Overview

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

Status:
Not yet recruiting

Trial end date:
2025-03-01

Target enrollment:

Participant gender:

Summary

This is a run-in, randomized, non-comparative, phase II study designed according to a two stages optimal design by Simon. This phase II design will be preceded by a safety evaluation after the first cohort of 6 patients to preserve a high-grade of overlapping and/or unexpected toxicity rate. The study will assess the immune-objective response rate (iORR) (assessed using iRECIST criteria) of nivolumab combined with ipilimumab and guadecitabine or nivolumab combined with ipilimumab, in Melanoma and non-small cell lung cancer (NSCLC) patients resistant to anti-PD-1/PD-L1 therapy. Immune biologic correlates to treatment will be assessed as exploratory endpoints.

Phase:

Phase 2

Details

Lead Sponsor:

Italian Network for Tumor Biotherapy Foundation

Collaborators:

Astex Pharmaceuticals, Inc.
Bristol-Myers Squibb

Treatments:

Azacitidine
Guadecitabine
Ipilimumab
Nivolumab