drugset
drugset / Trial / NCT04230759

Radiochemotherapy +/- Durvalumab for Locally-advanced Anal Carcinoma. a Multicenter, Randomized, Phase II Trial of the German Anal Cancer Study Group

NCT04230759 ↗

Phase 2 Active not recruiting 180 enrolled Goethe University
RandomizedParallel-groupOpen-labelTreatment

Summary

The RADIANCE multicenter, randomized phase II trial will assess the efficacy of durvalumab, a PD-L1 immune checkpoint inhibitor, in combination with primary mitomycin C (MMC)/5-fluorouracil (5-FU)-based radiochemotherapy (RCT) in patients with locally-advanced anal squamous cell carcinoma (ASCC).

Timeline

Start
2020-01-07
Primary completion
2026-12-31
Completion
2027-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Durvalumab Monoclonal antibody 1500 mg Intravenous
Background Mitomycin C Other / unclassified 12 mg/m2 —
Background fluorouracil Small molecule 1000 mg/m2 Intravenous

Indications

anal carcinoma