Primary analysis and 4-year follow-up of the phase III NIBIT-M2 trial in melanoma patients with brain metastases

AM Di Giacomo, V Chiarion-Sileni, M Del Vecchio… - Clinical Cancer …, 2021 - AACR
… and ipilimumab plus nivolumab in melanoma brain metastases. We report … NIBIT-M2 study,
the first phase III trial comparing these regimens with fotemustine in patients with melanoma

[HTML][HTML] … -year follow-up of advanced melanoma patients who received ipilimumab plus fotemustine in the Italian Network for Tumor Biotherapy (NIBIT)-M1 phase II …

AM Di Giacomo, PA Ascierto, P Queirolo, L Pilla… - Annals of …, 2015 - Elsevier
… phase III, NIBIT-M2 study is randomizing MM patients with brain … of ipilimumab in melanoma
patients with brain metastases, in … -PD-1 mAb nivolumab, the NIBIT-M2 study has been lately …

Immunological markers and clinical outcome of advanced melanoma patients receiving ipilimumab plus fotemustine in the NIBIT-M1 study

C Maccalli, D Giannarelli, F Capocefalo, L Pilla… - …, 2016 - Taylor & Francis
… Along this line the phase III NIBIT-M2 trial, comparing the … and fotemustine in patients with
advanced melanoma (NIBIT-M1): … Three-year follow-up of advanced melanoma patients who …

Guadecitabine plus ipilimumab in unresectable melanoma: the NIBIT-M4 clinical trial

AM Di Giacomo, A Covre, F Finotello, D Rieder… - Clinical Cancer …, 2019 - AACR
… mg/m 2 /day in case no DLTs were observed at 30 mg/m 2 /day… also in the initial six patients
treated at 45 mg/m 2 /day, the … on melanoma cells induced by treatment in our NIBIT-M4 …

Safety and immunobiological activity of guadecitabine sequenced with ipilimumab in metastatic melanoma patients: The phase Ib NIBIT-M4 study.

AM Di Giacomo, A Covre, F Finotello, D Rieder… - 2019 - ascopubs.org
… of advanced melanoma. Methods: Patients with unresectable Stage III/IV melanoma
received escalating doses of guadecitabine 30, 45 or 60 mg/m 2 subcutaneously on Days 1…

Guadecitabine plus ipilimumab in unresectable melanoma: five-year follow-up and correlation with integrated, multiomic analysis in the NIBIT-M4 trial

TM Rosaria Noviello, AM Di Giacomo, FP Caruso… - medRxiv, 2023 - medrxiv.org
… escalation, single-center NIBIT-M4 study, enrolled pre-treated or untreated patients with
unresectable Stage III or IV melanoma, to receive guadecitabine 30, 45, or 60 mg/m 2 /day sc on …

… ipilimumab plus nivolumab or ipilimumab plus fotemustine vs fotemustine in patients with melanoma metastatic to the brain: Primary analysis of the phase III NIBIT-M2 …

AM Di Giacomo, VC Sileni, M Del Vecchio… - Annals of …, 2020 - annalsofoncology.org
melanoma (MM) patients (pts) with BM for over two decades. The Italian Network for Tumor
Biotherapy (NIBIT… We here report the results of the primary analysis of the NIBIT-M2 study, the …

A phase II study combining ipilimumab and fotemustine in patients with metastatic melanoma: The NIBIT-M1 trial.

AM Di Giacomo, PA Ascierto, E Fonsatti… - Journal of Clinical …, 2011 - ascopubs.org
… The Italian Network for Tumor Biotherapy (NIBIT) … NIBIT-M1 is a phase II, open-label,
single arm study that enrols unresectable stage III or IV cutaneous melanoma pts in seven NIBIT

Guadecitabine plus ipilimumab in unresectable melanoma: five-year follow-up and integrated multi-omic analysis in the phase 1b NIBIT-M4 trial

TMR Noviello, AM Di Giacomo, FP Caruso… - Nature …, 2023 - nature.com
… escalation, single-center NIBIT-M4 study, enrolled pre-treated or untreated patients with
unresectable Stage III or IV melanoma, to receive guadecitabine 30, 45, or 60 mg/m 2 /day sc on …

[HTML][HTML] … plus ipilimumab in melanoma patients with asymptomatic brain metastases: 7-year outcomes and quality of life from the multicenter phase III NIBIT-M2 trial

AM Di Giacomo, V Chiarion-Sileni… - European Journal of …, 2024 - Elsevier
NIBIT-M2 study provide the longest evidence of the efficacy of ipilimumab plus nivolumab in
melanoma patients … year primary analysis of the NIBIT-M2 study demonstrated that treatment …