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) 6.5 |
|
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 |
Name |
Address |
City |
State |
Zip |
Country |
229 Cours Argonne |
Bordeaux |
Gironde |
33076 |
France |
|
Montpellier |
Herault |
34298 |
France |
||
Toulouse |
31052 |
France |