Pan Tumor Study for Long-term Treatment of Cancer Patients Who Have Participated in BMS sponsored Trials Investigating Nivolumab and Other Cancer Therapies
ESTADO CLÍNICO
Reclutando
FASE/S DEL ENSAYO
Fase II
PATOLOGÍA
Leucemia linfática crónica y otros SLPC, Trasplante de progenitores hematopoyéticos, Trombosis y Anticoagulantes, Linfoma
CENTRO INVESTIGADOR
H. Fundación Jiménez Díaz
INVESTIGADOR PRINCIPAL
Manuel Domine Gomez
CENTRO INVESTIGADOR
H.U. 12 de Octubre
INVESTIGADOR PRINCIPAL
Luis Paz-Ares Rodriguez
CENTRO INVESTIGADOR
H.U. Ramón y Cajal
INVESTIGADOR PRINCIPAL
Ainara Sorias
CENTRO INVESTIGADOR
H.U. La Paz
INVESTIGADOR PRINCIPAL
Javier De Castro Carpeno
FECHA DE APERTURA
Enero, 2020
FECHA DE CIERRE
,
CRITERIOS DE INCLUSIÓN
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 longlasting response or are eligible for treatment rechallenge as defined in the Parent Study.
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 longlasting response or are eligible for treatment rechallenge as defined in the Parent Study.
CRITERIOS DE EXCLUSIÓN
For Participants planning to enter the study on nivolumab treatment: Participant is not eligible for study treatment per the Parent Study eligibility criteria
Participants with any condition which, in the judgment of the Investigator, may pose a significant risk to the participant.
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.
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
DESCRIPCIÓN
The main objective of this study is to evaluate long-term safety of nivolumab alone or in combination with other cancer therapies.
PALABRAS CLAVE
antagonistas de la vitamin k, cord blood, donor lymphocyte infusion, leucemia linfocítica crónica (llc / cll), umbilical cord blood, vitamin k antagonist
