NCT05382741

Adjuvant Durvalumab Plus Regorafenib vs Untreated Control in Stage IV Colorectal Cancer Patients With no Evidence of Disease (NED): VIVA Trial

Study of Adjuvant Durvalumab (MEDI4736) Plus Regorafenib vs Untreated Control in Stage IV Colorectal Cancer Patients With no Evidence of Disease (NED): VIVA Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 182 (estimated)
• Sponsor: Ospedale Policlinico San Martino · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The safety run-in phase is planned for the first 4 patients randomized to the experimental arm using a starting dose of 60 mg/die of Regorafenib (and fixed 1500 mg of Durvalumab), to be escalated after 2 months to 90 mg/die if \< 2 patients report serious adverse events.

Conditions

• Colorectal Cancer Stage IV
• No Evidence of Disease State

Interventions

Type	Name	Description
DRUG	Durvalumab Injection for intravenous use 500 mg vial solution for infusion	MEDI4736
DRUG	Regorafenib 30 mg capsules	BAY73-4506

Timeline

• Start date: 2022-03-02
• Primary completion: 2024-03-02
• Completion: 2024-03-02
• First posted: 2022-05-19
• Last updated: 2023-05-17

Locations

1 site across 1 country: Italy