Unresectable MelanomaPhase 1/2NCT06940739
A Study to Investigate the Safety and Efficacy of IOV-3001 in Adults With Advanced Melanoma Who Will Receive Lifileucel
A Phase 1/2 study testing IOV-3001 in people with Unresectable Melanoma and Metastatic Melanoma, run by Iovance Biotherapeutics, Inc. at 5 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Unresectable Melanoma, Metastatic Melanoma, Ocular Melanoma
- What is being tested?
- IOV-3001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 11 Mar 2025to Jul 2032
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must be ≥ 18 years of age at the time of signing the informed consent.
- Participant has unresectable or metastatic melanoma.
- 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]-A02:01 positive participant and approved by local authorities for uveal melanoma) or refused.
- Participant has an ECOG performance status of 0 or 1 and, in the investigator's opinion, an estimated life expectancy of > 6 months.
- 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.
- Participant has recovered from all prior anticancer treatment-related AEs
Who cannot join
- Participant has symptomatic untreated brain metastases.
- 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.
- Participant has active uveitis that requires active treatment.
- Participant has any form of primary immunodeficiency (e.g., severe combined immunodeficiency disease [SCID] or AIDS).
- Participant has a history of hypersensitivity to any component of the study intervention.
- Participant had another primary malignancy within the previous 3 years.
- Participants who require systemic steroid therapy 10 mg/day prednisone or another steroid equivalent dose.
- 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.
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
United States3 sites, 3 recruiting
- Recruiting
UNC Hospitals, The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
- Recruiting
SCRI Oncology Partners- Denver
Denver, Colorado, 80218
- Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Australia2 sites, 2 recruiting
- Recruiting
Greenslopes Private Hospital
Greenslopes, Queensland, 4120
- Recruiting
Hollywood Private Hospital Ramsay
Nedlands, Western Australia, 6009
About this study
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
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.
Read the 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).
- Conditions
- Unresectable Melanoma, Metastatic Melanoma, Ocular Melanoma
- Being tested
- IOV-3001
- 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
- Medical subject headings
- Melanoma, Uveal Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IOV-3001Biological
IOV-3001 will be administered as a single dose by IV infusion, which will be administered in a hospital setting.
| Study group | Role | What they receive |
|---|---|---|
| Assigned Interventions | Experimental | Dose escalation participants with unresectable or metastatic melanoma Receives: Biological: IOV-3001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
The frequency and severity of treatment emergent adverse events and serious adverse events will be assessed when IOV-3001 administered
Measured: Up to 30 days
Recommended Dose for Phase 2
Determine the recommended dose for Phase 2
Measured: Up to 30 days
Secondary outcomes (10)
Pharmacokinetics (PK) profile of IOV-3001
PK as measured by maximum observed drug concentration in plasma (Cmax) after single dose, and area under the concentration vs. time curve (AUC) after single dose.
Measured: Up to 8 days
Pharmacodynamic (PD) Profile of IOV-3001
The PD profile will be assessed by evaluating changes in the expression of phenotypic markers, serum cytokines and chemokines in blood.
Measured: Up to 8 days
Antidrug Antibody (ADA) Profile
ADAs to IOV-3001 will be measured in blood.
Measured: Up to 5 years
Overall Response Rate (ORR)
ORR is defined as the proportion of participants who have a confirmed CR or PR per RECIST v1.1 as assessed by the investigator from the date of lifileucel infusion until disease progression, start of a new anticancer therapy, or death due to any cause cause, whichever occurs first (up to a maximum of 5 years after the lifileucel infusion)
Measured: Up to 5 years
Complete Response (CR) rate
CR rate is defined as the proportion of participants who have a confirmed CR per RECIST v1.1 as assessed by the investigator from the date of lifileucel infusion until disease progression, start of a new anticancer therapy, or death due to any cause cause (up to a maximum of 5 years after the lifileucel infusion)
Measured: Up to 5 years
Duration of Response (DOR)
DOR is measured from the time that criteria are met for CR or PR per RECIST v1.1 as assessed by the investigator disease progression or death due to any cause (up to a maximum of 5 years after the lifileucel infusion)
Measured: Up to 5 years
Disease Control Rate (DCR)
DCR is measured by the percentage of participants with a best overall confirmed response of CR or PR at any time participants with SD ≥ 4 weeks per RECIST v1.1 as assessed by the investigator from the date of lifileucel infusion disease progression, start of a new anticancer therapy, or death due to any cause (up to a maximum of 5 years after the lifileucel infusion)
Measured: Up to 5 years
Progression-Free Survival (PFS)
PFS is defined as the time from the date of lifileucel infusion until disease progression per RECIST v1.1 as assessed by investigator or death due to any cause (up to a maximum of 5 years after the lifileucel infusion)
Measured: Up to 5 years
Overall Survival (OS)
OS is the time from the date of lifileucel infusion to death due to any cause (up to a maximum of 5 years after the lifileucel infusion)
Measured: Up to 5 years
In vivo persistence of Lifileucel
In vivo persistence of lifileucel products will be assessed in the blood.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start11 Mar 2025
- Primary completionJun 2032 (estimated)
- Study completionJul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iovance Biotherapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Iovance Biotherapeutics Study Team, Study director, Iovance Biotherapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06940739
- Sponsor's protocol ID
- IOV-IL2-101
- Status last verified
- Jun 2026
- First submitted
- 8 Apr 2025
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06940739
- Acronym / sponsor ID
- IOV-IL2-101
- 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
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Iovance Biotherapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- Jun 2032 (estimated)
- Study completion
- Jul 2032 (estimated)
- First posted
- 23 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assigned Interventions | Experimental | Biological: IOV-3001Dose escalation participants with unresectable or metastatic melanoma |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participant must be ≥ 18 years of age at the time of signing the informed consent.
- Participant has unresectable or metastatic melanoma.
- 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]-A02:01 positive participant and approved by local authorities for uveal melanoma) or refused.
- Participant has an ECOG performance status of 0 or 1 and, in the investigator's opinion, an estimated life expectancy of > 6 months.
Key exclusion criteria (8 listed)
- Participant has symptomatic untreated brain metastases.
- 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.
- Participant has active uveitis that requires active treatment.
- Participant has any form of primary immunodeficiency (e.g., severe combined immunodeficiency disease [SCID] or AIDS).
- Participant has a history of hypersensitivity to any component of the study intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IOV-3001IOV-3001 will be administered as a single dose by IV infusion, which will be administered in a hospital setting. | Biological | Assigned Interventions |
Primary outcome
Safety and Tolerability
Time frame: 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
Time frame: Up to 30 days
Determine the recommended dose for Phase 2
10 secondary outcomes
Pharmacokinetics (PK) profile of IOV-3001
Time frame: Up to 8 days
Pharmacodynamic (PD) Profile of IOV-3001
Time frame: Up to 8 days
Antidrug Antibody (ADA) Profile
Time frame: Up to 5 years
Overall Response Rate (ORR)
Time frame: Up to 5 years
Complete Response (CR) rate
Time frame: Up to 5 years
Duration of Response (DOR)
Time frame: Up to 5 years
Disease Control Rate (DCR)
Time frame: Up to 5 years
Progression-Free Survival (PFS)
Time frame: Up to 5 years
Overall Survival (OS)
Time frame: Up to 5 years
In vivo persistence of Lifileucel
Time frame: Up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Iovance Biotherapeutics Study Team study director
Iovance Biotherapeutics
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IOV-3001 in people with Unresectable Melanoma and Metastatic Melanoma, run by Iovance Biotherapeutics, Inc. at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Iovance Biotherapeutics (1-844-845-4682, Clinical.Inquiries@iovance.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (time frame: Up to 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.