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

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial 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 17cohorts 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) - Cohort H: Non-small cell lung cancer (NSCLC) - Cohort I: Solid tumors (including soft-tissue sarcoma) with immune signature (TLS+). In addition, to evaluate in a phase II trial, the association of a low-dose of regorafenib (80mg/day) with avelumab : - Cohort A': colorectal not MSI-H or MMR-deficient (low dose) - Cohort J: urothelial cancer - cohort K: HPV-associated cancer with molecular confirmation p16 positive status - cohort L: triple netagtive brest cancer - cohort M: TMH-high solid tumors with status TMB-high already known - cohort N: MSI-high solid tumors with status MSI-high already known - cohort O: non clear-cell renal carcinoma - cohort P: malignant pleural mesothelioma ;

Study Design

Related Conditions & MeSH terms

  • Biliary Tract Cancer
  • Biliary Tract Neoplasms
  • Carcinoma
  • Carcinoma, Hepatocellular
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Renal Cell
  • Colorectal Cancer Not MSI-H or MMR-deficient
  • Colorectal Neoplasms
  • Gastro-enteropancreatic Neuroendocrine Tumor
  • GIST
  • Hepatocellular Carcinoma
  • HPV-Related Carcinoma
  • Kidney Neoplasms
  • Mesothelioma
  • Mesothelioma, Malignant
  • Mesotheliomas Pleural
  • Neoplasms
  • Neuroendocrine Tumors
  • Non-small Cell Lung Cancer
  • Oesophageal or Gastric Carcinoma
  • Renal Carcinoma
  • Sarcoma
  • Soft-tissue Sarcoma
  • Solid Tumor, Adult
  • Stomach Neoplasms
  • Thyroid Cancer
  • Thyroid Neoplasms
  • Triple Negative Breast Cancer
  • Triple Negative Breast Neoplasms
  • Urothelial Carcinoma
Clinical Trial Details
NCT number NCT03475953
Study type Interventional
Source Institut Bergonié
Contact Sophie COUSIN, MD
Phone +33 5.56.33.33.33
Email s.cousin@bordeaux.unicancer.fr
Status Recruiting
Phase Phase 1/Phase 2
Start date May 4, 2018
Completion date December 31, 2025
View Details
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