A Phase I/II Study of Regorafenib Plus Avelumab in Solid Tumors (REGOMUNE)

A Phase I/II Study of Regorafenib Plus Avelumab in Solid Tumors (REGOMUNE)

Solid Tumors

Recruiting

1/2

Start Date 05/04/2018

Age of Trial (yrs) 7

Gleevec-resistant

Kit inhibitor + PD-L1 Inhibitor

Block KIT + Stimulate the immune system

Specifically GIST plus other cancers

REGOMUNE IB 2017-01 2016-005175-27 ( EudraCT Number )

Institut Bergonié Collaborators: Bayer Merck KGaA, Darmstadt, Germany

Sophie COUSIN, MD +33 5.56.33.33.33 s.cousin@bordeaux.unicancer.fr Simone Mathoulin-Pelissier, MD, PhD s.mathoulin@bordeaux.unicancer.fr

Oral Intravenous

Detailed Description:

This is a multicenter, prospective open-labeled phase Ib trial based on a dose escalation study design (3+3 traditional design) assessing three dose levels of Regorafenib given in combination with Avelumab (no dose escalation for Avelumab) in patients with advanced digestive solid tumors followed by independent phase II trials to evaluate the association of Regorafenib at the RP2D with Avelumab in 17 cohorts (A to P) of advanced or metastatic tumors : Cohort B: GIST

Arms:
Experimental: Phase 2 : cohort B Regorafenib + Avelumab
Treatment by Avelumab will be administrated by intravenous 1-hour infusion every 2 weeks starting at Cycle 1 Day 15. Regorafenib will be taken orally once daily for three weeks on/ one week off..

Secondary Outcome Measures:
Phase II (cohort B): assessment of the antitumor activity of regorafenib
Assessment of the antitumor activity of regorafenib when prescribed in association with avelumab based on CHOI criteria
[Time Frame: throughouth the treatment period, an average of 6 months]

Inclusion Criteria:
1. Histology

Dose escalation part: histologically confirmed non MSI-H or deficient-MMR colorectal cancer, or GIST, or esophageal or gastric carcinoma or hepatobiliary cancers,

Phase II trials : histologically confirmed
non MSI-H or deficient-MMR colorectal cancer (cohort A),
or GIST (cohort B). As recommended diagnosis by INCa, patients with GIST must have histologically confirmed by central review, except if it has been already confirmed by the RRePS Network