NCT04159974

RICE: Radio-Immuno-Chemotherapy of Cancer of the Esophagus

A Phase II Trial to Evaluate Safety and Efficacy of Adding Durvalumab (MEDI4736) to Standard Neoadjuvant Radiochemotherapy and of Adjuvant Durvalumab +/- Tremelimumab in Locally Advanced Esophageal Adenocarcinoma and to Evaluate Biomarkers Predictive for Response to Immune Checkpoint Inhibition

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: University of Cologne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A phase II trial to evaluate safety and efficacy of adding durvalumab (MEDI4736) to standard neoadjuvant radiochemotherapy and of adjuvant durvalumab +/- tremelimumab in locally advanced esophageal adenocarcinoma and to evaluate biomarkers predictive for response to immune checkpoint inhibition

Detailed description

Short Study Title: RICE - Radio-Immuno-Chemotherapy of Cancer of the Esophagus Study Phase: Phase II Research hypothesis: The investigators aim at evaluating if (I) esophageal cancer is susceptible to immunotherapeutic approaches based on interference with the PD1 / PDL1 axis, if (II) treatment of locally advanced tumors by immunotherapeutic approaches increases cure rate and if (III) combination with radiotherapy is feasible and increases anti-tumor immunity. Primary Objectives: The primary objective is to evaluate safety and efficacy (measured by an increase of pathological complete response rate from 20% to 35%) of the fully human monoclonal IgG1 antibody durvalumab targeting the programmed death-ligand 1 (PD-L1) in combination with neoadjuvant radiochemotherapy, followed by surgery for locally advanced esophageal cancer and cancer of the gastric esophageal junction (GEJ).

Conditions

• Esophageal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Durvalumab 50 MG/ML	IV Infusion
DRUG	Tremelimumab	IV Infusion, Combination with Durvalumab

Timeline

• Start date: 2019-09-30
• Primary completion: 2024-06-01
• Completion: 2024-06-01
• First posted: 2019-11-12
• Last updated: 2024-05-09

Locations

2 sites across 1 country: Germany