Advanced colorectal cancer MedDRA version: 21.0 Level: PT Classification code 10052358 Term: Colorectal cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: OPDIVO - 10 MG/ML- CONCENTRATO PER SOLUZIONE PER INFUSIONE- USO ENDOVENOSO- FLACONCINO (VETRO)- 10 ML- 1 FLACONCINO
Product Name: Nivolumab
Product Code: [Nivolumab]
Pharmaceutical Form: S
Sponsors
GRUPPO ONCOLOGICO ITALIANO DI RICERCA CLINICA (GOIRC)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age = 18 years on day of signing informed consent. • Histologically confirmed metastatic CRC RAS/BRAF mutated. • Suitable for first line chemotherapy. • Life expectancy > 3 months. • At least one site of measurable disease per RECIST criteria. • Performance status of 0-1 on the ECOG Performance Scale. • Adequate organ function, all screening labs should be performed within 28 days of treatment initiation. • Availability of 1 tumor block at baseline. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 55 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: • Prior chemotherapy. • Systemic corticosteroids within 2 weeks of the first dose of nivolumab. • Diagnosis of immunodeficiency or patient who is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to the first dose of trial treatment. • Additional malignancy in the last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy. • Active and untreated brain (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are not using steroids for at least 7 days prior to trial treatment. • Evidence of interstitial lung disease, active non-infectious pneumonitis, or a history of grade 3 or greater pneumonitis. • Active infection requiring systemic therapy. • History of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies). • Active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected). • Live vaccine within 30 days prior to the first dose of trial treatment. • Women with a positive pregnancy test at enrollment or prior to administration of study medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To evaluate the efficacy and safety of the combined treatment, the time of progression and the duration of the treatment response and the quality of life of the patients. To evaluate the Tumor Mutation Burden , MSI status and the role of genetic and molecular pattern with patient’s outcome.;Main Objective: Evaluate the activity of Nivolumab in combination with FOLFOXIRI and bevacizumab.;Primary end point(s): To demonstrate that adding nivolumab to standard colorectal first line chemotherapy improves the Overall Response Rate as determinated by investigators using RECIST 1.1 criteria.;Timepoint(s) of evaluation of this end point: From the start of the study treatment until the end of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To evaluate the safety of the combination treatment with folfoxiri + bevacizumab + nivolumab. Safety assessments will include the incidence, nature, and severity of Adverse Events (AEs) and laboratory abnormalities graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v. 4.03.; To evaluate the efficacy in terms of overall survival (OS) defined as the time from start of study drug to the date of death from any cause.; To evaluate the Time To Progression (TTP) defined as the time between the date of start of study drug and the first date of documented progression, based on investigator assessment (as per RECIST 1.1 criteria), or death due to any cause, whichever occurs first.; To evaluate the duration of response defined as the time between the date of first evidence of response (SD/PR/CR) and the date of documented progression or death due to any cause, whichever occurs first.; To evaluate the quality of life of patients determinated with the EQ-5D questionnaire.; To evaluate the Tumor Mutation Burden , MSI status and the role of genetic and molecular pattern with patient’s outcome.;Timepoint(s) of evaluation of this end point: From the date the patient entered in the study until the end of the study.; From start of study drug to the date of death from any cause.; From the date of start of study drug to the first date of documented progression or to death due to any cause,; From the date of first evidence of response to the date of documented progression or to death due to any cause.; Quality of life will be assessed at baseline, every 4 weeks during treatment and at study discontinuation visit.; At the end of the study. | — |
Countries
Italy
Contacts
Public ContactServizio Informazione sulla Sperime
Pharmaceutical Development and Services srl
Outcome results
None listed