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

NCT05361174 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: IOV-GM1-201
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 11

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

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

Outcome Measures

Primary Outcomes (2)

• Phase I: Safety of IOV-4001

  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

  Up to 1 Year or depending on when the recommended phase 2 dose is determined

• Phase 2: Objective Response Rate (ORR)

  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

  Up to 60 months

Secondary Outcomes (7)

• CR Rate

  Up to 60 months

• Duration of Response (DOR)

  Up to 60 months

• Disease Control Rate (DCR)

  Up to 60 months

• Progression-free Survival (PFS)

  Up to 60 months

• Overall Survival (OS)

  Up to 60 months

Study Arms (2)

Cohort 1

EXPERIMENTAL

Participants with unresectable or metastatic melanoma

Biological: IOV-4001

Cohort 2

EXPERIMENTAL

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

Biological: IOV-4001

Interventions

IOV-4001 BIOLOGICAL

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.

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

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.

Sponsors & Collaborators

• Iovance Biotherapeutics, Inc.: lead

Study Sites (11)

The Angeles Clinic and Research Institute

Los Angeles, California, 90025, United States

RECRUITING

Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

RECRUITING

Orlando Health Cancer Institute

Orlando, Florida, 32610, United States

RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

The University of Kansas Cancer Center

Westwood, Kansas, 66205, United States

RECRUITING

University of Louisville

Louisville, Kentucky, 40202, United States

RECRUITING

Weill Medical College of Cornell University

New York, New York, 10022, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

University of Cincinnati

Cincinnati, Ohio, 45219, United States

RECRUITING

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

WITHDRAWN

MeSH Terms

Conditions

Melanoma; Carcinoma, Non-Small-Cell Lung; Bronchial Neoplasms; Carcinoma; Lung Diseases; Lung Neoplasms; Neoplasms; Skin Neoplasms

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Respiratory Tract Neoplasms; Thoracic Neoplasms; Respiratory Tract Diseases; Bronchial Diseases; Neoplasms, Glandular and Epithelial

Study Officials

• Iovance Biotherapeutics Study Team

  Iovance Biotherapeutics

  STUDY DIRECTOR

Central Study Contacts

Iovance Biotherapeutics Study Team

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: May 4, 2022
• Study Start: July 20, 2022
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2029
• Last Updated: June 11, 2026

Record last verified: 2026-06

Locations

US (11)