Metastatic Colorectal Adenocarcinoma MedDRA version: 9.1 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer
Conditions
Interventions
Product Name: TroVax
Product Code: SAR109659
Pharmaceutical Form: Powder for solution for injection
Current Sponsor code: SAR109659
Othe
Sponsors
Oxford BioMedica
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with histology/cytology confirmed colorectal adenocarcinoma - Metastatic colorectal cancer - No prior palliative chemotherapy - Patient's informed consent obtained, signed and dated. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: * Related to study methodology - Age 2 - (Neo)Adjuvant chemotherapy if 1.0 x ULN, except in case of creatinine > 1.0 x ULN and = 1.5 x ULN if calculated creatinine clearance = 60 mL/min - Any other active illness such as uncontrolled cardiac disease or hypertension, uncontrolled diabetes that would preclude safe administration of study therapy at the time of randomization: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft surgery, clinically symptomatic and uncontrolled cardiovascular disease or clinically significant arrhythmias (grade 3-4) * Related to TroVax - Lymphocytes < 1 x 10e9/L - Serious infection within 28 days prior to randomization - History of hypersensitivity to vaccinia vaccination - Known hypersensitivity to egg protein or neomycin - Known positive test to human immunodeficiency virus (HIV) or any congenial or acquired immune deficiency, or active and/or requiring treatment hepatitis B or C - Active eczema with lesions on the skin - Prior history of organ transplantation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To compare overall survival (OS) with TroVax vs. Placebo in patients with metastatic colorectal cancer receiving chemo-based therapy in first line treatment.; Secondary Objective: - To compare PFS between TroVax vs. Placebo arms. - To compare Objective Response rate (ORR) between TroVax vs. Placebo arms. - To assess the safety and tolerability of TroVax and Placebo arms. + Exploratory: - To assess the immunologic response (5T4 and MVA antibody titers and T-cells) in a subgroup of this patient population (in selected centers). ;Primary end point(s): The primary efficacy endpoint is overall survival (OS) defined as the time interval from the date of randomization to the date of death due to any cause. In absense of confirmation of death survival time will be censored at the earlier of the last date the patient is known to be alive and the study cut-off date. | — |
Countries
Germany, Spain, United Kingdom
Outcome results
None listed