Study to evaluate long-term safety of nivolumab alone or in combinationwith other cancer therapies.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1231

Inclusion Criteria

-Signed Written Informed Consent
- Participants must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study.
- Participant is eligible to receive continued study treatment per the Parent Study, including treatment beyond progression per investigator assessment in the Parent Study.
- Participant is on treatment hold in the Parent Study following long lasting response or are eligible for treatment rechallenge as defined in the Parent Study.
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 eligibility criteria.
-In the case of prior severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, symptoms must have completely resolved and based on investigator assessment, there are no sequelae that would place the participant at a higher risk of receiving investigational treatment.
- Participants currently in other interventional trials, including those for
coronavirus disease 2019 (COVID-19), may not participate in BMS
clinical trials until the protocol-specific washout period is achieved. If a
study participant has received an investigational COVID-19 vaccine or
other investigational product designed to treat or prevent COVID-19
prior to screening, enrollment must be delayed until the biologic impact
of the vaccine or investigational product is stabilized, as determined by
the investigator.
-Participants not receiving clinical benefit as assessed by the Investigator.
-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 BMS approval is required.)
-Participants who are compulsorily detained for treatment of either a psychiatric or physical (e.g., 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 participant.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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