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A Multicenter, Open Label, Phase III Extension Trial to Study the Long-term Safety and Efficacy in Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab Trial - MK-3475-587 (Keynote-587)

Studio Clinico

Patologia: Neoplasie del polmone, Melanoma, Altre neoplasie

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: III

Richiesta mandatoria di tessuto: No

Linee di trattamento: Non applicabile

Criteri di inclusione: 

- Advanced unresectable or metastatic tumor(s)
- Currently enrolled in a Merck-sponsored pembrolizumab study and is receiving study treatment or in a Follow-up Phase at the time MK-3475-587 is open. The parent studies must have completed all regulatory requirements and submissions, if any, or have fully addressed their primary endpoint(s) before all their participants roll over into this MK-3475-587 extension study.

Criteri di esclusione: 

There are no exclusion criteria to participate in MK-3475-587

Trattamento sperimentale: 

Pembrolizumab
pembrolizumab+SOC/standard of Care (Per Parent Study)

Trattamento di controllo: 

SOC (Per Parent Study)

Obiettivi primari dello studio: 

Overall Survival (OS) [Time Frame: Up to approximately 10 years]
OS is defined as the time from randomization or start of study treatment for non-randomized participants (on the parent study) to death due to any cause. Participants without documented death at the time of analysis will be censored at the date of the last follow-up.

Obiettivi secondari dello studio: 

1. Duration of Response (DOR) Per Evaluation Criteria Used in the Parent Study [Time Frame: Up to approximately 10 years]
DOR is determined by disease assessment and is defined as the time from the earliest date of qualifying response on the parent study until earliest date of disease progression or death from any cause, whichever comes first based upon investigator assessment. The DOR will be presented.

2. Duration of Complete Response (DOCR) Per Evaluation Criteria Used in the Parent Study [Time Frame: Up to approximately 10 years]
DOCR is determined by disease assessment and is defined as the time from the date of complete response (CR) on the parent study until earliest date of disease progression or death from any cause, whichever comes first based upon investigator assessment. The DOCR will be presented.

3. Serious Adverse Events (SAEs) [Time Frame: Up to approximately 42 months (Up to 90 days after last dose of study treatment)]
A SAE is defined as any untoward medical occurrence that, at any dose: Results in death, Is life-threatening, Requires inpatient hospitalization or prolongation of existing hospitalization, Results in persistent or significant disability/incapacity or Is a congenital anomaly/birth defect. The number of participants who experience a SAE in this study will be presented.

4. Adverse Events of Special Interest (AEOSI) [Time Frame: Up to approximately 40 months (Up to 30 days after last dose of study treatment)]
AEOSI for this study include selected preferred terms from Medical Dictionary for Regulatory Activities (MedDRA) version 20.1 for the following higher-level terms: Pneumonitis, Colitis, Hepatitis, Nephritis, Adrenal Insufficiency, Hypophysitis, Hyperthyroidism, Hypothyroidism, Thyroiditis, Type 1 Diabetes Mellitus, Severe Skin Reactions Including Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN): or If grade 3 or higher, Uveitis, Pancreatitis, Myositis, Guillain-Barre Syndrome, Myocarditis, Encephalitis, Sarcoidosis, Infusion Reactions and Myasthenic Syndrome. The number of participants who experience an AEOSI in this study will be presented.

5. Events of Clinical Interest (ECI) [Time Frame: Up to approximately 40 months (Up to 30 days after last dose of study treatment)]
ECIs for this study include: 1) An overdose of Sponsor's product, that is not associated with clinical symptoms or abnormal laboratory results or 2) An elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) lab value that is ≥3X the upper limit of normal (ULN) and an elevated total bilirubin lab value that is ≥2X ULN and, at the same time, an alkaline phosphatase lab value that is <2X ULN, as determined by way of protocol-specified laboratory testing or unscheduled laboratory testing. The number of participants who experience an ECI in this study will be presented.

Centri partecipanti

Sud Italia e isole

Istituto Nazionale Tumori IRCCS Fondazione Pascale
Via Mariano Semmola - 80131 Napoli - NA

Riferimento: Dr. Paolo Ascierto
Telefono: 0815903236
Email: p.ascierto@istitutotumori.na.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2017-004417-42

Data di inserimento: 11.02.2019

Promotore

Merck Sharp & Dohme Corp.

CRO

/

Principal Investigator ITALIA

Istiuto nazionale dei Tumori IRCCS - Fondazione Pascale, Napoli

Riferimento: Dr. Paolo Ascierto

Telefono: 0815903236

Email: p.ascierto@istitutotumori.na.it

Localita: Napoli

 

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