Actively Recruiting
A Phase 1/2, Open-label Study of PD-1 Knockout Tumor-infiltrating Lymphocytes (IOV-4001) in Participants With Unresectable or Metastatic Melanoma or Stage III or IV Non-small-cell Lung Cancer
Led by Iovance Biotherapeutics, Inc. · Updated on 2024-12-05
53
Participants Needed
10
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of IOV-4001, an infusion treatment made from genetically modified tumor-infiltrating lymphocytes (TILs), in adults with unresectable or metastatic melanoma or advanced non-small-cell lung cancer (NSCLC). This first-in-human study focuses on IOV-4001's potential to enhance antitumor activity by disabling the PD-1 gene, which normally dampens immune response to cancer cells. The study includes participants with advanced stages of melanoma or NSCLC who have previously undergone other therapies. Participants undergo a process where a tumor sample is taken and cultured outside the body to create the IOV-4001 treatment. Before receiving the infusion, they receive chemotherapy to reduce lymphocytes using cyclophosphamide and fludarabine. After the infusion, participants are followed with additional interleukin-2 (IL-2) therapy. The study has two groups: one with melanoma and another with NSCLC, both receiving this experimental treatment without random assignment or blinding. During the study, participants are monitored for safety for up to one year in Phase 1 and for response to treatment over up to 60 months in Phase 2. Researchers assess tumor response, duration of response, disease control, progression-free survival, and overall survival. Organ function, cardiac and pulmonary tests, and treatment tolerance are also evaluated. Participants must adhere to contraceptive guidance during treatment and for 12 months after. The study lasts several years to capture long-term outcomes and safety data.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 70 years
- Confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma or Stage III or IV non-small-cell lung cancer
- Prior therapy including anti-PD-1/PD-L1 blocking antibodies and, for melanoma with BRAF mutations, BRAF/MEK inhibitors
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- At least one resectable lesion available
- At least one measurable lesion after resection for IOV-4001 generation
- Adequate organ function
- Cardiac function test required
- Pulmonary function test may be required
- Willingness to use highly effective birth control during treatment and up to 12 months after
- Participants over 70 may be enrolled after medical discussion
You will not qualify if you...
- Melanoma of uveal or ocular origin
- Untreated symptomatic brain metastases
- History of allogeneic organ transplant or any cell therapy with conditioning chemotherapy within past 20 years
- Need for systemic steroid therapy at doses of 10 mg prednisone or equivalent or higher
- Primary immunodeficiency
- Another primary malignancy within the last 3 years
- Receipt or planned receipt of live or attenuated vaccine within 28 days before starting lymphodepleting chemotherapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year or until the recommended phase 2 dose is determined
Participants undergo lymphodepleting chemotherapy followed by infusion of the IOV-4001 tumor-infiltrating lymphocyte product and subsequent IL-2 treatment.
Multiple visits for infusion and monitoring during treatment
Duration - Up to 60 months
Participants are followed for safety, response, and long-term outcomes after treatment.
Regular visits for assessment of response and safety
Trial Site Locations
Total: 10 locations
1
The Angeles Clinic and Research Institute
Los Angeles, California, United States, 90025
Actively Recruiting
2
Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
3
Orlando Health Cancer Institute
Orlando, Florida, United States, 32610
Actively Recruiting
4
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
5
The University of Kansas Cancer Center
Westwood, Kansas, United States, 66205
Actively Recruiting
6
University of Louisville
Louisville, Kentucky, United States, 40202
Actively Recruiting
7
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
8
University of Cincinnati
Cincinnati, Ohio, United States, 45219
Actively Recruiting
9
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
10
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Withdrawn
Research Team
I
Iovance Biotherapeutics Study Team
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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