The METIMMOX study - treatment with FLOX chemotherapy with the addition of immune therapy for patients with spread of cancer from the large bowel.
- Conditions
- Metastatic colorectal cancerTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-001845-29-NO
- Lead Sponsor
- Akershus University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
Patient has histologically verified colorectal cancer (CRC). Patient is ambulatory with Eastern Cooperative Oncology Group performance status 0 or 1. Patient is at least 18 years of age. Patient has measurable liver-metastatic CRC that can be biopsied. Patient has incurable cancer. Patient has not had previous systemic therapy for the metastatic disease. Patient is eligible for the Nordic FLOX regimen. Patient has the following laboratory values, as measured in serum/plasma within 2 weeks perior to study entry, indicative of adequate organ function:
oHemoglobin at least 10.0 g/dL.
oNeutrophils at least 1.5 x109/L (without current use of colonystimulating factors).
oPlatelets at least 100 x109/L.
oC-reactive protein less than 60 mg/L.
oAST/ALT no higher than 5xULN (an eligible patient has metastatic disease in the liver).
oBilirubin no higher than 2xULN (an eligible patient has metastatic disease in the liver).
oAlbumin no lower than 30 g/L.
oINR within normal level.
oCreatinine no higher than 1.5xULN.
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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
Patient has potentially resectable metastatic disease. Patient is eligible for a first-line systemic regimen that does not contain oxaliplatin. Patient is eligible for a first-line regimen that must contain an inhibitor of EGFR or angiogenesis. Patient is eligible for a triplet chemotherapy regimen. Patient has primary tumor with BRAF mutation. Patient has metastatic disease to lungs as the sole site. Patient has untreated or symptomatic brain metastasis (patient must be symptom-free without the use of corticosteroids). Patient experiences a period of less than 12 months since discontinuation of adjuvant chemotherapy. Patient is ineligible for full chemotherapy doses (100% doses) at start of study treatment. Patient has had radiation therapy within 4 weeks of start of study treatment. Patient has a nervous system disorder worse than CTCAE grade 1. Patient has any medical condition that will preclude him/her from cancer immune-modulating therapy. Patient with current or prior use of immunosuppressive medication within 28 days before the first dose of study therapy, with the exceptions of intranasal corticosteroids or systemic corticosteroids at physiological doses that do not exceed 10mg/day of prednisone or an equivalent corticosteroid. Patient has undergone treatment with any investigational medicinal product that may interfere with the study treatment within 4 weeks prior to first administration of study drug. Patient has history of other prior malignancy, with the exception of curatively treated basal cell or squamous cell carcinoma of the skin, cervical cancer stage IB, and stage I prostate cancer considered not necessary to treat. Patient has significant cardiac, pulmonary, or other medical illness that would limit activity of daily life or survival. Patient is pregnant or breastfeeding. Patient has any other reason, in the opinion of Clinical Investigator, not to participate in the study.
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