Cancer
Conditions
Interventions
investigational material(s)
Generic name etc :
INN of investigational material : Nivolumab
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational materia
Sponsors
Bristol-Myers Squibb
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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, or 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 Exclusion Criteria: -
Exclusion criteria
Exclusion criteria: 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 Participants in survival follow-up have no exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events (including related AEs, AEs leading to discontinuation, SAEs, select AEs, immune-mediated AEs, and deaths) | — |
Countries
Asia except Japan, Europe, Japan, North America, Oceania, South America
Contacts
Public ContactSoomro Raheela
Bristol-Myers Squibb
Outcome results
None listed