Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
182
Countries
1
Sites
12
Stage IV colorectal cancer patients with no evidence of disease (NED)
Disease Free Survival (DFS)
Key facts
- Sponsor
- IRCCS Ospedale Policlinico San Martino, IRCCS Ospedale Policlinico San Martino
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 20 Oct 2021 → ongoing
- Decision date (initial)
- 2024-10-28
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Fondazione AIRC per la Ricerca sul Cancro ETS · Bayer S.p.A. · Astra Zeneca S.p.A
External identifiers
- EU CT number
- 2024-518217-26-00
- EudraCT number
- 2020-001588-10
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
Disease Free Survival (DFS)
Secondary objectives 4
- 18-months disease free survival
- Adverse events and Toxicity
- Overall Survival (OS)
- Compliance to experimental treatment
Conditions and MedDRA coding
Stage IV colorectal cancer patients with no evidence of disease (NED)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10001172 | Adenocarcinoma of colon stage IV | 10029104 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Adjuvant Therapy in stage IV colorectal cancer patients NED This project is a randomized, open-label, multicenter study. All eligible patients, after completion of locoregional treatment to render them disease free, will be randomized to experimental treatment (adjuvant regorafenib plus durvalumab) or no further treatment (observation). Randomization is 1:1. Patients randomized to the experimental arm will receive up to 1 year of regorafenib + durvalumab. Patients randomized to the control arm will receive no further treatment. Patients in the control arm will be offered the possibility to crossover to regorafenib plus durvalumab upon relapse.
|
Randomised Controlled | None | Experimental arm: Regorafenib 90mg d1-21 q28 + Durvalumab 1500mg (Q4W) up to 1 year Control arm: No treatment. Crossover to Regorafenib + Durvalumab upon relapse |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- ≥ 18 years
- 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
- NED state ascertained by means of CT scan and/or PET scan and/or MRI scan
- 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 or those who achieved complete response on systemic therapies are still eligible, provided they are randomized within 4 weeks since the last chemotherapy cycle
Exclusion criteria 5
- Prior randomisation or treatment in a previous durvalumab clinical study regardless of treatment arm assignment
- Patients with microsatellite instability (MSI) or DNA Mismatch Repair Deficiency (dMMR) are not allowed
- Any form of systemic disease that, in the opinion of the Investigator, would make the subject unsuitable for the study (including autoimmunity) or would prevent compliance with the study protocol
- Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
- Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Disease-Free Survival (DFS)
Secondary endpoints 4
- ● 18-months Disease-Free Survival (DFS)
- ● Adverse events and Toxicity
- ● Overall Survival (OS)
- ● Compliance to the experimental treatment
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
IMFINZI 50 mg/mL concentrate for solution for infusion.
PRD6651398 · Product
- Active substance
- Durvalumab
- Substance synonyms
- MEDI4736
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 1500 mg milligram(s)
- Max total dose
- 1500 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FF03 — -
- Marketing authorisation
- EU/1/18/1322/001
- MA holder
- ASTRAZENECA AB
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD10079495 · Product
- Active substance
- Regorafenib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 90 mg milligram(s)
- Max total dose
- 1890 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- BAYER AG
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
IRCCS Ospedale Policlinico San Martino
- Sponsor organisation
- IRCCS Ospedale Policlinico San Martino
- Address
- Largo Rosanna Benzi 10
- City
- Genoa
- Postcode
- 16132
- Country
- Italy
Scientific contact point
- Organisation
- IRCCS Ospedale Policlinico San Martino
- Contact name
- Alessandro Pastorino
Public contact point
- Organisation
- IRCCS Ospedale Policlinico San Martino
- Contact name
- Alessandro Pastorino
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Istituto Di Ricerche Farmacologiche Mario Negri ORG-100006092
|
Milan, Italy | Code 10, Other, Data management, E-data capture, Code 8 |
IRCCS Ospedale Policlinico San Martino
- Sponsor organisation
- IRCCS Ospedale Policlinico San Martino
- Address
- Largo Rosanna Benzi 10
- City
- Genoa
- Postcode
- 16132
- Country
- Italy
Locations
1 EU/EEA country · 12 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruitment ended | 182 | 12 |
| Rest of world | — | 0 | — |
Investigational sites
Istituto Tumori Bari Giovanni Paolo II
SC Oncologia Medica, Viale Orazio Flacco 65, 70124, Bari
Azienda Sanitaria Universitaria Friuli Centrale
SOC Oncologia, Piazzale Santa Maria Della Misericordia 15, 33100, Udine
Istituto Oncologico Veneto
UOC Oncologia 1, Via Gattamelata 64, 35128, Padova
Azienda Ospedaliero Universitaria Pisana
UO Oncologia Medica 2, Via Roma 67, 56126, Pisa
Azienda Unita Locale Socio Sanitaria N. 1 Dolomiti
UO Oncologia Medica, Via Feltre 57, 32100, Belluno
Azienda Ulss 9 Scaligera
UO Oncologia Medica, Via Carlo Gianella 1, 37045, Legnago
Azienda Ospedaliera Regionale San Carlo
UOC Oncologia Medica, Via Potito Petrone, 85100, Potenza
IRCCS Ospedale Policlinico San Martino
UO Oncologia Medica 1, Largo Rosanna Benzi 10, 16132, Genoa
Azienda Sanitaria Locale Napoli 1 Centro
UOC Oncologia Medica, Via Enrico Russo 1, 80147, Naples
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Oncologia Medica, Largo Francesco Vito 1, 00168, Rome
Fondazione IRCCS San Gerardo Dei Tintori
SC Oncologia, Via Giovanni Battista Pergolesi 33, 20900, Monza
Cliniche Gavazzeni S.p.A.
UO Oncologia Medica, Via Mauro Gavazzeni 21, 24125, Bergamo
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Italy | 2021-10-20 | 2022-03-04 | 2025-05-31 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ Protocol 2024-518217-26-00 redacted | 2 |
| Recruitment arrangements (for publication) | K1_ recruitment arrangment_ blank doc | NA |
| Subject information and informed consent form (for publication) | L1_ Data protection ICF | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adult | 2 |
| Subject information and informed consent form (for publication) | L2_ other subject information MM letter | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Regorafenib | NA |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG 2024-518217-26-00 blank doc | NA |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_IT 2024-518217-26-00 redacted | 2 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-26 | Italy | Acceptable 2024-10-23
|
2024-10-28 |