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

Sponsor
University of Cologne
Study ID
NCT04159974
Phase
PHASE2
Status
Unknown

Conditions

  • Esophageal Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

Start date
Sep 30, 2019
Status verified
May 2023
Primary completion
Jun 30, 2024
Completion
Jun 30, 2024

Study Design

Enrollment
56 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Durvalumab
    Treatment arm A will receive durvalumab IV in a dosage of 1500mg every four weeks for 12 months as mono therapy.
  • Experimental: Durvalumab + Tremelimumab
    Treatment arm B receives durvalumab in a dosage of 1500mg every 4 weeks (-3/+7 days) for 12 months post-surgery. In addition these patients receive tremelimumab IV in a fixed dose of 75mg for the first four months on day 1; 29; 57; 85 (-3/+7).

Primary Outcome Measure

Evaluation of Safety and efficacy (measured by an increase of pathological complete response rate) [ Time Frame: Calculated once at the end of study (24 months after the end of treatment) ]

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