Pan Tumor Study for Long Term Follow-up of Cancer Survivors Who Have Participated in Trials Investigating Nivolumab
- Conditions
- CancerPan Tumor10027655
- Registration Number
- NL-OMON50106
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 10
* Signed Written Informed Consent
* Participants who have completed treatment with nivolumab, progressed on prior
nivolumab treatment or discontinued nivolumab due to toxicity, in the Parent
Study are not eligible to receive nivolumab in this study. These participants
may be enrolled for safety and survival follow-up only.
* Participant is eligible for nivolumab treatment as per the Parent Study
and/or Investigator assessed clinical benefit
For Participants planning to enter the study on nivolumab treatment:
* Participant is not eligible for nivolumab treatment as per the Parent Study
* Participants not receiving clinical benefit as assessed by the Investigator
(participant is still eligible for study if entering survival follow-up only)
* 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 Bristol-Myers Squibb
approval is required.)
* Participants who are compulsorily detained for treatment of either a
psychiatric or physical (eg, 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 subject
* Participants in survival follow-up have no exclusion criteria.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Incidence of adverse events (including related AEs, AEs leading to<br /><br>discontinuation, serious AEs, select AEs, immune-mediated AEs, and deaths)</p><br>
- Secondary Outcome Measures
Name Time Method <p>Exploratory:<br /><br>OS defined as date of randomization, first dose, or as defined in the parent<br /><br>study until date of death from any cause or censored on the last known alive<br /><br>date in the rollover study.</p><br>