A phase II trial of neoadjuvant REGorafenib in combination with nIvolumab and short-course radiotherapy iN intermediate-risk, stage II-III rectAl cancer

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-516554-22-00

Acronym

IJB-REGINA-2020

Enrollment

Registered

2024-08-29

Start date

2021-03-29

Completion date

Unknown

Last updated

2025-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally-advanced stage II-III rectal cancer

Brief summary

Complete response (CR) rate (including either pathological [pCR] or clinical complete response [cCR]) in subjects with pMMR/MSS tumours

Detailed description

CR rate in the mMiITT population (including both pMMR/MSS and dMMR/MSI-H tumours), Toxicity, Compliance to treatment, R0 resection rate, Pathological tumour regression grade (pTRG), Local recurrence rate, Distant recurrence rate, Event-free survival (EFS), Overall survival (OS), CD3 and CD8 T-cells infiltrate increase in post-treatment tumour tissue samples

Interventions

DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

DRUGRegorafenib_IJB

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Complete response (CR) rate (including either pathological [pCR] or clinical complete response [cCR]) in subjects with pMMR/MSS tumours	—

Secondary

Measure	Time frame
CR rate in the mMiITT population (including both pMMR/MSS and dMMR/MSI-H tumours), Toxicity, Compliance to treatment, R0 resection rate, Pathological tumour regression grade (pTRG), Local recurrence rate, Distant recurrence rate, Event-free survival (EFS), Overall survival (OS), CD3 and CD8 T-cells infiltrate increase in post-treatment tumour tissue samples	—

Countries

Belgium

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026