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Layout table for study information Study Type : Interventional (Clinical Trial) ActualEnrollment : 178 participants Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: A Phase 2, Multicenter Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-144) for Treatment of Patients With Metastatic Melanoma Study Start Date : September 2015 Estimated Primary Completion Date : July 2021 Estimated Study Completion Date : December 2024 Resource links provided by the National Library of Medicine MedlinePlus Genetics related topics: Melanoma MedlinePlus related topics: Melanoma Genetic and Rare Diseases Information Center resources: Neuroendocrine Tumor Neuroepithelioma U.S. FDA Resources Arms and Interventions Go to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Arm Intervention/treatment Experimental: Cohort 1Lifileucel (LN-144) without cryopreservation (Gen 1 infusion product) (Closed) Biological: LifileucelA tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with Lifileucel followed by IL-2.Other Name: LN - 144 Experimental: Cohort 2Cryopreserved lifileucel (LN-144) (Gen 2 infusion product) (Closed) Biological: LifileucelA tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with Lifileucel followed by IL-2.Other Name: LN - 144 Experimental: Cohort 3Retreatment cohort: patients from Cohort 1, Cohort 2 or Cohort 4 may rescreen for a second TIL regimen therapy if they meet all Inclusion and Exclusion Criteria (except exclusion criterion b). Biological: LifileucelA tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with Lifileucel followed by IL-2.Other Name: LN - 144 Experimental: Cohort 4Cryopreserved lifileucel (LN-144) (Gen 2 infusion product) Biological: LifileucelA tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with Lifileucel followed by IL-2.Other Name: LN - 144 Outcome Measures Go to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Primary Outcome Measures : Disease Assessment for Objective Response Rate [ Time Frame: Every 6 weeks for 6 months, then every 3 months for a maximum of 54 months ]Evaluate the efficacy of LN-144 in patients with unresectable or metastatic melanoma using the objective response rate (ORR), as assessed by the Blinded Independent Review Committee (BIRC) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 Secondary Outcome Measures : Disease Assessment for Duration of Response [ Time Frame: Every 6 weeks for 6 months, then every 3 months for a maximum of 54 months ]Evaluate the efficacy endpoints of duration of response (DOR) by the BIRC and by the investigator per RECIST v1.1 Disease Assessment for Disease Control Rate [ Time Frame: Every 6 weeks for 6 months, then every 3 months for a maximum of 54 months ]Evaluate the efficacy endpoints of disease control rate (DCR) as assessed by the BIRC and by the investigator per RECIST v1.1 Disease Assessment for Progression-Free Survival [ Time Frame: Every 6 weeks for 6 months, then every 3 months for a maximum of 54 months ]Evaluate the efficacy endpoints of progression-free survival (PFS) as assessed by the BIRC and by the investigator per RECIST v1.1 Overall Survival [ Time Frame: Until death or up to 60 months ]Evaluate overall survival (OS) and objective response rate (ORR) by the investigator Adverse Events [ Time Frame: Maximum 60 months ]Incidence rate of treatment-emergent adverse events (AEs) and serious AEs by severity and relationship to Lifileucel (LN-144). Eligibility CriteriaGo to Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. Layout table for eligibility information Ages Eligible for Study: 18 Years and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Patients must meet all of the following inclusion criteria to be eligible for participation in the study:

IOV-COM-202 is a Phase 2 clinical trial of Iovance TIL therapy (lifileucel, LN-145, LN-144 and LN-145-S1). It is enrolling patients who have been diagnosed with histologically confirmed unresectable or metastatic melanoma, recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), recurrent or metastatic non-small cell lung cancer (NSCLC) or relapsed or refractory NSCLC.

Lung cancer is responsible for approximately two million deaths worldwide each year,1 including nearly 132,000 deaths in the US alone.2 The disease can affect anyone, and many people diagnosed today have either stopped smoking years earlier or never smoked. The main types of lung cancer are small cell lung cancer (SCLC) and NSCLC, and they are treated differently. NSCLC begins in the epithelial cells of the lungs. SCLC begins in the nerve cells or hormone-producing cells of the lung.

The main types of cervical cancer are squamous cell carcinoma and adenocarcinoma. Squamous cell carcinoma begins in the thin, flat cells that line the cervix. Adenocarcinoma begins in cervical cells that make mucus and other fluids. Despite the availability of the human papilloma virus (HPV) vaccine, nearly 19,000 new cases of cervical cancer are diagnosed in the US each year and are responsible for approximately 8,000 deaths.1

C-145-04 is a Phase 2 clinical trial enrolling patients with recurrent, metastatic or persistent cervical cancer. The clinical trial was designed to determine whether Iovance investigational TIL therapy lifileucel is safe and effective for the treatment of recurrent, metastatic or persistent cervical carcinoma.

IOV-GM1-201 is Phase 1/2 study to evaluate the safety and efficacy of IOV-4001, a genetically modified autologous PD-1 knockout tumor-infiltrating lymphocytes (TIL) product, in patients with unresectable or metastatic melanoma, or stage III or IV non-small-cell lung cancer.

CLL and SLL are two types of blood cancer that primarily impact older adults. While both CLL and SLL affect lymphocytes, the cancers for each type are found in different sites: in CLL, the blood and bone marrow; in SLL, the lymph nodes. More than 20,000 people in the US are diagnosed with CLL or SLL each year.2 The disease is considered relapsed when it returns after a period of remission and refractory when it does not respond to treatment.

IOV-CLL-01 is a Phase 1/2 study to evaluate the safety and efficacy of autologous PBL (peripheral blood lymphocytes) therapy IOV-2001 in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL).

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