EUCTR2018-004362-34-DE进行中（未招募）1 期
Pan Tumor Study for Long-term Treatment of Cancer Patients Who Have Participated in BMS sponsored Trials Investigating Nivolumab and Other Cancer Therapies - Pan tumor Rollover Study
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
- 1,231
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
- •-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 long-lasting response or are eligible for treatment rechallenge as defined in the Parent Study.
- •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 654
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 577
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.
- •-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
- •-Participants with any condition which, in the judgment of the Investigator, may pose a significant risk to the participant.
研究者
相似试验
进行中（未招募）
1 期
Study to evaluate long-term safety of nivolumab alone or in combination with other cancer therapies.pan tumorMedDRA version: 20.0Level: LLTClassification code 10007050Term: CancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2018-004362-34-PLBristol-Myers Squibb International Corporation1,231
进行中（未招募）
1 期
Study to evaluate long-term safety of nivolumab alone or in combination with other cancer therapies.pan tumorMedDRA version: 20.0Level: LLTClassification code 10007050Term: CancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2018-004362-34-ATBristol-Myers Squibb International Corporation1,231
进行中（未招募）
1 期
Study to evaluate long-term safety of nivolumab alone or in combinationwith other cancer therapies.EUCTR2018-004362-34-HUBristol-Myers Squibb International Corporation1,231
招募中
1 期
Pan tumor Roll Over StudyCTIS2023-506914-32-00Bristol Myers Squibb International Corporation585
进行中（未招募）
1 期
Study to evaluate long-term safety of nivolumab for subjects with cancer who will be provided nivolumab or have finished treatment and are now in or have completed follow up on another study of nivolumab or nivolumab combinatiopan tumorMedDRA version: 20.0Level: LLTClassification code 10007050Term: CancerSystem Organ Class: 100000004864EUCTR2018-004362-34-NLBristol-Myers Squibb International Corporation1,231