Study to evaluate long-term safety of nivolumab for subjects with cancer who will be provided nivolumab or have finished treatment and are now in or have completed follow up on another study of nivolumab or nivolumab combinatio

Phase 1

• Conditions: pan tumor; MedDRA version: 20.0Level: LLTClassification code 10007050Term: CancerSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-004362-34-CZ
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-07-30
• Last Update Posted: 2 May 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1231

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 654
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 577

Exclusion Criteria

For Participants planning to enter the study on nivolumab treatment:
-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
-History of allergy or hypersensitivity to study drug components
-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.)
-Participants who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness
-Dementia or serious psychiatric condition that may compromise the informed consent process and increase the risks associated with study participation
-Participants with any condition which, in the judgment of the Investigator, may pose a significant risk to the subject
Participants in survival follow-up have no exclusion criteria.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified