E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10007050 |
E.1.2 | Term | Cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Main objective of this study is to evaluate long-term safety of nivolumab alone or in combination with other cancer therapies. |
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E.2.2 | Secondary objectives of the trial |
- 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])
- Safety of cancer therapies used as comparator in Parent Studies. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Incidence of adverse events (including related AEs, AEs leading to discontinuation, SAEs, select AEs, immune-mediated AEs, and deaths |
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E.5.1.1 | 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 |
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E.5.2 | 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 - Incidence of AEs. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 143 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Argentina |
Chile |
New Zealand |
Switzerland |
Taiwan |
Australia |
Brazil |
Canada |
China |
Israel |
Japan |
Korea, Republic of |
Mexico |
Russian Federation |
United Kingdom |
United States |
Austria |
Belgium |
Czechia |
Denmark |
Finland |
France |
Germany |
Greece |
Hungary |
Ireland |
Italy |
Netherlands |
Norway |
Poland |
Portugal |
Romania |
Spain |
Sweden |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End of study is defined as the last participant's last visit (LPLV). LPLV is when the last participant on study completes 100 (or 135 if treated with relatlimab) days follow up visit.Participants are considered to have completed the study if they have completed all periods of the study, including the last visit or the last procedure shown in the Schedule of Activities. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 5 |