The study of durvalumab plus regorafenib vs untreated control in stage IV colorectal cancer

The research company Ospedale Policlinico San Martino is conducting the clinical trial Adjuvant Durvalumab Plus Regorafenib vs Untreated Control in Stage IV Colorectal Cancer Patients With no Evidence of Disease (NED): VIVA Trial (VIVA).

The purpose of this study is to evaluate the efficacy of Durvalumab plus Regorafenib versus observation for patients with stage IV colorectal cancer achieving the no evidence of disease state.

The NED state can be achieved in any line of treatment and it is defined as: 1. R0 resection for surgery, 2. the complete ablation defect covering the lesion on CT scan for radiofrequency, 3. the erogation of ≥ 60 Gy for stereotactic radiotherapy, 4. complete response to antineoplastic treatments on CT scan. In all these cases CEA and CA 19.9 must be within normal limits at the time of randomization. Participants in this study will receive: Experimental arm: Regorafenib 90 mg d1-21 every 28 days plus Durvalumab 1500 mg every 28 days for 1 year Control arm: Observation (crossover to Experimental arm is allowed in case of relapse) Tumor assessment will be performed every 12 weeks.

It is planned to include 182 participants.

Actual study start date is March 2, 2022. The researchers expect to complete the study by March 2, 2024.

One primary outcome measure is Disease Free Survival, Disease free survival, defined as the time from the date of randomization to the earliest documented disease relapse (local or distant), death due to any cause or two consecutive increases of CEA above upper limit (time gap no longer than 30 days).

Further details can be found here: https://ichgcp.net/clinical-trials-registry/NCT05382741.