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.
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.
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
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- BiologicalIOV-3001
IOV-3001 will be administered as a single dose by IV infusion, which will be administered in a hospital setting.
Locations (4)
- SCRI Oncology Partners- DenverDenver, Colorado
- UNC Hospitals, The University of North Carolina at Chapel HillChapel Hill, North Carolina
- Sarah Cannon Research InstituteNashville, Tennessee
- Greenslopes Private HospitalGreenslopes, Queensland