Variables related to the effect:
1. Overall survival (Time from randomization until death from any cause). Measurement time: 12 and 24 months.
2. Objective response (According to Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) it will classify in “Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progression Disease (PD)). Measurement time: 4 weeks after last dose of second cycle and, 6, 9, 12 and 24 months.
3. Progression-Free Survival (Time from randomization until objective tumor progression or death). Measurement time: 24 months.
4. Response duration (Time from objective response (CR/PR) until objective tumor progression or death). Measurement time: 24 months
5. Evaluation of the percentage and absolute number in the population of peripheral blood mononuclear cells (PBMC). Measurement time: Day 0, 21, 28, 1 week before and 1 week after month 5, month 12, 18 and 24.
6. Percentage of lymphocytes in PBMC. Measurement time: 0, 21 and 28 days. Month 5, 12, 18 and 24.
7. Percentage of DC Myeloids and Plasmacytoids in PBMC. Measurement time: 0, 21 and 28 days. Month 5, 12, 18 and 24.
8. Percentage of regulatory T cells in the PBMC. Measurement time: 0, 21 and 28 days. Month 5, 12, 18 and 24.
9. Percentage of Monocytes in the PBMC. 0, 21 and 28 days. Month 5, 12, 18 and 24.
10. Arginase I, S100A8 / A9 and HMGB1 in the serum. Measurement time: 0, 21 and 28 days. Month 5, 12, 18 and 24.
11. Proliferation of T lymphocytes within PBMC. Measurement time: Day 0, 21, 28, 1 week after month 5, months 12, 18 and 24.
12. Quality of Life (EORTC QLQ-C30). Measurement time: At baseline and, 6, 12, 18 and, 24 months.
Variables related to safety:
13. Adverse events-AE (Occurrence of AE (Yes, No); Description of AE (Name of the AE); Duration of the AE (Difference between the start and end date of the event); Intensity of the AE (Mild, Moderate, Severe, Life-threatening consequences, Death related to AE, according to the Common Criteria of Adverse Event Terminology (CTCAE) version 4.0); Causality relationship (Very probable, Probable, Possible, Improbable, Not related, Not evaluable); Seriousness of the AE (Serious, Not serious); Attitude towards treatment (No change, Modification of doses, Temporary interruption, Definitive interruption); Result of AE (Recovered, Improved, Persist, Squeals)). Measurement time: in each evaluation, in each administration of the product