EUCTR2016-000742-61-IT进行中（未招募）1 期
CLINICAL STUDY OFNIVOLUMAB COMBINED WITH IPILIMUMAB IN SUBJECTS WITH UNRESECTABLE OR METASTATIC MELANOMA. (NIVOLUMABIPILIMUMABAT 1MG/KG – NIVOIPI01) - NA
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
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 .Subjects capable of giving informed consent must have signed and dated an IRB/IEC approved written informed consent form
- •in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol related
- •procedures that are not part of normal subject care.
- •2. Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other
- •requirements of the study.
- •3. Histologically confirmed unresectable Stage III or Stage IV melanoma, as per AJCC staging system.
- •4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Refer to Appendix 4)
- •5. Treatment naïve subjects (ie, no prior systemic anticancer therapy for unresectable or metastatic melanoma). Note that prior
- •adjuvant or neoadjuvant melanoma therapy is permitted if it was completed at least 6 weeks prior to randomization, and all
- •related adverse events have either returned to baseline or stabilized.
- •6. Measurable disease by CT or MRI per RECIST 1.1 criteria [89]
- •7. Tumor tissue from an unresectable or metastatic site of disease must be provided for disease diagnsis.
- •8. Subjects must have known BRAF V600 mutation status or consent to BRAF V600 mutation testing per local institutional
- •standards during the Screening Period.
- •9. Prior radiotherapy must have been completed at least 2 weeks prior to study drug
- •administration.
- •10. Screening laboratory values must meet the following criteria and should be obtained within 14 days prior to study entry:
- •i) WBC = 2000/µL
- •ii) Neutrophils = 1500/µL
- •iii) Platelets =100 x103/µL
- •iv) Hemoglobin = 9.0 g/dL
- •v) Serum creatinine = 1.5 x ULN or creatinine clearance (CrCl) = 40 mL/min (using the
- •Cockcroft-Gault formula):
- •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
- •vi) AST/ALT = 3 x ULN
- •vii) Total Bilirubin = 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL).
- •viii) normal ACTH level, and thyroid function tests, negative pregnancy test within 24 hours prior to the start of investigational
- •11. Men and women, >18 years of age
- •12. Women of childbearing potential (WOCBP as defined below) and Men who are sexually active with WOCBP must use any
- •contraceptive method with a failure rate of less than 1% per year as indicated in Appendix 5 for at least 6 and 7,5 months,
- •respectively, after the last dose of investigational drug (see also 2014_09_HMA_CTFG_Contraception.pdf).
- •13. Subject must consent to undergo a biopsy of their metastasis for confirmation of the diagnosis and/or BRAF V600 mutational
- •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 10
排除标准
- •1.Active brain metastases or leptomeningeal metastases. Subjects with brain metastases are eligible if these have been treated
- •and there is no magnetic resonance imaging (MRI) evidence of progression for at least 8 weeks after treatment is complete and
- •within 28 days prior to first dose of study drug administration. There must also be no requirement for immunosuppressive doses of
- •systemic corticosteroids (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration.
- •2.Ocular melanoma
- •3.Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study
- •participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the
- •interpretation of study results.
- •4.Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as
- •basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
- •5.Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual
- •hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or
- •conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- •6.Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or
- •other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids, and adrenal
- •replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
- •7.Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically
- •targeting T-cell costimulation or immune checkpoint pathways, are permitted only under exceptional circumstances and always
- •after PI approval.
- •8.Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute
- •or chronic infection, as determined in subjects where the condition is unknown at time of study entry.
- •9.Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome
- •10.History of allergy to study drug components.
- •11.History of severe hypersensitivity reaction to any monoclonal antibody.
- •12.WOCBP who are pregnant or breastfeeding
- •13.Women with a positive pregnancy test at enrollment or prior to administration of study medication.
- •14.Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness
- •Women of Childbearing Potential
- •Women of childbearing potential (WOCBP) is defined as any female who has experienced menarche and who has not undergone
- •surgical sterilization (hysterectomy or bilateral oophorectomy) or is not postmenopausal. Menopause is defined clinically as 12
- •months of amenorrhea in a woman over age 45 in the absence of other biological or physiological causes.In additional, women
- •under the age of 62 must have a documented serum follicle stimulating hormone, (FSH) level > 40mIU/mL.
- •Prohibited and/or Restricted Treatments
- •The following medications are prohibited during the study:
- •Immunosuppressive agents (except to treat a drug-related adverse event)
- •Systemic corticost
研究者
相似试验
进行中（未招募）
1 期
A Study of Nivolumab and Ipilimumab Combined with Chemotherapy Compared to Chemotherapy by Itself as the First Treatment Given for Stage IV Non-Small Cell Lung Cancer (NSCLC) (CheckMate 9LA)Stage IV Non-Small Cell Lung Cancer (NSCLC)MedDRA version: 20.0Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2017-001195-35-ESBristol-Myers Squibb International Corporation504
进行中（未招募）
1 期
A Study of Nivolumab and Ipilimumab Combined with Chemotherapy Compared to Chemotherapy by Itself as the First Treatment Given for Stage IV Non-Small Cell Lung Cancer (NSCLC) (CheckMate 9LA)Stage IV Non-Small Cell Lung Cancer (NSCLC)MedDRA version: 20.0Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2017-001195-35-FRBristol-Myers Squibb International Corporation504
已完成
3 期
CheckMate743JPRN-jRCT2080223370Bristol-Myers Squibb K.K.600
已完成
2 期
O LIMIT StudyJPRN-jRCT2080225304Hisato Kawakami (Coordinating Investigator)28
已完成
4 期
A Phase 4 Study of Combination Nivolumab and Ipilimumab in Patients with Advanced Renal Cell Carcinoma in IndiaCTRI/2020/10/028626BRISTOL MYERS SQUIBB INDIA PRIVATE LIMITED101