Evaluation of a Pragmatic Approach to Adoptive Cell Therapy (ACT) Using an IL2 Analog (ANV419) vs High Dose IL2 After Tumor Infiltrating Lymphocytes (TIL) Therapy in Patients With Melanoma, NSCLC and Cervical Cancer (PragmaTIL)

This is a an open-label, randomized, pragmatic multicenter phase II clinical trial to compare the safety, quality of life and efficacy of current protocols of adoptive cell therapy based on tumorinfiltrating lymphocytes (TIL-ACT) established at each institution facility through the randomization between two types of following interleukin used for engrafting and in vivo expansion of TILs: standard high-dose (HD) IL-2(600.000 IU/kg) or ANV419. Total number of patients included in the trial will be 40. Of the total 40 patients, the first 10 patients recruited in the study will be metastatic melanoma patients. The melanoma and non-melanoma cohorts will be equally distributed between the two arms. Patients will be randomized to start treatment with either HD-IL-2 (Control arm) or with ANV419 (Experimental arm). The objectives of this study are the following: Primary objectives: * To determine whether TIL-ACT using the IL-2 analog ANV419 reduces the mean number of predefined grade ≥3 relevant adverse events related to interleukin use (based on Common Terminology Criteria for Adverse Events v5.0 - CTCAE v5.0) compared to TIL-ACT using HD-IL-2. * To determine whether TIL-ACT using the IL-2 analog improves patient´s reported outcomes (PRO) compared to TIL-ACT using HD-IL-2 Secondary objectives: * To evaluate the safety and the tolerability of TIL-ACT using the IL-2 analog ANV419 compared to TIL-ACT using HD-IL-2. * To evaluate short-term efficacy outcomes in patients receiving the IL-2 analog ANV419 or HD-IL-2. * To evaluate long-term efficacy outcomes in patients receiving the IL-2 analog ANV419 or HD-IL-2. * To evaluate the quality of life (QoL) and symptomatology in patients receiving the IL-2 analog ANV419 or HD-IL-2. * To evaluate anxiety and depression in patients receiving the IL-2 analog ANV419 or HD-IL-2. * To develop the health technology assessment (HTA) of TIL-ACT using ANV419, via the analysis of cost-effectiveness, budget impact, reimbursement strategies, user acceptance, and technical feasibility. This assessment, together with a social return of investment (SROI) analysis, will provide relevant information to participant member states regarding the possibility of implementing optimized and affordable treatments in their healthcare systems. Exploratory objectives: * To evaluate the impact of the different cytokine regimens on CD8+, NK and Treg proliferation, cytokine secretion profile, as well as the persistence and transcriptomic/phenotypic profile of the infused TIL product at different times following TIL infusion. * To correlate the presence and persistence of tumor- and neoantigen- reactive TIL and their transcriptomic/phenotypic profile with clinical outcome. * To evaluate the influence of tumor and neoantigen heterogeneity measured through tumor and cell free DNA sequencing prior to and during treatment. * To evaluate biometric physiological parameters (mobility, heart rate, SpO2 and sleep cycle) through wearable devices during and after treatmen