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A Study of IOV-4001 for Melanoma or Non-Small Cell Lung Cancer

This study is testing a new treatment called IOV-4001 for adults aged 18 to 70 with unresectable (cannot be removed by surgery) or metastatic (spread to other parts of the body) melanoma, or advanced non-small cell lung cancer (NSCLC). IOV-4001 is made from your own tumor cells, which are specially treated in a lab. You would receive chemotherapy to prepare your body, then an infusion of IOV-4001, followed by another medicine called IL-2. Researchers want to see how safe IOV-4001 is and how well it shrinks tumors. To join, you must have previously received certain therapies, including anti-PD-1/PD-L1 blocking antibodies. The study is currently recruiting participants.

Study design
This is a first-in-human study, planned to enroll 53 participants. It is an interventional study, meaning participants will receive a specific treatment.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for up to 1 year. The study will also track how well the treatment works for up to 60 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05361174

A Study to Investigate the Efficacy and Safety of an Infusion of IOV-4001 in Adult Participants With Unresectable or Metastatic Melanoma or Stage III or IV Non-small-cell Lung Cancer

Recruiting
PHASE1Ages 18–70InterventionalTreatment
Iovance Biotherapeutics, Inc.
~53 participants
Updated 2026-06-11 on ClinicalTrials.gov
What's tested:IOV-4001

At a glance

Recruiting sites
10 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase I: Safety of IOV-4001
Measured over Up to 1 Year or depending on when the recommended phase 2 dose is determined
+1 more outcome measured

Conditions

Unresectable Melanoma
Metastatic Melanoma
Stage III Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer

Explore related trials

Lung Non-Small Cell CarcinomaMelanoma

Where it's being run

11 sites across 8 states
Florida3
New York2
California1
Kansas1
Kentucky1
Ohio1
Pennsylvania1
Wisconsin1

Study leadership

  • Iovance Biotherapeutics Study Team · STUDY_DIRECTOR · Iovance Biotherapeutics

Who to contact

Iovance Biotherapeutics Study Team
[email protected]
1-844-845-4682
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

those without oncogene-driven tumors: Have progressed within 12 weeks after last dose of anti-PD-1/PD-L1 blocking antibody
those with oncogene-driven tumors: Have progressed during/after ≥1 targeted therapy AND either:
platinum doublet chemotherapy
Or within 12 weeks after last dose of anti-PD-1/PD-L1 blocking antibody 3. Participants who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 4. Participants who is assessed as having at least one resectable lesion. 5. Participants who have at least one measurable lesion, following resection of the lesion for IOV-4001 generation. 6. Participants who have adequate organ function. 7. Cardiac function test required. 8. Pulmonary function test may be required. 9. Participants of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control during treatment and up to 12 months. 10. Participants who are \>70 years of age may be allowed to enroll after the investigator discusses with the medical monitor.

What this trial measures

  • Phase I: Safety of IOV-4001Up to 1 Year or depending on when the recommended phase 2 dose is determined

    The safety of IOV-4001 will be assessed based on the totality of dose-limiting toxicity (DLT) and adverse event (AE) data collected during this phase

  • Phase 2: Objective Response Rate (ORR)Up to 60 months

    To evaluate the proportion of participants who have a confirmed complete response (CR) or partial response (PR) per RECIST v1.1 as assessed by the investigator