IOV-4001 in Melanoma or Non-Small-Cell Lung Cancer

What is the Purpose of this Study?

The purpose of this study is to determine whether an investigational drug called IOV-4001 is safe and beneficial in the treatment of patients with unresectable or metastatic melanoma or advanced non-small cell lung cancer (NSCLC). IOV-4001 is an adoptive T cell therapy, a form of immunotherapy that uses the patient’s own T cells (tumor infiltrating lymphocytes-TILs), to focus the immune system to fight cancer. The treatment consists of specialized white blood cells (TILs) obtained from a piece of the patient’s tumor. Participants will undergo a tumor resection (surgery that removes a piece of the tumor to obtain TILs). This will be sent to a manufacturing facility where the patient’s T cells are isolated and grown to create IOV-4001. IOV-4001 will then be infused into the patient’s body, where the T cells may detect and attack the tumor. The therapy consists of a preconditioning regimen of chemotherapy medications (cyclophosphamide and fludarabine), which is given before the infusion of IOV-4001. After receiving the infusion, the patients will receive a medication called interleukin-2, which is a naturally occurring protein that helps regulate white blood cell activities and their immune response. Sponsor: Iovance Tumor Types: Melanoma, Non-small cell lung cancer

Eligibility

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.

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.

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Where can I participate?

CS Cancer at Cedars-Sinai Medical Center : Saba Mukarram
CS Cancer at The Angeles Clinic and Research Institute : Saba Mukarram

More about this Clinical Trial

What is the full name of this clinical trial?

IOV-GM1-201: A Phase 1/2, open-label study of PD-1 knockout tumor-infiltrating lymphocytes in participants with unresectable or metastatic melanoma or Stage III or IV non-small-cell lung cancer

Study Details

Disease Type/Condition

Lung Cancer, Non-small cell

Principal Investigator

Hamid, Omid

Co-Investigators

Ani Balmanoukian, Cathie T Chung, Inderjit Mehmi, Iryna Singh, Justin Moyers, Kristopher Wentzel, Mark Faries, Navid Hafez, Vi K. Chiu

Age Group

Adult

Phase

I/II

IRB Number

STUDY00002350

ClinicalTrials.gov ID

NCT05361174

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

Name

Saba Mukarram

Phone

+1 310-231-2181

MukarramS@cshs.org