pan tumor MedDRA version: 20.0 Level: LLT Classification code 10007050 Term: Cancer System Organ Class: 100000004864
Conditions
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Signed Written Informed Consent a) Participants 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 participant care. b) Participants must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study. c) 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. 2) Type of Participant a) Participant is eligible for nivolumab treatment as per the Parent Study, and/or Investigator assessed clinical benefit, or b) Participant is in or has completed the follow-up phase of the Parent Study i) Participant has completed or discontinued treatment, or ii) Participant has progressed on treatment, and/or iii) Participant is on subsequent therapy 3) Age and Reproductive Status a) Male and female participants ages 18 and older 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main objective of this study is to examine long-term safety of nivolumab in participants on treatment and in follow up;Secondary Objective: Not applicable;Primary end point(s): Incidence of adverse events (AEs) (including related AEs, AEs leading to discontinuation, serious adverse events (SAEs), select AEs, immune-mediated AEs, and deaths);Timepoint(s) of evaluation of this end point: From Day 1 up to 100 Days after discontinuation of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czechia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russian Federation, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
Contacts
Public ContactGCT-SU
Bristol-Myers Squibb International Corporation
Outcome results
None listed