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

Sponsor
Ospedale Policlinico San Martino
Study ID
NCT05382741
Phase
PHASE2
Status
Unknown

Conditions

  • Colorectal Cancer Stage IV
  • No Evidence of Disease State

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Mar 2, 2022
Status verified
May 2023
Primary completion
Mar 2, 2024
Completion
Mar 2, 2024

Study Design

Enrollment
182 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: DURVALUMAB + REGORAFENIB
    Durvalumab 1500 mg (120-minute IV infusion) every 28 days, Regorafenib 90 mg/die orally once daily for 21 days in a 28-day cycle. Treatment will be administred up to 1 year.
  • No Intervention: CONTROL ARM
    Observation (follow-up). Crossover to the experimental arm is allowed in case of relapse.

Primary Outcome Measure

Disease Free Survival [ Time Frame: approximately 48 months ]

Central Contacts

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