Phase II randomized study evaluating 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. The PragmaTIL

Advanced selected solid tumors: melanoma, non-small cell lung cancer (NSCLC) and cervical cancer.

Mean number of predefined grade ≥3 relevant adverse events per treatment arm during the first two weeks from the first dose of interleukin (IL-2 analog ANV419 or HD-IL-2) administered. Predefined relevant AEs are rash, fatigue, myalgia, chills, fever, hypotension, arrhythmia, hypoxia, dyspnea, pulmonary distress, oliguria, edema, weight gain, diarrhea, confusion, headache, anxiety, ALT increase, AST increase, bilirubin increase, and serum creatinine increase according to the NCI CTCAE v5.0., Change of PRO CTCAE composite score (score 0-3 for each symptom) of selected events (diarrhea, fatigue, shortness of breath, rash, swelling, chills, heart palpitations, insomnia, anxious, sad, headache and muscle pain) from the baseline (within 3 days before TIL infusion) assessment to the first post-treatment evaluation

Nature, frequency, and severity of treatment related adverse events according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) per treatment arm, Overall Response Rate (ORR) per RECIST v1.1 as assessed by investigator., Duration of Response (DOR) per RECIST v1.1 as assessed by investigator., Tumor size calculated as the percentage change from baseline in tumor size (TS) to the time of the best response., Progression Free Survival (PFS), Overall survival (OS), Trajectories of quality of life and symptomatology using the EORTC QLQ-C30 and EQ-5D-5L questionnaires., Patient reported Anxiey and Depression as measured by the Hospital Anxiety and Depression Scale (HADS), Physiological parameters (Heartbeat, mobility, SpO2, and sleep cycle) captured by wearable device (Garmin VivoSmart 5 smartwatch), Qualitative evaluation of patient experience regarding themes around the care journey, expectations and uncertainty whilst undergoing TILs therapy through in-person or virtual qualitative interviews conducted before disease re-evaluation., Direct and indirect costs of TIL-ACT using HD-IL-2 and ANV419

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