NCT03299660

Avelumab With Chemoradiation in Locally Advanced Rectal Cancer

Phase II Trial PD-L1/PD-1 Blockade Avelumab (MSB0010718C) With Chemoradiotherapy for Locally Advanced Resectable Rectal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Peter MacCallum Cancer Centre, Australia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
DRUG	Avelumab	Avelumab 10 mg/Kg every 2 weeks for 4 cycles post LCCRT
DRUG	5 Fluorouracil	5FU continuous infusion 225mg/m2/day during radiotherapy
DRUG	Capecitabine Pill	Can be administered in place of 5FU infusion. Dose = 825 mg/m2 twice a day on each day of radiotherapy
RADIATION	Radiotherapy	50.4 Gy in 28 fractions delivered over 5.5 weeks as 5 fractions/week
PROCEDURE	Surgical Resection	Surgical resection of tumour mass post radiotherapy and chemotherapy

Timeline

• Start date: 2018-04-30
• Primary completion: 2023-02-28
• Completion: 2023-02-28
• First posted: 2017-10-03
• Last updated: 2023-03-16

Locations

7 sites across 1 country: Australia