A Study of NIVO Plus IPI and Guadecitabine or NIVO Plus IPI in Melanoma and NSCLC Resistant to Anti-PD1/PDL1

PHASE2UnknownINTERVENTIONAL
Enrollment

184

Participants

Timeline

Start Date

March 31, 2020

Primary Completion Date

March 31, 2023

Study Completion Date

March 31, 2025

Conditions
MelanomaNon Small Cell Lung Cancer
Interventions
DRUG

Ipilimumab plus nivolumab plus guadecitabine

"Cohort A Melanoma ARM A Guadecitabine: 30-45 mg/m2 s.c./day 1-5 q21 x 4 cycles and from W13 q28 x 6 cycles Ipilimumab: 3 mg/Kg i.v. plus nivolumab 1 mg/Kg i.v. on W1, 4, 7 and 10 and from W14 nivolumab 480 mg i.v. q4 wks for 2 years~Cohort B NSCLC ARM A Guadecitabine: 30-45 mg/m2 s.c./day 1-5 q21 x 4 cycles and from W13 q28 x 6 cycles Ipilimumab: 1 mg/Kg i.v.q 6wks plus nivolumab 3 mg/Kg i.v. q2 wks until W13, then ipilimumab: 1 mg/Kg i.v. q 6wks plus nivolumab 480mg i.v. q4wks for 2 years"

DRUG

Ipilimumab plus nivolumab

"Cohort A Melanoma ARM B Ipilimumab: 3 mg/Kg i.v. plus nivolumab 1 mg/Kg i.v. on W1, 4, 7 and 10 and from W14 nivolumab 480 mg i.v. q4 wks for 2 years~Cohort B NSCLC ARM B Ipilimumab: 1 mg/Kg i.v. q 6wks plus nivolumab 3 mg/Kg i.v. q2 wks until W13, then ipilimumab: 1 mg/Kg i.v. q6 wks plus nivolumab 480mg i.v. q4wks for 2 years."

Trial Locations (1)

53100

Center for Immuno-Oncology, University Hospital of Siena, Siena

All Listed Sponsors
collaborator

Astex Pharmaceuticals, Inc.

INDUSTRY

collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Italian Network for Tumor Biotherapy Foundation

OTHER