Trials Sponsors Conditions Drugs Pricing

Conditions

Colorectal Cancer Stage IV No Evidence of Disease State Stage IV colorectal cancer patients with no evidence of disease (NED)

Keywords

NED stateadjuvanttyrosine kinase inhibitorsimmunotherapy

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

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 infusionDrug: 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 infusionDrug

MEDI4736

Also known as: Imfinzi

DURVALUMAB + REGORAFENIB

Regorafenib 30 mg capsulesDrug

BAY73-4506

Also known as: Stivarga

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product
BAY 734506
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry record
Formulated product
IMFINZI 50 mg/mL concentrate for solution for infusion.
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
View registry record
Formulated product
Regorafenib 30 mg capsules
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
View registry record

Ingredients named in source formulations

The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.

BAY 734506
Named ingredient: regorafenib
View registry record
IMFINZI 50 mg/mL concentrate for solution for infusion.
Named ingredient: durvalumab
View registry record
Regorafenib 30 mg capsules
Named ingredient: regorafenib
View registry record

Eligibility Criteria

Age18 Years+

Sexall(Gender-based eligibility)

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

≥ 18 years; ECOG PS 0-1;
Body weight \>30 kg;

Sponsors & Collaborators

Associazione Italiana per la Ricerca sul Cancro
Othercollaborator
Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente
Othercollaborator

Study Sites (1)

IRCCS Ospedale Policlinico San Martino

Genoa, Liguria, 16132, Italy

RECRUITING

Alberto Sobrero, MDCONTACT+39 010 555 4386 alberto.sobrero@hsanmartino.it

Alessandro Pastorino, MDCONTACT+39 010 555 4386 alessandro.pastorino@hsanmartino.it

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

durvalumabregorafenib

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal 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

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

Actual (reported)

Primary Completion

March 2, 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

DURVALUMAB + REGORAFENIB

CONTROL ARM

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source records

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

DURVALUMAB + REGORAFENIB

CONTROL ARM

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source records

Documents

Locations