No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 70
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Other
Participants needed
42 (estimated)
Sponsor
Iovance Biotherapeutics, Inc. · Industry
Who this trial is looking for
This trial is looking for adults with advanced melanoma who have not responded to previous treatments. Participants will receive the drug IOV-3001 along with another treatment called lifileucel.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years or older.
I have unresectable or metastatic melanoma.
I have melanoma that is not from the eye and my disease has progressed after previous treatment with PD-1/PD-L1 blockers.
If I have uveal melanoma, I have received tebentafusp if it was available to me.
I have an ECOG performance status of 0 or 1 and my doctor believes I have more than 6 months to live.
After having surgery for lifileucel, I have at least one measurable tumor.
I have recovered from all side effects of previous cancer treatments.
You may not be able to join if
I have untreated brain metastases.
I am at high risk for infections or have serious health issues.
I have active eye inflammation that needs treatment.
I have a primary immunodeficiency.
I have an allergy to any part of this study treatment.
I was diagnosed with another type of cancer in the last 3 years.
I need steroid medication of 10 mg/day or more.
I have had an organ transplant or cellular therapy in the last 20 years.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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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 therap…
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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