CTRI/2018/02/012088招募中4 期
Safety Study of Nivolumab for Selected Advanced Malignancies in India - Nivolumab study
BRISTOLMYERS SQUIBB INDIA PRIVATE LIMITED0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Signed Written Informed Consent
- •Subjects 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.
- •b) Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests
- •and other requirements of the study.
- •Type of Participant and Target Disease Characteristics
- •Locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy OR advanced renal cell carcinoma (RCC) after prior therapy.
- •b) Eastern Cooperative Oncology Arm (ECOG) (Appendix 1) performance status of <= 1
- •c) Prior radiotherapy or radiosurgery must have been completed at least 2 weeks prior to randomization.
- •Age and Reproductive Status
- •a) Males and Females, ages >= 18 or age of majority
- •b) Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study treatment.
- •c) Women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of treatment with nivolumab and 5 months after the last dose of study treatment. {i.e., 30 days (duration of ovulatory cycle) plus the time required for the investigational drug to undergo approximately 5 half-lives}.
- •d) Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of study treatment with nivolumab and 7 months after the last dose of study treatment {i.e., 90 days (duration of sperm turnover) plus the time required for the investigational drug to undergo approximately five halflives.}
- •e) Azoospermic males are exempt from contraceptive requirements. WOCBP who are continuously not heterosexually active are also exempt from contraceptive requirements, and still must undergo pregnancy testing as described in this section.
- •Investigators shall counsel WOCBP, and male participants who are sexually active with WOCBP, on the importance of pregnancy prevention and the implications of an unexpected pregnancy. Investigators shall advise on the use of highly effective methods of contraception, (Appendix 4 which have a failure rate of < 1% when used consistently and correctly.
排除标准
- •Medical Conditions
- •a) Women who are pregnant or breastfeeding or with a positive pregnancy test at enrollment or prior to administration of study medication
- •b) Other medical conditions not to be participated in this study.
- •Prior or Concomitant Therapy
- •a) Ongoing or planned administration of anti-cancer therapies other than those specified in this study
- •b) Use of corticosteroids or other immunosuppressive medications with exceptions detailed in the protocol consistent with nivolumab program.
- •c) Treatment with any investigational agent within 14 days of first administration of study treatment.
- •Physical and Laboratory Test Findings
- •Allergies and Adverse Drug Reaction
- •Other Exclusion Criteria
- •a) Prisoners or participants who are involuntarily incarcerated. (Note: under certain specific circumstances a person who has been imprisoned may be included or permitted to continue as a participant. Strict conditions apply and Bristol-Myers Squibb approval is required.
- •b) Participants who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness.
研究者
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