up to 5 years
measure: Overall Response Rate (ORR)
timeFrame: Up to 5 years
measure: Complete Response (CR) rate
timeFrame: Up to 5 years
measure: Duration of Response (DOR)
timeFrame: Up to 5 years
measure: Disease Control Rate (DCR)
timeFrame: Up to 5 years
measure: Progression-Free Survival (PFS)
timeFrame: Up to 5 years
measure: Overall Survival (OS)
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Denver
country: United States
facility: SCRI Oncology Partners- Denver
state: Colorado
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
Study officials:
affiliation: Iovance Biotherapeutics
name: Iovance Biotherapeutics Study Team
role: STUDY_DIRECTOR
References: