drugset / Trial / NCT03299660

Avelumab With Chemoradiation in Locally Advanced Rectal Cancer

NCT03299660 ↗

Phase 2 Completed 37 enrolled Peter MacCallum Cancer Centre, Australia
NaSingle-groupOpen-labelTreatment

Summary

This trial is investigating the inclusion of avelumab post long-course chemo-radiotherapy in patients with resectable locally advanced rectal cancer. It is hypothesised that this may enhance the pathological and imaging response rates whilst potentially reducing the relapse rates. Participants will receive standard long course chemoradiotherapy (LCCRT) treatment with radiotherapy and 5-fluorouracil (5 FU)/Capecitabine for 6 weeks, this then followed by 4 cycles of Avelumab and then surgical resection. The trial will measure disease response just prior to surgery and participants will be followed up for a minimum of 18 months (from study entry) and up to 42 months.

Timeline

Start
2018-04-30
Primary completion
2023-02-28
Completion
2023-02-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Avelumab Monoclonal antibody 10 mg/kg —
Background Capecitabine Small molecule 825 mg/m2 —
Background fluorouracil Small molecule 225 mg/m2 —

Indications