2023-506914-32-00招募中2 期
Pan Tumor Study for Long-term Treatment of Cancer Patients Who Have Participated in BMS sponsored Trials Investigating Nivolumab and Other Cancer Therapies
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 306
- 试验地点
- 63
- 主要终点
- Incidence of adverse events (including related AEs, AEs leading to discontinuation, SAEs, select AEs, immune-mediated AEs, and deaths).
研究概览
简要总结
The main objective of this study is to evaluate long-term safety of nivolumab alone or in combination with other cancer therapies.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Signed Written Informed Consent
- •Participants must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study.
- •Participant is eligible to receive continued study treatment per the Parent Study, including treatment beyond progression per investigator assessment in the Parent Study.
- •Participant is on treatment hold in the Parent Study following longlasting response or are eligible for treatment rechallenge as defined in the Parent Study.
排除标准
- •For Participants planning to enter the study on nivolumab treatment: Participant is not eligible for study treatment per the Parent Study eligibility criteria
- •Participants with any condition which, in the judgment of the Investigator, may pose a significant risk to the participant.
- •In the case of prior severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, symptoms must have completely resolved and based on investigator assessment, there are no sequelae that would place the participant at a higher risk of receiving investigational treatment.
- •Participants currently in other interventional trials, including those for coronavirus disease 2019 (COVID-19), may not participate in BMS clinical trials until the protocol-specific washout period is achieved. If a study participant has received an investigational COVID-19 vaccine or other investigational product designed to treat or prevent COVID-19 prior to screening, enrollment must be delayed until the biologic impact of the vaccine or investigational product is stabilized, as determined by the investigator
- •Participants not receiving clinical benefit as assessed by the Investigator
- •Any clinical adverse event (AE), laboratory abnormality, or intercurrent illness which, in the opinion of the Investigator, indicates that participation in the study is not in the best interest of the participant
- •History of allergy or hypersensitivity to study drug components
- •Prisoners or participants who are involuntarily incarcerated (Note: Under certain specific circumstances and only in countries where local regulations permit, a person who has been imprisoned may be included or permitted to continue as a participant. Strict conditions apply and BMS approval is required
- •Participants who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness
- •Dementia or serious psychiatric condition that may compromise the informed consent process and increase the risks associated with study participation
结局指标
主要结局
Incidence of adverse events (including related AEs, AEs leading to discontinuation, SAEs, select AEs, immune-mediated AEs, and deaths).
Incidence of adverse events (including related AEs, AEs leading to discontinuation, SAEs, select AEs, immune-mediated AEs, and deaths).
次要结局
- OS defined as date of randomization, first dose, or as defined in the Parent Study until date of death from any cause or censored on the last known alive date in the rollover study
- Incidence of AEs.
研究者
GSM-CT
Scientific
Bristol Myers Squibb International Corporation
研究点 (63)
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