TRIAL DETAIL

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

Drug:
Trial Name:
A Phase I/II Study of Regorafenib Plus Avelumab in Solid Tumors (REGOMUNE)
NCT#:
Conditions:
Solid Tumors
Status:
Recruiting
Phase:
1/2
Start Date 05/04/2018
Age of Trial (yrs) 2.3
Treatment Phase:
Gleevec-resistant
Drug Category:
Kit inhibitor + PD-L1 Inhibitor
Strategy:
Block KIT + Stimulate the immune system
Trial Type:
Specifically GIST plus other cancers
Other Protocol IDs:
REGOMUNE IB 2017-01 2016-005175-27 ( EudraCT Number )
Sponsor:
Institut Bergonié Collaborators: Bayer Merck KGaA, Darmstadt, Germany
Patient Contact:
Sophie COUSIN, MD +33 5.56.33.33.33 s.cousin@bordeaux.unicancer.fr Simone Mathoulin-Pelissier, MD, PhD s.mathoulin@bordeaux.unicancer.fr
Contact email:
Contact Phone:
Randomized:
IV or Oral:
Oral Intravenous
Trial Notes:

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)

Trial Links

Trial Results

Drug Information

Trial Sites

Name
Address
City
State
Zip
Country
229 Cours Argonne
Bordeaux
Gironde
33076
France
Montpellier
Herault
34298
France
Toulouse
31052
France