Safety Study of Nivolumab for Selected Advanced Malignancies in India
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 10
- 主要终点
- Incidence and severity of treatment related AEs
研究概览
简要总结
On 09 June 2016, nivolumab received approval from the Health Authorities of India for the treatment of (1) locally advanced or metastatic NSCLC after prior chemotherapy and. (2) advanced RCC after prior therapy in adults. As a condition of granting approval, the Health Authorities of India have required that a Phase 4 clinical trial in participants in India must be conducted by BMS so that adverse reactions related to the drug are reported to the Health Authorities in India and subsequently, any regulatory action resulting from their review should be complied with by the Sponsor.
The present study is a Phase 4 safety study of nivolumab to be conducted in India to comply with this condition specified in the approval letter received by BMS.
This study will provide information on the safety profile of nivolumab for the treatment of NSCLC or mRCC in a limited number of participants in India in accordance with the requirements of the Health Authorities of India.
This study will describe the adverse reactions that occur during 6 months of treatment with nivolumab in participants with advanced NSCLC or RCC in India. No test of the statistical hypothesis is planned in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
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.
- •{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.
结局指标
主要结局
Incidence and severity of treatment related AEs
时间窗: During study period, at the time of discontinuation and 26 week for continuously treated patients by nivolumab after study period
次要结局
- Incidence and severity of treatment-related select AEs, as specified in Section 10.3.2 of protocol in all treated participants(During study period, at the time of discontinuation and 26 week for continuously treated patients by nivolumab after study period)
- Incidence of AEs that lead to discontinuation from treatment with nivolumab(At the time of discontinuation)
- Incidence of all treatment-related SAEs(During study period, at the time of discontinuation and 26 week for continuously treated patients by nivolumab after study period)