Colorectal Cancer Stage IVPhase 2VIVANCT05382741
Adjuvant Durvalumab Plus Regorafenib vs Untreated Control in Stage IV Colorectal Cancer Patients With no Evidence of Disease (NED): VIVA Trial
A Phase 2 study testing Durvalumab Injection for intravenous use 500 mg vial solution for infusion and Regorafenib 30 mg capsules in people with Colorectal Cancer Stage IV and No Evidence of Disease State, run by Ospedale Policlinico San Martino at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Stage IV, No Evidence of Disease State
- What is being tested?
- Durvalumab Injection for intravenous use 500 mg vial solution for infusion and Regorafenib 30 mg capsules
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteItaly
- Study dates
- 2 Mar 2022to 2 Mar 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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;
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- Life expectancy of at least 12 weeks;
- CEA within normal limits;
- No residual toxicity from previous chemotherapy;
- Adequate organ function;
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale Policlinico San Martino
Genoa, Liguria, 16132
Alberto Sobrero, MD, +39 010 555 4386, alberto.sobrero@hsanmartino.it
Alessandro Pastorino, MD, +39 010 555 4386, alessandro.pastorino@hsanmartino.it
About this study
Official title: Study of Adjuvant Durvalumab (MEDI4736) Plus Regorafenib vs Untreated Control in Stage IV Colorectal Cancer Patients With no Evidence of Disease (NED): VIVA Trial
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:
Read more
- R0 resection for surgery,
- the complete ablation defect covering the lesion on CT scan for radiofrequency,
- the erogation of ≥ 60 Gy for stereotactic radiotherapy,
- 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.
Read the 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.
- Being tested
- Durvalumab Injection for intravenous use 500 mg vial solution for infusion, Regorafenib 30 mg capsules
- Keywords
- NED state, adjuvant, tyrosine kinase inhibitors, immunotherapy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Durvalumab Injection for intravenous use 500 mg vial solution for infusionDrug
Also called Imfinzi
MEDI4736
Regorafenib 30 mg capsulesDrug
Also called Stivarga
BAY73-4506
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: approximately 48 months
Secondary outcomes (3)
18 months - 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).
Measured: approximately 48 months
Overall Survival
Overall survival, defined as the time from the date of randomization to death due to any cause
Measured: approximately 48 months
Incidence of adverse events
An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Toxicity/adverse events are classified according to NCI CTCAE version 5.0.
Measured: approximately 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start2 Mar 2022
- Primary completion2 Mar 2024 (estimated)
- Study completion2 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer Stage IVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 182 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale Policlinico San Martino
- Sponsor type
- University, hospital or other
- Collaborators
- Associazione Italiana per la Ricerca sul Cancro, Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente, Bayer
- Responsible party
- Sponsor
- Investigators
- Alberto Sobrero, MD, Principal investigator, OSPEDALE SAN MARTINO IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05382741
- Sponsor's protocol ID
- VIVA TRIAL
- Acronym
- VIVA
- Status last verified
- May 2023
- First submitted
- 10 May 2022
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Adjuvant Durvalumab (MEDI4736) Plus Regorafenib vs Untreated Control in Stage IV Colorectal Cancer Patients With no Evidence of Disease (NED): VIVA Trial
- ClinicalTrials.gov ID
- NCT05382741
- Acronym / sponsor ID
- VIVA / VIVA TRIAL
- Keywords
- NED state, adjuvant, tyrosine kinase inhibitors, immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 182 participants (estimated)
- Lead sponsor
- Ospedale Policlinico San MartinoUniversity, hospital or other
- Collaborators
- Associazione Italiana per la Ricerca sul Cancro, Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente, Bayer
- Study start
- 2 Mar 2022 (actual)
- Primary completion
- 2 Mar 2024 (estimated)
- Study completion
- 2 Mar 2024 (estimated)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- R0 resection for surgery,
- the complete ablation defect covering the lesion on CT scan for radiofrequency,
- the erogation of ≥ 60 Gy for stereotactic radiotherapy,
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DURVALUMAB + REGORAFENIB | Experimental | Drug: Durvalumab Injection for intravenous use 500 mg vial solution for infusion, Drug: Regorafenib 30 mg capsulesDurvalumab 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. |
| CONTROL ARM | No intervention | –Observation (follow-up). Crossover to the experimental arm is allowed in case of relapse. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ≥ 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;
Key exclusion criteria (4 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Durvalumab Injection for intravenous use 500 mg vial solution for infusionAlso: ImfinziMEDI4736 | Drug | DURVALUMAB + REGORAFENIB |
| Regorafenib 30 mg capsulesAlso: StivargaBAY73-4506 | Drug | DURVALUMAB + REGORAFENIB |
Primary outcome
Disease Free Survival
Time frame: approximately 48 months
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).
3 secondary outcomes
18 months - Disease Free Survival
Time frame: approximately 48 months
Overall Survival
Time frame: approximately 48 months
Incidence of adverse events
Time frame: approximately 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alberto Sobrero, MD principal investigator
OSPEDALE SAN MARTINO IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Durvalumab Injection for intravenous use 500 mg vial solution for infusion and Regorafenib 30 mg capsules in people with Colorectal Cancer Stage IV and No Evidence of Disease State, run by Ospedale Policlinico San Martino at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alberto Sobrero, MD (+39 010 555 4386, alberto.sobrero@hsanmartino.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Free Survival (time frame: approximately 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023.