A Phase I/II Study of Regorafenib Plus Avelumab in Solid Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 212
Summary
- Conditions
- Biliary Tract Cancer
- Colorectal Cancer Not MSI-H or MMR-deficient
- Gastro-enteropancreatic Neuroendocrine Tumor
- GIST
- Hepatocellular Carcinoma
- Non -Small Cell Lung Cancer
- Oesophageal or Gastric Carcinoma
- Soft Tissue Sarcoma
- Solid Tumor, Adult
- Thyroid Cancer
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model 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 solid tumors followed by 11 phase II trials : to evaluate the association of Regorafenib at the RP2D with Avelumab in 10 distinct disease settings (advanced or metastatic tumors). to evaluate the association of a low-dose of regorafenib with avelumab in advanced or metastatic colorectal cancer Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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...
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 10 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) 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)
Tracking Information
- NCT #
- NCT03475953
- Collaborators
- Bayer
- Merck KGaA, Darmstadt, Germany
- Investigators
- Not Provided
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