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

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.

Conditions

• Colorectal Cancer Not MSI-H or MMR-deficient
• GIST
• Oesophageal or Gastric Carcinoma
• Biliary Tract Cancer
• Hepatocellular Carcinoma
• Soft-tissue Sarcoma
• Thyroid Cancer
• Gastro-enteropancreatic Neuroendocrine Tumor
• Non-small Cell Lung Cancer
• Solid Tumor, Adult
• Urothelial Carcinoma
• HPV-Related Carcinoma
• Triple Negative Breast Cancer
• Renal Carcinoma
• Mesotheliomas Pleural

Interventions

DRUG

Phase 1 : Regorafenib

A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.). Patients will be allocated 3 dose levels of Regorafenib following a 3 + 3 design.

DRUG

Phase 1 : Avelumab

A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.). Avelumab will be administered on cycle 1 Day 15 as a 1-hour intravenous (IV) infusion (10mg/kg), repeated every two weeks thereafter (ie. Day 1 and Day 15 of each subsequent cycle, as a 1-hour intravenous infusion).

DRUG

Phase 2 : Regorafenib

Phase 2 : Regorafenib - All patients will be treated at the RP2D of regorafenib defined in the preliminary phase 1 trial with the same schedule as in the phase I.

DRUG

Phase 2 : Avelumab

Phase 2 : Avelumab - All patients will be treated with avelumab with the same schedule as in the phase 1 trial.

DRUG

Phase 2: low-dose Regorafenib

Phase 2 : Regorafenib - All patients will be treated at a fixed low-dose of regorafenib of 80 mg/day

Sponsors & Collaborators

• Bayer

  collaborator INDUSTRY

• Merck KGaA, Darmstadt, Germany

  collaborator INDUSTRY

• Institut Bergonié

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-05-04

Primary Completion

2024-12-31

Completion

2025-12-31

Countries

• France

Study Locations