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 now · Phase 1/Phase 2

Conditions studied: Unresectable Melanoma, Metastatic Melanoma, Stage III Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

In brief

This is a study to investigate the efficacy and safety of an infusion of IOV-4001 in adult participants with unresectable or metastatic melanoma or advanced non-small-cell lung cancer (NSCLC).

Key facts

Study ID

NCT05361174

Run by

Iovance Biotherapeutics, Inc.

People needed

53

Starts

2022-07-20

Expected to finish

2029-09-01

Last updated by the study team

2026-06-11

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must have a confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma or Stage III or IV NSCLC.
• Participants who have received the following previous therapy:
• Cohort 1 (Melanoma): Participants who have progressed within 12 weeks of last dose of anti-PD-1/PD-L1 blocking antibody and received BRAF/MEK inhibitor in those with BRAF mutations.
• Cohort 2 (NSCLC): Participants who should have received no more than 3 prior lines of therapy and:
• 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
• Participants who have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Participants who is assessed as having at least one resectable lesion.
• Participants who have at least one measurable lesion, following resection of the lesion for IOV-4001 generation.
• Participants who have adequate organ function.
• Cardiac function test required.
• Pulmonary function test may be required.
• 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.
• Participants who are >70 years of age may be allowed to enroll after the investigator discusses with the medical monitor.

You may not qualify if…

• Participants who have melanoma of uveal/ocular origin.
• Participants who have symptomatic untreated brain metastases.
• 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.
• Participants who require systemic steroid therapy 10 mg/day prednisone or another steroid equivalent dose.
• Participants who have any form of primary immunodeficiency.
• Participants who have another primary malignancy within the previous 3 years.
• Participants who have received or will receive a live or attenuated vaccination within 28 days prior to the start of the NMA-LD.

Where it is running

• The Angeles Clinic and Research Institute — Los Angeles, California, United States (enrolling)
• Sylvester Comprehensive Cancer Center — Miami, Florida, United States (enrolling)
• Orlando Health Cancer Institute — Orlando, Florida, United States (enrolling)
• Moffitt Cancer Center — Tampa, Florida, United States (enrolling)
• The University of Kansas Cancer Center — Westwood, Kansas, United States (enrolling)
• University of Louisville — Louisville, Kentucky, United States (enrolling)
• Weill Medical College of Cornell University — New York, New York, United States (enrolling)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (enrolling)
• University of Cincinnati — Cincinnati, Ohio, United States (enrolling)
• UPMC Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (enrolling)
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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