E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
various types of cancer |
Vários tipos de cancro |
|
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 | 100000004864 |
|
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 examine long-term safety of nivolumab in participants on treatment and in follow up |
Segurança a longo prazo do nivolumab em participantes sob tratamento e em seguimento |
|
E.2.2 | Secondary objectives of the trial |
Not applicable |
Não aplicável |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
- Consentimento Informado Assinado
- Participantes que tinham completado tratamento com nivolumab, progrediram num tratamento anterior con nivolumab ou interromperam o tratamento com nivolumab devido à toxicidade, no estudo em curso (estudo principal) não são elegíveis para receber nivolumab neste estudo. Esses participantes podem estar inscritos apenas para acompanhamento de segurança e sobrevivência.
- O participante é elegível para o tratamento com nivolumabe com base no benefício clínico avaliado para o estudo principal e / ou investigador |
|
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
-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. |
Para que os participantes participem do estudo sobre o tratamento com nivolumabe:
- O participante não é elegível para o tratamento com nivolumab por a avaliação no estudo principal.
- Participantes que não recebem benefício clínico segundo o investigador (o participante ainda é elegível para o estudo se entrar apenas no acompanhamento da sobrevida).
- Qualquer evento adverso clínico (EA), anormalidade laboratorial ou doença intercorrente que, na opinião do investigador, indique que a participação no estudo não é do melhor interesse do participante |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Incidence of adverse events (AEs) (including related AEs, AEs leading to discontinuation, serious adverse events (SAEs), select AEs,immune-mediated AEs, and deaths) |
Incidência de acontecimentos adversos (incluindo AA relacionados, AA conducentes a descontinuação, AA graves, AA selecionados, AA imunomediados e mortes) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
From Day 1 up to 100 Days after discontinuation of treatment |
Do dia 1 ate 100 dias após a descontuação do tratamento |
|
E.5.2 | Secondary end point(s) |
Not applicable |
Não aplicavel |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Not applicable |
Não aplicavel |
|
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 |
|
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 | 2 |
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 |
Australia |
Chile |
Mexico |
Argentina |
Austria |
Belgium |
Brazil |
Canada |
China |
Czechia |
Denmark |
Finland |
Germany |
Greece |
Hungary |
Ireland |
Israel |
Italy |
Japan |
Korea, Republic of |
Netherlands |
New Zealand |
Norway |
Poland |
Portugal |
Romania |
Russian Federation |
Spain |
Sweden |
Switzerland |
Taiwan |
United Kingdom |
United States |
France |
|
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
|
When all participants are no longer being followed for survival |
Quando todos os participantes não estão mais a ser seguidos para availar a sobrevivência |
|
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 |