EUCTR2019-002986-36-IT进行中（未招募）1 期
A randomized, run-in, phase II study of nivolumab combined with ipilimumab and guadecitabine or nivolumab combined with ipilimumab in melanoma and NSCLC patients resistant to anti-PD-1/PD-L1 - NIBIT-ML-1
FONDAZIONE NIBIT NETWORK ITALIANO PER LA BIOTERAPIA DEI TUMORI0 个研究点目标入组 184 人开始时间: 2021年8月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 184
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
- •Signed Written Informed Consent
- •Willing and able to give written informed consent.
- •Target Population Subjects must fulfill all of the following inclusion criteria:
- •Men and women of and over 18 years old
- •1) Target Population Melanoma cohort A
- •a) Histologic diagnosis of malignant melanoma
- •b) Unresectable Stage III/Stage IV melanoma patients with resistance to anti-PD-1/PD-L1 and measurable lesions
- •by CT or MRI per iRECIST/RECIST criteria that can be amenable to biopsy
- •c) Only one line of immunotherapy for advanced (unresectable Stage III or Stage IV) disease with anti-PD-1/PDL1
- •and its combinations; if BRAF mutant one line of targeted therapy is allowed prior to anti-PD-1/PDL1therapy.
- •2) Target Population NSCLC cohort B
- •a) Histologic or cytologic diagnosis of NSCLC lacking EGFR-sensitizing mutation and/or ALK/ROS1
- •translocation.
- •b) Stage IV NSCLC patients with primary resistance to anti-PD-1/PD-L1 and measurable lesions by CT or MRI
- •per iRECIST/RECIST criteria that can be amenable to biopsy.
- •c) Only one line of immunotherapy for advanced (unresectable Stage III or Stage IV) disease with anti-PD-1/PDL1
- •or its combinations; one line of chemotherapy is allowed prior to anti-PD-1/PDL-1 therapy.
- •3) confirmed PD
- •4) 4 weeks or greater since last treatment and
- •5) Must have recovered from any acute toxicity associated with prior therapy
- •6) Life expectancy greater than 16 weeks
- •7) Subjects with adequate organ function defined as:
- •a) WBC =3500/uL
- •b) ANC =2000/uL
- •c) Platelets = 100 x 103/uL
- •d) Hemoglobin = 9 g/dL
- •e) Creatinine < or <= 2.5 x ULN AND creatinine clearance (CrCl) = 40 mL/min (if using the Cockcroft-Gault formula below):
- •Female CrCl = (140 - age in years) x weight in kg x 0.85
- •72 x serum creatinine in mg/dL
- •Male CrCl = (140 - age in years) x weight in kg x 1.00
- •72 x serum creatinine in mg/dL
- •- < or <= 2.5 x ULN for patients without liver metastasis
- •Nivolumab Ipilimumab Guadecitabine
- •NIBIT-ML-1 Clinical Protocol
- •- < or <= 5 x ULN for patients with liver metastasis
- •g) Bilirubin
- •- < or <= 3 x ULN for patients with liver metastasis
- •- <3.0 mg/mL for patients with Gilbert’s Syndrome
- •- 1.5 x ULN for patients without liver metastasis
- •8) Negative screening tests for HIV, HepB, and HepC. If positive results are not indicative of true active or chronic
- •infection, the patient can enter the study after discussion and agreement between the Investigator and the Medical Monitor.
- •9) Women of child-bearing potential must not be pregnant or breastfeeding, must have a negative pregnancy test at
- •Screening and all men must be practicing two medically acceptable methods of birth control. Men should not father a
- •child while receiving treatment with guadecitabine+ ipilimumab, and for 2 months following completion of treatment.
- •Men with female partners of childbearing potential should use effective contraception during this time.
- •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 184
- •F.1.3 Elderly (>=65 years) yes
- 另有 1 项未显示
排除标准
- •1) Sex and Reproductive Status
- •a) Women who are pregnant or breastfeeding;
- •b) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period
- •and for up to 6 months after the study;
- •c) Women with a positive pregnancy test on enrollment or prior to investigational product administration;
- •d2) Target Disease Exceptions
- •Nivolumab Ipilimumab Guadecitabine
- •NIBIT-ML-1 Clinical Protocol
- •a) Any malignancy from which the patient has been disease-free for less than 2 years, with the exception of
- •adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ
- •of the cervix
- •b) Primary ocular melanoma.
- •3) Medical History and Concurrent Diseases
- •a) Symptomatic brain metastases requiring immediate local intervention (radiotherapy (RT) and/or surgery);
- •b) Leptominingeal involvement by disease;
- •c) Autoimmune disease: Patients with a documented history of Inflammatory Bowel Disease, including ulcerative
- •colitis and Crohn’s disease are excluded from this study as are patients with a documented history of
- •symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma],
- •Systemic Lupus Erythematosus, autoimmune vasculitis [e.g., Wegener’s Granulomatosis] and autoimmune
- •hepatitis. Subjects with motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre Syndrome) are
- •also excluded from this study;
- •d) Any underlying medical condition, which in the opinion of the investigator, will make the administration of
- •study drug hazardous or obscure the interpretation of adverse events, such as a condition associated with frequent
- •4) Prohibited Treatments and/or Therapies
- •a) Concomitant therapy with any anti-cancer agent; immunosuppressive agents; any non-oncology vaccine therapy
- •used for prevention of infectious diseases (for up to 1 month prior to or after any dose of study drug); surgery or
- •radiotherapy (except palliative surgery and/or radiotherapy to treat a non-target symptomatic lesion or to the
- •brain after Sponsor approval); other investigational anti-cancer therapies; or chronic use of systemic
- •corticosteroids (used in the management of cancer or non-cancer-related illnesses);
- •b) Previous treatment with other investigational products, including cancer immunotherapy, within 30 days;
- •c) Prior treatment with anti-CTLA-4, except in adjuvant setting) Sexually active fertile men not using effective birth control if their partners are WOCBP
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