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

NCT05382741 | Unknown Phase 2 DMC

• 1 other identifier: VIVA TRIAL
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

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. 1.R0 resection for surgery,
2. 2.the complete ablation defect covering the lesion on CT scan for radiofrequency,
3. 3.the erogation of ≥ 60 Gy for stereotactic radiotherapy,
4. 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.

Conditions

Colorectal Cancer Stage IV; No Evidence of Disease State

Keywords

NED state; adjuvant; tyrosine kinase inhibitors; immunotherapy

Outcome Measures

Primary Outcomes (1)

• 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).

  approximately 48 months

Secondary Outcomes (3)

• 18 months - Disease Free Survival

  approximately 48 months

• Overall Survival

  approximately 48 months

• Incidence of adverse events

  approximately 48 months

Study Arms (2)

DURVALUMAB + REGORAFENIB

EXPERIMENTAL

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.

Drug: Durvalumab Injection for intravenous use 500 mg vial solution for infusion; Drug: Regorafenib 30 mg capsules

CONTROL ARM

NO INTERVENTION

Observation (follow-up). Crossover to the experimental arm is allowed in case of relapse.

Interventions

Durvalumab Injection for intravenous use 500 mg vial solution for infusion DRUG

MEDI4736

Also known as: Imfinzi

DURVALUMAB + REGORAFENIB

Regorafenib 30 mg capsules DRUG

BAY73-4506

Also known as: Stivarga

DURVALUMAB + REGORAFENIB

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years; ECOG PS 0-1;
• Body weight \>30 kg;
• Histologically confirmed diagnosis of colorectal adenocarcinoma;
• 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;
• 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;
• NED state ascertained by means of CT scan and/or PET scan and/or MRI scan;
• Life expectancy of at least 12 weeks;
• CEA within normal limits;
• No residual toxicity from previous chemotherapy;
• Adequate organ function;

You may not qualify if:

• MSI/dMMR patients;
• Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia and vitiligo;
• Active or prior documented autoimmune or inflammatory disorders;
• Relevant concomitant comorbidities;

Sponsors & Collaborators

• Ospedale Policlinico San Martino: lead
• Associazione Italiana per la Ricerca sul Cancro: collaborator
• Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente: collaborator
• Bayer: collaborator

Study Sites (1)

IRCCS Ospedale Policlinico San Martino

Genoa, Liguria, 16132, Italy

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

durvalumab; regorafenib

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Alberto Sobrero, MD

  OSPEDALE SAN MARTINO IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alberto Sobrero, MD

CONTACT

+39 010 555 4386; alberto.sobrero@hsanmartino.it

Alessandro Pastorino, MD

CONTACT

+39 010 555 4386; alessandro.pastorino@hsanmartino.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 19, 2022
• Study Start: March 2, 2022
• Primary Completion: March 2, 2024
• Study Completion: March 2, 2024
• Last Updated: May 17, 2023

Record last verified: 2023-05

Locations

IT (1)