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) 6

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 7 cohorts of advanced or metastatic tumors :

Cohort A: Colorectal cancer not MSI-H or MMR-deficient
Cohort B: GIST
Cohort C: Oesophageal or gastric carcinoma
Cohort D: Biliary tract cancer, hepatocellular carcinoma
Cohort E: Soft-tissue sarcoma (STS)
Cohort F: Radioiodine-refractory differentiated thyroid cancer (RR-DTC)
Cohort G: Neuroendocrine gastroenteropancreatic tumors (GEP-NETs)