None listed
Conditions
Interventions
Eligible for nivolumab treatment as per the Parent Study and/or Investigator assessed clinical benefit Type of group
Treatment until progression, unacceptable toxicity or withdrawal of consent or end of treatment as per Parent study
Follow-up Survival
Group name:Participant is in or has completed the follow-up phase of the Parent Study (has completed or discontinued treatment, or has progressed on treatment, and/or is on subsequent therapy) Type of group
Follow-up Survival (nivolumab is not universally approved for all indications under study)
Sponsors
BRISTOL MYERS SQUIBB COMPANY,
Eligibility
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 followup 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
Exclusion criteria
Exclusion criteria: 1. Medical Conditions a) Participant is not eligible for nivolumab treatment as per the Parent Study 2. Prior/Concomitant Therapy a) Not applicable 3. Physical and Laboratory Test Findings a) Participants not receiving clinical benefit as assessed by the Investigator (participant is still eligible for study if entering survival follow-up only) b) 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 4. Allergies and Adverse Drug Reaction a) History of allergy or hypersensitivity to study drug components 5. Other Exclusion Criteria a) 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.) b) Participants who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness c) Dementia or serious psychiatric condition that may compromise the informed consent process and increase the risks associated with study participation d) Participants with any condition which, in the judgment of the Investigator, may pose a significant risk to the subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:NA Measure:Incidence of adverse events (including related AEs, AEs leading to discontinuation, serious AEs,select AEs,immunemediated AEs, and deaths) Timepoints:From Day 1 up to 100 Days after discontinuation of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:NA Measure:NA Timepoints:NA | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Korea South, Mexico, Nederland, Norway, Poland, Romania, Russian Federation, Spain, Sweden, Switzerland, Taiwan, United Kindgdom, United States
Contacts
Public ContactJackelyn Borja
BRISTOL MYERS SQUIBB PERU S.A.
Outcome results
None listed