Overview

Pan Tumor Nivolumab Rollover Study

Status:
Recruiting
Trial end date:
2025-08-25
Target enrollment:
0
Participant gender:
All
Summary
Main Objective of this study is to examine long-term safety of nivolumab in participants on treatment and in follow up.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bristol-Myers Squibb
Treatments:
Nivolumab
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: -

- 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.