EUCTR2017-000086-74-BE进行中（未招募）1 期
A pilot study of personalized biomarker-based treatment strategy or immunotherapy in patients with recurrent/metastatic squamous cell carcinoma of the head and neck UPSTREAM
European Organisation for Research and Treatment of Cancer (EORTC)0 个研究点目标入组 340 人开始时间: 2017年6月26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
- 340
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
- •Histologically confirmed recurrent and/or metastatic SCCHN of the oral cavity, oropharynx, hypopharynx or larynx
- •At least one measurable lesion by MRI or CT-scan according to RECIST 1.1
- •Progressive disease after platinum-based chemotherapy with or without cetuximab Note: Patients from France, Germany, Italy and Spain without contra-indication for immunotherapy, must have been treated with anti-PD1/PD-L1 therapies before inclusion, as per standard of care.
- •ECOG performance status 0-1 with a life expectancy of at least 12 weeks
- •Tumor core biopsy from any accessible tumor at the recurrent or metastatic site available for central testing
- •Adequate organ function, evaluated within 14 days prior to cohort allocation:
- •Hemoglobin = 9 g/100 ml
- •Neutrophils = 1,500/mm3
- •Platelets = 100,000/mm3
- •Total bilirubin <1.5 times the ULN
- •Serum ALT and AST = 2.5 x ULN for age
- •Adequate renal function
- •INR or PT must be within the normal ranges as per institution's standard
- •Patients receiving anticoagulant therapy are allowed to participate
- •Clinically normal cardiac function based on -left ventricular ejection fraction (= 50%) as assessed either by multi-gated acquisition scan or cardiac ultrasound and 12 lead ECG without clinically relevant abnormalities.
- •Patients = 18 years old and must be able to give written informed consent.
- •Women of child-bearing potential must have a negative pregnancy test.
- •Patients of childbearing / reproductive potential must agree to use highly effective methods of contraception based on the CTFG guidance as of registration and up to 6 months after the last treatment dose.
- •Female subjects who are breast feeding should agree to discontinue nursing prior to the first dose of study treatment and up to 6 months after the last study treatment.
- •Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
- •- Cohort I1
- •If the patient is pretreated with prior PD(L)1 compound blocker, criteria on protocol section 3.1.2.1 must be met.
- •- Cohort I2
- •Pretreated patients with prior PD(L)1 compound blocker meeting all the criteria on protocol section 3.1.2.2.
- •- Cohort B1
- •Confirmed p16 negative immunohistochemistry (p16 positive is defined as H-score = 210) on the fresh biopsy
- •Wild type for the known activating mutations in KRAS, NRAS and HRAS
- •One of the specific criteria mentioned on protocol section 3.1.2.3 has to be fulfilled.
- •- Cohort B2
- •Confirmed p16 negative immunohistochemistry on the fresh biopsy
- •Cetuximab-naïve patient
- •Wild type for the known activating/damaging mutations in KRAS, NRAS and HRAS
- •- Cohort B3
- •Confirmed p16 negative immunohistochemistry on the fresh biopsy
- •Cyclin D1 amplification
- •- Cohorts B4 and B5
- •Participant receiving corticosteroids may continue as long as their dose is stable for at least 4 weeks prior to initiating protocol therapy
- •Participant must agree to not donate blood during the study and for 90 days after the last dose of study treatment
- •Palliative radiation therapy will be allowed as long as it is > 1 week from cohort allocation, or > 2 weeks from cohort allocation for radiation encompassing > 20% of the bone marrow
- •Total Bilirubin =1.5 times the ULN
- •Serum creatinine = 1.5 x ULN or calculated creatinine clearance = 50 mL/min using the Cockcroft-Gault equation
- •- Cohort B4
- •Confirmed p16 negative immunohistochemistry on the fresh biopsy
排除标准
- •Unresolved and significant toxicity CTCAE version 4.03 grade = 2 from previous anticancer therapy other than alopecia
- •History of any of the cardiovascular conditions within 6 months prior to registration
- •Nasopharynx and sino-nasal tumor
- •Surgery or investigational drugs or chemotherapy or other anticancer therapy within 3 weeks before cohort allocation.
- •Known untreated and uncontrolled brain metastases or leptomeningeal carcinomatosis.
- •Known diagnosis of immune deficiency or HIV
- •Active Hepatitis B or C or pre-existing liver cirrhosis
- •History of Extensive disseminated/bilateral or known presence of IDL, but not history of prior radiation pneumonitis.
- •Other uncontrolled active illnesses or nonmalignant systemic disease
- •Any psychiatric, psychological, familial, sociological or geographical condition
- •Any malignancy within the last 3 years prior to registration
- •- Cohort I1
- •Systemic trt with steroids or other immunosuppressive agents within 7d prior to cohort allocation
- •History of allograft transplantation
- •Active auto-immune disease/inflammatory disorders treated with systemic immunosuppressive drugs within the last 3 months or history of clinically severe auto-immune disease /inflammatory disorders
- •Trt with cytokines or growth factors
- •Known hypersensitivity to monalizumab or its excipients
- •Receipt of live, attenuated vaccine within 30 days prior to registration
- •- Cohort I2
- •The same listed for cohort I1, plus:
- •More than 3 lines of systemic trt in the recurrent metastatic setting
- •History of immune related disease without active immune related diseases in the last 5 years
- •Immune related diseases
- •Trt. with cytokines or growth factors
- •Any chronic skin condition that requires systemic therapy
- •Requiring therapeutic anticoagulation and irreversible platelet inhibitors
- •Symptoms of spinal cord compression at randomization
- •Known hypersensitivity to monalizumab or durvalumab or their excipients
- •- Cohort B1 and B2
- •Patients with hereditary conditions of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •Unresolved skin toxicities CTCAE v4.03 grade >1
- •Trt. with any of the prohibited concomitant medications related to afatinib that cannot be stopped at the time of trial participation
- •Significant or recent acute gastrointestinal disorders with diarrhea as major symptom
- •Any of the following additional gastrointestinal disorders associated with high risk of perforation
- •Known hypersensitivity to afatinib or the excipients of any of the trial drugs
- •- Cohort B3
- •Food or drugs that are known to be CYP3A4 inhibitors or inducers related to palbociclib
- •Drugs known to prolong the QT interval
- •Uncontrolled electrolyte disorders that can compound the effects of a QTc-prolonging drug
- •Prior radiotherapy to 25% of bone marrow
- •Significant acute GI disorders with diarrhea as major symptom
- •Any previous trt with another CDK4/6 inhibitor
- •Known hypersensitivity to palbociclib and its excipients
- •- Cohort B4 and B5
- •Transfusion < 4 weeks prior to cohort allocation
- •Colony-stimulating factors within 4 weeks prior cohort allocation
- •Any known grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted > 4 weeks
- •Any known history of MDS or AML
- •Inability to swallow and using a feeding tube
- •Active GI disease or other malabsorption syndromes impacting drug absorption
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研究者
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