EUCTR2016-002170-13-DE进行中（未招募）1 期
A randomized phase II study with NIVOlumab or continuation of therapy as an early SWITCH approach in patients with advanced or metastatic renal cell carcinoma (RCC) and disease control after 3 months of treatment with a tyrosine kinase inhibitor - NIVOSWITCH
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 244
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. Written informed consent and any locally-required
- •authorization (EU Data Privacy Directive in the EU) obtained
- •from the subject prior to performing any protocol-related
- •procedures, including screening evaluations.
- •2. Subject is willing and able to comply with the protocol for the
- •duration of the study including undergoing treatment and
- •scheduled visits and examinations including follow up.
- •3. Age = 18 years at time of study entry
- •4. ECOG performance status 0-2.
- •5. Metastatic or locally advanced RCC with clear cell
- •component, not amenable to surgery with curative intention.
- •6. First-line treatment with a TKI for 10-12 weeks (limited to
- •sunitinib or pazopanib).
- •7. Patients with measurable disease (at least one unidimensionally
- •measurable target lesion by CT-scan or MRI)
- •according to modified Response Evaluation Criteria in Solid
- •Tumors (RECIST 1.1). If prior palliative radiotherapy to
- •metastatic lesions: = 1 measurable lesion that has not been
- •irradiated. Patients with bone lesions as the only measurable
- •lesion are eligible, provided that lesions consist of soft tissue,
- •which is assessed via CT or MRI.
- •8. Documented partial response or stable disease to first-line
- •TKI exposure at 10-12 weeks.
- •9. Prior therapies other than indicated in the exclusion critiria
- •and surgeries are allowed if completed 4 weeks (for minor surgery and palliative radiotherapy for bone pain: 2 weeks)
- •prior to start of treatment and patient recovered from toxic
- •10. Adequate blood count, liver-enzymes, and renal function
- •(obtained no later than 14 days prior to start of study
- •treatment):
- •? WBC = 2000/µL
- •? Neutrophils = 1500/µL
- •? Platelets = 100 x103/µL
- •? Hemoglobin > 9.0 g/dL
- •? Serum creatinine = 1.5 x ULN or 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
- •? AST/ALT = 3 x ULN
- •? Total Bilirubin = 1.5 x ULN (except subjects
- •with Gilbert Syndrome, who can have total
- •bilirubin < 3.0 mg/dL)
- •11. Women of childbearing potential (WOCBP) must use
- •appropriate method(s) of contraception. WOCBP should use
- •an adequate method to avoid pregnancy for 23 weeks (30
- •days plus the time required for nivolumab to undergo five
- •half-lives) after the last dose of nivolumab.
- •12. Women of childbearing potential must have a negative serum
- 另有 15 项未显示
排除标准
- •1. Prior systemic therapy other than 10-12 weeks SOC TKI
- •treatment for advanced or metastatic RCC.
- •2. Standard of care 1st-line TKI treatment for advanced or
- •metastatic RCC for longer than 12 weeks.
- •3. Complete remission (CR) or progression during SOC TKI 1st-
- •line treatment.
- •4. Termination of first-line treatment with TKI due to intolerance
- •5. Previous malignancy (other than renal cell cance
- •cancer of the skin, pre-invasive cancer of the cervix, T1a
- •prostate carcinoma or superficial bladder tumor [Ta, Tis and
- •T1] are exempted.
- •6. Brain metastases mandating active treatment. Subjects with
- •brain metastases are eligible if metastases have been treated
- •and there is no magnetic resonance imaging (MRI) evidence
- •of progression for 4 weeks after treatment is completed and
- •within 28 days prior to the first dose of nivolumab
- •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.
- •7. Prior therapy with anti-tumor vaccines or other immunostimulatory
- •antitumor agents.
- •8. Administration of a live, attenuated vaccine within 4 weeks of
- •start of therapy
- •9. Any previous 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 co-stimulation or immune
- •checkpoint pathways
- •10. Subjects must have recovered from the effects of major
- •surgery or significant traumatic injury at least 14 days before
- •the first dose of study treatment.
- •11. Patients should be excluded if they have an active, known or
- •suspected autoimmune disease. NOTE: Subjects are
- •permitted to enroll if they have 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
- •12. Patients should be excluded if they have a condition requiring
- •systemic treatment with either corticosteroids (> 10 mg daily
- •prednisone equivalents) or other immunosuppressive
- •medications within 14 days of study drug administration.
- •NOTE: Inhaled or topical steroids and adrenal replacement
- •doses > 10 mg daily prednisone equivalents are permitted in
- •the absence of active autoimmune disease.
- •13. Known chronic infection (i.e. hepatitis B or C, HIV)
- •14. Patients should be excluded if they have been positively
- •tested for hepatitis B virus surface antigen (HBV sAg) or
- •hepatitis C virus ribonucleic acid (HCV antibody) indicating
- •acute or chronic infection.
- 另有 14 项未显示
研究者
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