EUCTR2021-000050-26-PL进行中（未招募）1 期
TiNivo-2: A Phase 3, Randomized, Controlled, Multicenter, Open-label Study to Compare Tivozanib in Combination with Nivolumab to Tivozanib Monotherapy in Subjects with Renal Cell Carcinoma Who Have Progressed Following One or Two Lines of Therapy Where One Line has an Immune Checkpoint Inhibitor
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 326
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. = 18 years of age.
- •2. Radiographic disease progression during or following at least 6 weeks of treatment with ICI for locally advanced or metastatic RCC with a clear cell component either in first- or second-line treatment. Subjects must have progressed no longer than 6 months prior to randomization. An ICI is defined by anti-PD-L1 or anti-PD1 antibody including atezolizumab, avelumab, pembrolizumab, or nivolumab. Only subjects who have 1 prior line including 1 PD-1 or PD-L1 will be allowed.
- •a. Postoperative or adjuvant systemic therapy can be counted as a prior ICI therapy as long as recurrence is detected within 6 months of completion of treatment, in which case it will be counted as a prior therapy for metastatic disease. One or 2 prior therapies for metastatic disease are permissible but one of the treatments must have been an ICI.
- •b. Subjects must be off all systemic anti-cancer therapy or radiotherapy for at least 2 weeks prior to Cycle 1 Day 1.
- •3. Subjects must have recovered from the AEs of prior therapy to grade = 1 or baseline. Controlled AEs such as hypothyroidism are permitted.
- •4. Histologically or cytologically confirmed RCC with a clear cell component.
- •5. Measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST) criteria Version 1.1.
- •6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- •7. Life expectancy = 3 months.
- •8. If female and of childbearing potential, documentation of negative pregnancy test prior to enrollment.
- •9. Ability to give written informed consent and comply with protocol requirements.
- •10. Women of childbearing potential (WOCBP) must meet and/or agree to all of the contraception described in the Protocol, Inclusion Criteria section.
- •11. Men who are sexually active with WOCBP must meet and/or agree to all of the contraception described in the Protocol, Inclusion Criteria section.
- •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 180
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 146
排除标准
- •1. Subjects who received:
- •a. A single agent TKI in the first line setting followed by a single agent ICI in the second line setting.
- •b. More than 2 prior lines of therapy in the advanced or metastatic setting.
- •2. History of allergy or hypersensitivity to study drug or components.
- •3. History of life-threatening toxicity related to prior immune therapy (e.g. anti-CTLA-4 or anti-PD-1/PD-L1 treatment or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) except those that are unlikely to re-occur with standard countermeasures (e.g., hypothyroidism).
- •4. Active autoimmune disease as well as those that required discontinuation of prior immunooncological (IO) therapy due to immune mediated AEs. Exceptions for participants with type I diabetes mellitus, hypothyroidism, and other endocrine disorders only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur.
- •5. Uncontrolled hypertension: systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg on 2 or more antihypertensive medications, documented on 2 consecutive measurements taken at least 2 hours apart. Anti-hypertensives must not have been increased for 14 days prior to the first dose of study drug.
- •6. Condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) within 14 days of treatment initiation or other immunosuppressive medications within 30 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid doses < 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
- •7. Serious or uncontrolled medical disorder.
- •8. Treatment with any live or attenuated vaccine within 30 days of start of treatment.
- •9. Prior radiation therapy within 2 weeks prior to randomization of start of study treatment. Subjects should have recovered (i.e., Grade = 1 or at baseline) from radiation-related toxicities.
- •10. Investigational agents for the treatment of RCC. Subjects can be on a prior clinical trial if the specific agent is known (i.e., if any blind is broken).
- •11. Prior treatment with tivozanib.
- •12. More than 1 prior line of therapy with a checkpoint inhibitor in the metastatic setting.
- •13. Known central nervous system (CNS) metastases other than stable, treated brain metastases. Subjects with previously treated brain metastasis will be allowed if the brain metastasis has been stable by neuroimaging for at least 2 months following prior treatment (radiotherapy or surgery), and subjects are off all steroid treatment.
- •14. Any of the hematologic abnormalities mentioned in the protocol.
- •15. Any of the serum chemistry abnormalities mentioned in the protocol.
- •16. Significant cardiovascular disease.
- •17. Active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other gastrointestinal condition with increased risk of perforation; history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to administration of first dose of study drug.
- •18. Serious/active infection or infection requiring parenteral antibiotics.
- •19. Inadequate recovery from any prior surgical procedure or major surgical procedure within 4 weeks prior to administration of first dose of study drug.
- •20. Significant thromboembolic or vascular disorders within 6 months prior to administration of fi
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