NCT03475953: REGOMUNE

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

Status unknown Phase 1, PHASE2 Last updated 3 March 2023

What this trial tests

Phase 1, PHASE2 trial testing Phase 1 : Regorafenib in Colorectal Cancer Not MSI-H or MMR-deficient in 747 participants. Status unknown.

Timeline

4 May 2018

Primary endpoint
31 December 2024

31 December 2025

Quick facts

Lead sponsor	Institut Bergonié
Phase	Phase 1, PHASE2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	747
Start date	4 May 2018
Primary completion	31 December 2024
Estimated completion	31 December 2025
Sites	7 locations across France

Drugs / interventions tested

• Phase 1 : Regorafenib — full drug profile →
• Phase 1 : Avelumab — full drug profile →
• Phase 2 : Regorafenib — full drug profile →
• Phase 2 : Avelumab — full drug profile →
• Phase 2: low-dose Regorafenib — full drug profile →

Conditions studied

• Colorectal Cancer Not MSI-H or MMR-deficient — all drugs for Colorectal Cancer Not MSI-H or MMR-deficient →
• GIST — all drugs for GIST →
• Oesophageal or Gastric Carcinoma — all drugs for Oesophageal or Gastric Carcinoma →
• Biliary Tract Cancer — all drugs for Biliary Tract Cancer →

Sponsor

Institut Bergonié — full company profile →

Who can join

18 and older, any sex, with Colorectal Cancer Not MSI-H or MMR-deficient or GIST. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Assessment of the efficacy and safety of Regorafenib and Avelumab in patients with advanced or metastatic solid tumors (ten cohorts), once the Recommanded Phase II Dose (RP2D) has been determined (phase I trial).

Assessement of the efficacy and safety of a low-dose of regorafenib (80mg/day) with avelumab in patients with advanced or metastatic colorectal tumors.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeted therapy for hepatocellular carcinoma.
   Huang A, Yang XR, Chung WY, Dennison AR, et al · · 2020 · cited 548× · PMID 32782275 · DOI 10.1038/s41392-020-00264-x
2. Tyrosine kinase inhibitors for solid tumors in the past 20 years (2001-2020).
   Huang L, Jiang S, Shi Y. · · 2020 · cited 305× · PMID 33109256 · DOI 10.1186/s13045-020-00977-0
3. PD-L1, TMB, MSI, and Other Predictors of Response to Immune Checkpoint Inhibitors in Biliary Tract Cancer.
   Rizzo A, Ricci AD, Brandi G. · · 2021 · cited 207× · PMID 33535621 · DOI 10.3390/cancers13030558
4. Anti-angiogenic Agents in Combination With Immune Checkpoint Inhibitors: A Promising Strategy for Cancer Treatment.
   Song Y, Fu Y, Xie Q, Zhu B, et al · · 2020 · cited 198× · PMID 32983126 · DOI 10.3389/fimmu.2020.01956
5. Current and emerging therapeutic approaches for colorectal cancer: A comprehensive review.
   Kumar A, Gautam V, Sandhu A, Rawat K, et al · · 2023 · cited 159× · PMID 37206081 · DOI 10.4240/wjgs.v15.i4.495
6. Recent advances in systemic therapy for hepatocellular carcinoma.
   Zhang H, Zhang W, Jiang L, Chen Y. · · 2022 · cited 150× · PMID 35000616 · DOI 10.1186/s40364-021-00350-4
7. Advances in drug development for hepatocellular carcinoma: clinical trials and potential therapeutic targets.
   Luo XY, Wu KM, He XX. · · 2021 · cited 144× · PMID 34006331 · DOI 10.1186/s13046-021-01968-w
8. Gastric cancer immunosuppressive microenvironment heterogeneity: implications for therapy development.
   Yasuda T, Wang YA. · · 2024 · cited 139× · PMID 38600020 · DOI 10.1016/j.trecan.2024.03.008