IOV-3001: IOV-3001 will be administered as a single dose by IV infusion, which will be administered in a hospital setting.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
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 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 outcome measure(s)
Safety and Tolerability — Up to 30 days The frequency and severity of treatment emergent adverse events and serious adverse events will be assessed when IOV-3001 administered
Recommended Dose for Phase 2 — Up to 30 days Determine the recommended dose for Phase 2
Trial sites (5)
Facility
City
Region
Status
SCRI Oncology Partners- Denver
Denver
Colorado
Recruiting
UNC Hospitals, The University of North Carolina at Chapel Hill
Chapel Hill
North Carolina
Recruiting
Sarah Cannon Research Institute
Nashville
Tennessee
Recruiting
Greenslopes Private Hospital
Greenslopes
Queensland
Recruiting
Hollywood Private Hospital Ramsay
Nedlands
Western Australia
Recruiting
More Iovance Biotherapeutics, Inc. trials in the USA
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.