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Review
. 2019 Jan;68(1):143-150.
doi: 10.1007/s00262-018-2286-x. Epub 2018 Dec 18.

The Italian Network for Tumor Bio-Immunotherapy (NIBIT) Foundation: ongoing and prospective activities in immuno-oncology

Anna Maria Di Giacomo  1 , Alessia Covre  2 , Gianluca Giacobini  2 , Ramy Ibrahim  3 , Jaclyn Lyman  3 , Pier Giorgio Natali  4 , Michele Maio  2
Affiliations
Review

The Italian Network for Tumor Bio-Immunotherapy (NIBIT) Foundation: ongoing and prospective activities in immuno-oncology

Anna Maria Di Giacomo et al. Cancer Immunol Immunother. 2019 Jan.

Abstract

The ongoing revolution in cancer immunotherapy stems from the knowledge that distinct immune-checkpoints regulate the physiological crosstalk between and among immune cells by delivering inhibitory or activating signals. These notions, and the availability of mAb directed to diverse immune-checkpoint molecules, have led to a significant clinical improvement in cancer treatment. In this scenario, further achievements are undoubtedly to be expected from the contribution of novel, proof-of-principle clinical trials designed to explore the therapeutic efficacy of new immunotherapy-based combinations and treatment sequences. Along these lines, the clinical translation of pre-clinical evidence generated by non-profit research entities is likely to provide a significant contribution to gaining new insights that will further boost the field of cancer immunotherapy. To pursue this goal, and to provide comprehensive educational programs in immune-oncology (I-O), several national and global networks have been revitalized or newly established in recent years. This rapidly evolving scenario led the Board of Directors of the Italian Network of Tumor Bio-Immunotherapy (NIBIT) to establish the NIBIT Foundation. This Focused Research Review summarizes the main ongoing and prospective I-O activities of the NIBIT Foundation.

Keywords: Clinical trials; Immune-oncology; Immunotherapy; Melanoma; Mesothelioma; NIBIT.

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Conflict of interest statement

Anna Maria Di Giacomo served on the advisory board of Bristol-Myers Squibb, Incyte, Pierre Fabre, Glaxo Smith Kline and she is a member of the scientific board of directors of the NIBIT Foundation; Ramy Ibrahim is a member of the scientific advisory board of: Arcus, Harpoon, Immunovaccine and ImaginAB;Jaclyn Lyman is a PICI employee; Pier Giorgio Natali is a member of the scientific board of directors of the NIBIT Foundation; Michele Maio served on advisory boards of Bristol-Myers Squibb, Roche-Genentech, Merck Sharp Dohme and AstraZeneca-MedImmune, and he is the president of the NIBIT Foundation. The authors declare that there are no other conflicts of interest.

Figures

Fig. 1
Fig. 1
NIBIT-M2 study design. Melanoma patients with asymptomatic, untreated brain metastases will be randomized to receive fotemustine (ARM A), the combination of ipilimumab and fotemustine (ARM B), or the combination of ipilimumab and nivolumab (ARM C)
Fig. 2
Fig. 2
NIBIT-M4 study design. The NIBIT-M4 trial is a phase 1b, dose-escalation study in unresectable Stage III or Stage IV MM patients, amenable to serial tumor biopsies. The dose escalation of guadecitabine follows a 3 + 3 design: cohorts of 3–6 patients receive guadecitabine s.c. on W 0, 3, 6, 9, days 1–5 q21d and ipilimumab i.v.at 3 mg/kg on W 1, 4, 7 and 10, day 1 q21d. Translational studies on tumor biopsies and on blood samples, planned in the study, are illustrated
See this image and copyright information in PMC

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