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Ipilimumab and Nivolumab with Chemoradiotherapy in Rectal Cancer
NCT04124601Phase 2
Key facts
- Status
- Completed
- Start
- Jun 2020
- Primary completion
- Mar 2024
- Countries
- 1
- Sponsor
- Johannes Längle
- Modality
- Monoclonal Antibodies
- Drugs
- ipilimumabnivolumab
- Conditions
- rectal cancer
01
Overview
Phase 2, randomised, open-label trial of ipilimumab and nivolumab in rectal cancer (2 arms), sponsored by Johannes Längle. Primary endpoint: Incidence of treatment-emergent adverse events at 20 weeks. Started Jun 2020; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Neoadjuvant Chemoradiotherapy
Standard CRT
Neoadjuvant Chemoradiotherapy + Ipi/Nivo
Standard CRT with sequential Ipilimumab and Nivolumab
03
Endpoints
Primary
Incidence of treatment-emergent adverse events
Secondary
Radiographic therapy response
Pathologic therapy response
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