Pan Tumor Nivolumab Rollover Study

JRCT ID: jRCT2080225364

Registered date:27/08/2020

Basic Information

• Recruitment status: recruiting
• Health condition(s) or Problem(s) studied: Cancer
• Date of first enrollment: 01/10/2020
• Target sample size: 1200
• Countries of recruitment: Japan,Asia except Japan,North America,South America,Europe,Oceania
• Study type: Interventional

Intervention(s)

investigational material(s)
Generic name etc :
INN of investigational material : Nivolumab
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material :

control material(s)
Generic name etc :
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material :

Outcome(s)

Primary Outcome

Incidence of adverse events (including related AEs,
AEs leading to discontinuation, SAEs, select AEs,
immune-mediated AEs, and deaths)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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: -

Exclude 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.

Related Information

• Primary Sponsor: Bristol-Myers Squibb
• Secondary ID(s): NCT03899155,JapicCTI-205460