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

Phase 1

Conditions: pan tumor
MedDRA version: 20.0Level: LLTClassification code 10007050Term: CancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2018-004362-34-DE

Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary: Not available

Detailed Description: Not available

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 study treatment 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
Main Objective: The main objective of this study is to evaluate long-term safety of nivolumab alone or in combination with other cancer therapies.;Secondary Objective: - To follow participants who have completed therapy and are in or have completed follow-up on a Parent Study investigating nivolumab or nivolumab combination therapy for long-term efficacy (including overall survival [OS]).<br><br>- Safety of cancer therapies used as comparator in Parent Studies.<br><br>;Primary end point(s): Incidence of adverse events (including related AEs, AEs leading to discontinuation, SAEs, select AEs, immune-mediated AEs, and deaths).;Timepoint(s) of evaluation of this end point: From Day 1 up to 100 Days (135 days for relatlimab-treated participants) after discontinuation of treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - OS defined as date of randomization, first dose, or as defined in the Parent Study until date of death from any cause or censored on the last known alive date in the rollover study.<br><br>- Incidence of AEs.;Timepoint(s) of evaluation of this end point: Not applicable

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