stage IV colorectal cancer patients with no evidence of disease (NED) MedDRA version: 21.0 Level: LLT Classification code 10001172 Term: Adenocarcinoma of colon stage IV System Organ Class: 100000004864
Conditions
Interventions
Product Name: DURVALUMAB
Product Code: [EMEA/H/C/4771]
Pharmaceutical Form: Concentrate for solution for injection/infusion
CAS Number: 1428935-60-7
Current Sponsor code: MEDI4736
Concentration unit:
Sponsors
IRCCS-A.O.U. SAN MARTINO-IST
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed ICF, after oral as well as written information; 2. = 18 years; 3. Body weight >30 kg 4. Histologically confirmed diagnosis of colorectal adenocarcinoma; 5. 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; 6. 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; 7. NED state ascertained by means of CT scan and/or PET scan and/or MRI scan; 8. ECOG Performance Status =65 years) yes F.1.3.1 Number of subjects for this age range 85
Exclusion criteria
Exclusion criteria: 1. History of another primary malignancy within the last 5 years 2. Patients with microsatellite instability (MSI) or DNA Mismatch Repair Deficiency (dMMR) are not allowed. 3. Any form of systemic disease that, in the opinion of the Investigator, would make the subject unsuitable for the study 4. Adeguate Serum Creatinine 5. Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control 6. Any condition that, in the opinion of the investigator, would interfere with evaluation of the study drug or interpretation of patient safety or study results 7. Participation in another clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Disease Free Survival (DFS);Secondary Objective: ¿18-months Disease-Free Survival (DFS) ¿Adverse events and Toxicity ¿Overall Survival (OS) ¿Compliance to the experimental treatment;Primary end point(s): Disease Free Survival (DFS);Timepoint(s) of evaluation of this end point: the following condition will be considered DFS event: Two consecutive increases in CEA levels above upper limit level (time gap decided by the clinical investigator). | — |
Countries
Italy
Contacts
Public ContactGestione del Regolatorio: inserimen
Fondazione GISCAD
Outcome results
None listed