Pan Tumor Nivolumab Rollover Study

Study Overview
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Brief Summary
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Main Objective of this study is to examine long-term safety of nivolumab in participants on treatment and in follow up.

Official Title
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Pan-Tumor Study for Long Term Follow-up of Cancer Survivors Who Have Participated in Trials Investigating Nivolumab

Conditions
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Cancer

Intervention / Treatment
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* Drug: Nivolumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nivolumab Dose 1<br>Specified Dose on Specified Days | Drug: Nivolumab<br>* Solution for IV Injection<br>* Other names: BMS-936558-01;|
| Experimental: Nivolumab Dose 2<br>Specified Dose on Specified Days | Drug: Nivolumab<br>* Solution for IV Injection<br>* Other names: BMS-936558-01;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events (AEs) |  | From Day 1 up to 100 Days after discontinuation of treatment | 
| Incidence of drug related AEs |  | From Day 1 up to 100 Days after discontinuation of treatment | 
| Incidence of AEs leading to Discontinuation |  | From Day 1 up to 100 Days after discontinuation of treatment | 
| Incidence of Serious Adverse Events (SAEs) |  | From signature of Informed Consent up to 100 Days after discontinuation of treatment | 
| Incidence of Select AEs |  | From Day 1 up to 100 Days after discontinuation of treatment | 
| Incidence of Immune-Mediated AEs |  | From Day 1 up to 100 Days after discontinuation of treatment | 
| Incidence of Death |  | From signature of Informed Consent up to 100 Days after discontinuation of treatment |