Neoadjuvant Chemoradiotherapy With Sequential Ipilimumab and Nivolumab in Rectal Cancer
NCT04124601 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2024-04-23
Summary
This prospective randomized, open-label, multicenter, phase II clinical trial investigates the safety and tolerability of standard neoadjuvant chemoradiotherapy (CRT) with sequential ipilimumab and nivolumab in rectal cancer.
Conditions
Interventions
- RADIATION
-
Chemoradiotherapy
Capecitabine tablet with fractionated radiotherapy
- DRUG
-
Infusion
- DRUG
-
Infusion
Sponsors & Collaborators
- collaborator INDUSTRY
-
Johannes Laengle, MD, PhD
lead OTHER
Principal Investigators
-
Michael Bergmann, MD · Division of Visceral Surgery, Department of General Surgery, Medical University of Vienna
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 100 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-06-01
- Primary Completion
- 2024-03-15
- Completion
- 2024-03-15
- FDA Drug
- Yes
Countries
- Austria
Study Locations
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