EUCTR2018-002010-12-DE进行中（未招募）1 期
Avelumab added to FOLFIRI plus Cetuximab followed by Avelumab maintenance in patients with previously untreated RAS/BRAF wild-type metastatic colorectal cancer - The phase II FIRE-6-Avelumab study - AIO KRK-0118/FIRE-6
Klinikum der Ludwig-Maximilians-Universität München - Klinikum Großhadern (vertreten durch den kaufmännischen Direktor)0 个研究点目标入组 55 人开始时间: 2019年1月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 55
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Histologically confirmed, UICC stage IV adenocarcinoma of the colon or rectum with metastases (mCRC), metastases primarily non resectable
- •or surgery refused by the patient
- •2. RAS wild-type tumour status (KRAS and NRAS, exon 2, 3, 4) and BRAF wild-type tumour status (V600, exon 15) (proven in the primary
- •tumour or metastasis)
- •3. Adult patients = 18 years
- •4. ECOG performance status 0-1
- •5. Patients suitable for chemotherapy administration
- •6. Patient's written declaration of consent obtained
- •7. Estimated life expectancy > 3 months
- •8. Presence of at least one measurable reference lesion according to the RECIST v1.1 criteria
- •9. Tumour tissue available for molecular and genetic profiling regarding BRAF/RAS mutation status and MSI Status
- •10. Females of childbearing potential (FCBPs) must agree to use highly effective contraceptive measures (Pearl index <1) or practice true abstinence from any heterosexual intercourse (true abstinence is acceptable if this is in line with the patient’s preferred and usual lifestyle) for the duration of study treatment and at least 6 months after the last study treatment. A woman will be considered as being of childbearing potential unless she is at least 50 years old and has gone through menopause for at least 2 years or has been surgically sterilised.
- •11. Males must agree to use condoms or practice true abstinence from any heterosexual intercourse (true abstinence is acceptable if this is in line
- •with the patient’s preferred and usual lifestyle) for the duration of study treatment and at least 6 months after the last study treatment. Male
- •patients must refrain from donating sperm during the study until 6 months after the administration of the last study medication.
- •12. Adequate bone marrow function:
- •a) Leukocytes = 3.0 x 109/L with neutrophils = 1.5 x 109/L
- •b) Thrombocytes = 100 x 109/L
- •c) Haemoglobin = 5.6 mmol/L (equivalent to 9 g/dL)
- •13. Adequate hepatic function:
- •a) Serum bilirubin = 1.5 x upper limit of normal (ULN)
- •b) ALT and AST = 2.5 x ULN (in the presence of hepatic metastases, ALT and AST = 5 x ULN)
- •c) INR < 1.5 and aPTT < 1.5 x ULN (patients without anticoagulation). Therapeutic anticoagulation is allowed if INR and aPTT have remained stable within the therapeutic range for at least 2 weeks.
- •14. Adequate renal function: Creatinine clearance (calculated according to Cockcroft and Gault) = 50 mL/min
- •15. Adequate cardiac function: ECG and echocardiogram with a LVEF of = 55%
- •16. No previous chemotherapy for metastatic disease. Patient with need of immediate treatment (high tumour load, symptoms) may have received
- •one application of FOLFIRI prior to study entry.
- •17. Time interval since last administration of any previous neoadjuvant/adjuvant chemotherapy or radiochemotherapy of the primary tumour in curative treatment intention = 6 months.
- •18. Any relevant toxicities of prior treatments must have resolved
- •19. Patient covered by health insurance
- •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
排除标准
- •1. Proof of a RAS mutation (KRAS or NRAS, exons 2, 3, 4) or BRAF mutation (V600 in exon 15) in the tumour (proven in primary tumour
- •or metastasis) or absence of testing for RAS or BRAF mutations
- •2. Primarily resect metastases and the patient wishes for resection
- •3. = Grade II heart failure (NYHA classif)
- •4. Myocardial infarct, balloon angioplasty (PTCA) with or without stenting + cerebral vascular accident/stroke within the past 12 months before start of study treatm, unstable angina pectoris, serious cardiac arrhythmia according to investigator’s judgem. requiring medic.
- •5. Pre-existing pulmonary fibrosis or immune pneumonitis
- •6. Active autoimmune disease that might be negatively affected by an immune checkpoint inhibitor. Patients diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosup. treatment are eligible.
- •7. Prior organ transpl., incl allogeneic stem cell transpl.
- •8. Current use of immunosuppressive medi, except for the following:
- •a) Intranasal, inhaled, topical steroids, or local steroid inject (e.g., intra-articular inject);
- •b) System corticosteroids at physiologic doses = 10 mg/day of prednisone or equivalent;
- •c) Steroids as premedic. for hypersens reactions (e.g., CT scan premedi).
- •9. Pregnancy (absence of pregnancy to be ascertained by a negative ß-HCG test) or breast feeding
- •10. Medi or psychol impairments assoc. with restricted ability to give consent or not allowing conduct of the study
- •11. Add cancer treatm (chemoth., radiation, immunoth or hormone treatm.) during the study treatm in first-line
- •(treatm that are conducted as part of an anthroposophic or homeopathic treatm approach, e.g. mistletoe therapy do not represent an excl.cr.)
- •12. Previous chemoth. for the Color. cancer with the exception of adjuvant treatm., compl at least 6 months bef. entering the study
- •13. Adv. drug reaction > NCI CTCAE Grade1 that has not yet resolved, attributed to a previous treatm or measure for treatm of the CRC. However, alopecia (all grades) and oxaliplatin-induced neurotox = grade 2 are acceptable.
- •14. Participat in a clinic study or experim. drug treatm within 30 days prior to study incl. or within a period of 5 half-lives of the
- •substances admin. in a clinical study or during an experimental drug treatm prior to incl. in the study, depending on which
- •period is longest or simultaneous participation in another study while taking part in the study
- •15. Known hypersensitivity or allergic react to any of the following substances: folinic acid, 5-FU, irinotecan, cetuximab,
- •avelumab and chemically related substances and/or hypersens to any of the components in the formulations of the aforementioned
- •subst, incl known hypersensitivity reactions to monoclonal antibodies NCI CTCAE Grade = 3.
- •16. Known hypersensitivity to Chinese hamster ovary cell (CHO) – cellular products or other recombinant human or humanised monocl antibodies
- •17. Patients with known brain metastases. In case of clinical suspicion of brain metastasis a cranial MRI or CT must be performed to rule out brain metastasis bef. study inclus.
- •18. History of acute or subacute intestinal occlusion, inflammatory bowel disease, immune colitis or chronic diarrhoea
- •19. Symptomatic peritoneal carcinosis
- •20. Severe, non-healing wounds, ulcers or bone fractures
- •21. Patients with act. infect requiring syst. therapy
- •22. Known history of testing positive for HIV or known acquired immunodeficiency syndr.
- •23. Active or chronic Hepatitis B virus (HBV) or hepa
研究者
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