2025-521941-25-00招募中2 期
Ipilimumab and nivolumab plus temozolomide and capecitabine for patients with chemo-refractory pMMR, MGMT silenced metastatic colorectal cancer: The MAYA2 trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 165
- 试验地点
- 3
- 主要终点
- Disease control rate (DCR) (complete response (CR), PR, or SD) evaluated by a CT scan 16 weeks after initiation of TemCap.
研究概览
简要总结
The main objective of the study is to investigate the possibility of making immunotherapy, a new and effective treatment, usually reserved for a few percent of patients with specific genomic profiles, available for a greater amount of patients with mCRC in later lines of therapy, and to investigate specific biomarkers predictive for treatment response.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent according to ethics committee requirements
- •Age ≥18 years
- •Metastatic or non-resectable adenocarcinoma of the colon or rectum
- •MSS or pMMR confirmed locally by PCR or IHC, respectively
- •MGMT promoter methylation confirmed by PCR and IHC in solid tumor tissue
- •Prior therapy with oxaliplatin, irinotecan and fluoropyrimidin based chemotherapy (or intolerance to these). Prior cetuximab, panitumumab, bevacizumab, aflibercept, regorafenib or trifluridine/tipiracil is allowed but not mandatory.
- •ECOG performance status 0-1
- •Woman of childbearing potential must have been tested negative in a serum pregnancy test within 5 days prior to randomization. Fertile patients must agree to use a highly effective method of birth control (see appendix 2 – highly effective methods of contraception) during the study and for six months after the discontinuation of study medication.
- •Adequate bone marrow function and organ function: a. Absolute neutrophil count (ANC) > 1.5 x 109/l and platelets (pl) > 100 x 109/l b. Serum bilirubin < 1.5 × upper limit of normal (ULN); and AST/ALT < 2.5 × ULN (or < 5 × ULN in patients with liver metastases). c. Estimated (eGFR) or measured glomerular filtration rate (GFR) > 50 ml/min
排除标准
- •Any condition requiring a daily dose of more than 10 mg prednisolone (or any other corticosteroid of equivalent strength), or any other immunosupressant, e.g. but not limited to mycophenolate and anti-TNF agents.
- •Clinically significant cardiovascular disease, such as recent cerebrovascular accidents or myocardial infarction within 6 months of study enrollment, unstable angina, New York Heart Association (NYHA) Functional Classification Grade II or higher congestive heart failure, or severe uncontrolled cardiac arrhythmia.
- •Symptomatic brain metastases, or radiographic evidence of progression of known brain metastases within 8 weeks of entry in the study.
- •Pregnancy or breastfeeding
- •Any other condition or therapy, which in the investigators opinion may pose a risk to the patient or interfere with the study objectives.
- •History of autoimmune disease. Exceptions are adequately controlled autoimmune induced hypothyroidism, type 1 diabetes. Psoriasis or vitiligo are allowed as long as no systemic treatment is required.
- •Significant co-morbidity that the investigator considers inadequately controlled, or that would make the patient unable to tolerate study treatment.
- •Patients with known hypersensitivity to any of the study drugs or their excipients.
- •Inability to swallow tablets.
- •Malabsorption, significant bowel resection, or any other disease that would significantly inhibit bowel absorption.
- •Previous treatment with temozolomide.
- •Concurrent secondary active malignancy.
- •Patients with either homozygosity or compound heterozygosity for multiple gene variants of dihydropyrimidine dehydrogenase (DPD), leading to a significant reduction in 5-FU metabolism do not meet eligibility criteria. However, those with decreased DPD activity who have previously tolerated 5-FU treatment can participate with capecitabine dosed according to the latest tolerated dose of capecitabine or 5FU.
结局指标
主要结局
Disease control rate (DCR) (complete response (CR), PR, or SD) evaluated by a CT scan 16 weeks after initiation of TemCap.
Disease control rate (DCR) (complete response (CR), PR, or SD) evaluated by a CT scan 16 weeks after initiation of TemCap.
次要结局
- 1. PFS for patients initiating TemCap and for patients initiating TemCap with ipi-nivo
- 2. OS for patients initiating TemCap and for patients initiating TemCap with ipi-nivo
- 3. ORR according to RECIST 1.1 criteria
- 4. Safety and tolerability of the combination of ipi-nivo and TemCap
- 5. Quality of life measured by the EORCT QLQ-C30 questionnaire
研究者
Kristian Krejberg
Scientific
Odense University Hospital
研究点 (3)
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