New combo therapy aims to supercharge immune cells against tough melanoma
NCT ID NCT06940739
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests a new drug (IOV-3001) designed to boost immune cells in people with advanced melanoma that has not responded to prior treatments. About 42 adults will receive the drug alongside a personalized cell therapy called lifileucel. The main goals are to check safety and find the best dose, while also measuring how the drug behaves in the body and affects the immune system.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 42 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Jul 2032
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
5 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Greenslopes Private Hospital
RECRUITINGGreenslopes, Queensland, 4120, Australia
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Hollywood Private Hospital Ramsay
RECRUITINGNedlands, Western Australia, 6009, Australia
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SCRI Oncology Partners- Denver
RECRUITINGDenver, Colorado, 80218, United States
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Sarah Cannon Research Institute
RECRUITINGNashville, Tennessee, 37203, United States
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UNC Hospitals, The University of North Carolina at Chapel Hill
RECRUITINGChapel Hill, North Carolina, 27514, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Real-World melanoma care under the microscope
- New antibody aims to preserve immune checkpoint while fighting cancer
- Can a DNA vaccine teach the immune system to hunt melanoma?
- Can flooding the liver with chemotherapy stop ocular melanoma?
- Can an immune booster make chemo hit melanoma harder?
- Liver-Targeted immune cell attack tested against melanoma spread