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

NCT ID: NCT05382741

Last Updated: 2023-05-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 182 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-02
• Study Completion Date: 2024-03-02

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Durvalumab Injection for intravenous use 500 mg vial solution for infusion

Intervention Type: DRUG

MEDI4736

Regorafenib 30 mg capsules

Intervention Type: DRUG

BAY73-4506

CONTROL ARM

Observation (follow-up).

Crossover to the experimental arm is allowed in case of relapse.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Durvalumab Injection for intravenous use 500 mg vial solution for infusion

MEDI4736

Intervention Type: DRUG

Regorafenib 30 mg capsules

BAY73-4506

Intervention Type: DRUG

Other Intervention Names

Imfinzi; Stivarga

Eligibility Criteria

Inclusion Criteria

1. ≥ 18 years; ECOG PS 0-1;

2. Body weight >30 kg;

3. Histologically confirmed diagnosis of colorectal adenocarcinoma;

4. Patients must be in NED after completion of any treatments for stage IV CRC, including resections, RFA; RT with or without neoadjuvant/adjuvant therapies or CR after chemotherapy;

5. Patients must be randomized within 10 weeks since the achievement of the NED state. Those who have also received adjuvant therapy following the locoregional treatment are still eligible, provided they are randomized within 4 weeks since the last chemotherapy cycle;

6. NED state ascertained by means of CT scan and/or PET scan and/or MRI scan;

7. Life expectancy of at least 12 weeks;

8. CEA within normal limits;

9. No residual toxicity from previous chemotherapy;

10. Adequate organ function;

Exclusion Criteria

1. MSI/dMMR patients;

2. Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia and vitiligo;

3. Active or prior documented autoimmune or inflammatory disorders;

4. Relevant concomitant comorbidities;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Associazione Italiana per la Ricerca sul Cancro

OTHER

Sponsor Role: collaborator

Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente

OTHER

Sponsor Role: collaborator

Bayer

INDUSTRY

Sponsor Role: collaborator

Ospedale Policlinico San Martino

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alberto Sobrero, MD

Role: PRINCIPAL_INVESTIGATOR

OSPEDALE SAN MARTINO IRCCS

Locations

IRCCS Ospedale Policlinico San Martino

Genoa, Liguria, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Alberto Sobrero, MD

Role: CONTACT

alberto.sobrero@hsanmartino.it

+39 010 555 4386

Alessandro Pastorino, MD

Role: CONTACT

alessandro.pastorino@hsanmartino.it

+39 010 555 4386

Facility Contacts

Alberto Sobrero, MD

Role: primary

alberto.sobrero@hsanmartino.it

+39 010 555 4386

Alessandro Pastorino, MD

Role: backup

alessandro.pastorino@hsanmartino.it

+39 010 555 4386

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

VIVA TRIAL

Identifier Type: -

Identifier Source: org_study_id