A Study of Novel Oncology Therapies in Combination with FOLFOX and Bevacizumab in Metastatic Microsatellite-Stable Colorectal Cancer
- Conditions
- Metastatic Microsatellite-Stable Colorectal CancerMedDRA version: 21.0 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2019-000974-44-ES
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 114
• Written informed consent and any locally required authorization obtained from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
• Age = 18 years at the time of screening.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Patients must have histologic documentation of advanced or metastatic colorectal cancer and:
- A documented mutation test during screening and confirmed tumor locations from disease assessment for enrollment.
- Patients must NOT have defective DNA mismatch repair (microsatellite instability) as documented by testing.
- Patients must not have received any prior systemic therapy for recurrent/metastatic disease (prior adjuvant chemotherapy or radio-chemotherapy is acceptable so long as progression was not within 6 months of completing the adjuvant regimen).
• Patients must have at least one lesion that is measurable by RECIST v1.1 (Eisenhauer et al, 2009).
• Patients must have adequate organ function.
• Patients with medical conditions requiring systemic anticoagulation (eg, atrial fibrillation) are eligible provided that both of the following criteria are met:
- The patient has an in-range international normalized ratio (INR) on a stable dose of oral anticoagulant or be on a stable dose of low molecular weight heparin.
- The patient has no active bleeding or pathological condition that carries a high risk of bleeding.
• Body weight > 35 kg.
• Adequate method of contraception per protocol.
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 53
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 53
• History of allogeneic organ transplantation.
• Active or prior documented autoimmune disorders within the past 5 years
• History of venous thrombosis within the past 3 months
• Cardiovascular criteria:
- Presence of acute coronary syndrome including myocardial infarction or unstable angina pectoris, other arterial thrombotic event including cerebrovascular accident or transient ischemic attack or stroke within the past 6 months.
- New York Heart Association (NYHA) class II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, or uncontrolled hypertension.
- History of hypertensive crisis/hypertensive encephalopathy within the past 6 months
• Mean QT interval corrected for heart rate using Fridericia’s formula (QTcF) = 470 ms
• No significant history of bleeding events or gastrointestinal perforation
• Uncontrolled intercurrent illness
• History of another primary malignancy except for:
- Malignancy treated with curative intent and with no known active disease = 5 years of low potential risk for recurrence.
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
- Adequately treated carcinoma in situ without evidence of disease.
• History of active primary immunodeficiency
• Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus.
• Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
• Any unresolved toxicity NCI CTCAE Grade > 1 from previous anticancer therapy.
• History of leptomeningeal disease or cord compression.
• Untreated central nervous system (CNS) metastases
• Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication.
• Known dihydropyrimidine dehydrogenase (DPD) deficiency.
• Prior immunotherapy or anti-angiogenics.
• Receipt of live attenuated vaccine within the past 30 days.
• Major surgical procedure, open biopsy, or significant traumatic injury within the past 28 days.
• Current or prior use of immunosuppressive medication within the past 14 days, with exceptions per protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method