Recruiting
Phase 1
Phase 2

IOV-4001

Sponsor:

Iovance Biotherapeutics, Inc.

Code:

NCT05361174

Conditions

Unresectable Melanoma

Metastatic Melanoma

Stage III Non-small Cell Lung Cancer

Stage IV Non-small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

IOV-4001

Study Details

Brief summary:

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).

Conditions

Unresectable Melanoma

Metastatic Melanoma

Stage III Non-small Cell Lung Cancer

Stage IV Non-small Cell Lung Cancer

Study ID

NCT05361174

Start date

Jul 20, 2022

Status verified date

Jun, 2026

Completion date

Sep, 2029

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Participants must have a confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma or Stage III or IV NSCLC.
2. Participants who have received the following previous therapy:

1. 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.
2. 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
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.

Exclusion Criteria:

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

Study Design

Enrollment

53 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1

Participants with unresectable or metastatic melanoma

experimental: Cohort 2

Participants with Stage III or IV non-small-cell lung cancer

Interventions

IOV-4001

A tumor sample is resected from each participant and cultured ex-vivo to manufacture IOV-4001. After lymphodepleting chemotherapy including cyclophosphamide and fludarabine, participant is infused with IOV-4001, and followed by IL-2.

Primary outcome measure

  • Phase I: Safety of IOV-4001 [ Time Frame: Up to 1 Year or depending on when the recommended phase 2 dose is determined ]
  • Phase 2: Objective Response Rate (ORR) [ Time Frame: Up to 60 months ]

Central Contacts and Locations

Central contacts

Iovance Biotherapeutics Study Team

1-844-845-4682Clinical.Inquiries@iovance.com

Locations

The Angeles Clinic and Research Institute

Recruiting

Los Angeles, California, United States, 90025

Sylvester Comprehensive Cancer Center

Recruiting

Miami, Florida, United States, 33136

Orlando Health Cancer Institute

Recruiting

Orlando, Florida, United States, 32610

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

The University of Kansas Cancer Center

Recruiting

Westwood, Kansas, United States, 66205

University of Louisville

Recruiting

Louisville, Kentucky, United States, 40202

Weill Medical College of Cornell University

Recruiting

New York, New York, United States, 10022

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45219

UPMC Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

More Information

Sponsor

Iovance Biotherapeutics, Inc.

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Keywords

  • Tumor Infiltrating Lymphocytes
  • TIL
  • Unresectable Melanoma
  • Metastatic Melanoma
  • Stage III Non-small-cell lung cancer
  • Stage IV Non-small-cell lung cancer
  • PD-1 Knockout
  • Cell Therapy
  • Autologous Adoptive Cell Therapy
  • Cellular Immuno-therapy
  • IL-2
  • Non Small Cell Lung Cancer
  • NSCLC
  • Second line Lung Cancer
  • Bronchial Neoplasms
  • Carcinoma
  • Lung Disease
  • Metastatic Lung Cancer
  • Metastatic Non Small Cell Lung Cancer
  • Lung Carcinoma
  • PD-L1
  • Stage IV Cancer
  • Stage IV Lung Cancer
  • Stage IV NSCLC
  • Systemic Therapy
  • 2nd line therapy
  • Second line therapy
  • CPI
  • Check point inhibitor
  • Metastatic NSCLC
  • NSCLC Recurrent
  • Recurrent Lung Cancer
  • Recurrent Lung Carcinoma
  • Autologous Adoptive Cell Transfer
  • Melanoma
  • Lifileucel
  • Stage III Melanoma
  • Stage IV Melanoma
  • Skin cancer
  • Skin cancer types
  • Malignant melanoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Iovance Biotherapeutics, Inc. on 2026-06-11.