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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: Melanoma, Neoplasie del polmone, Altre neoplasie

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: III

Linee di trattamento: Non applicabile

Criteri di inclusione: 

- - Treated on the parent pembrolizumab studies established by the Sponsor as MK-3475-587 ready
Currently receiving pembrolizumab or in a follow-up phase
Additional eligibility criteria for participants who enter Second Course Phase once they are enrolled on MK-3475-587:
- Has not received any anticancer systemic treatment since the last dose of pembrolizumab or a pembrolizumab-based combination in First Course Phase
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Demonstrates adequate organ function
- Have resolution of any toxic effect(s) of First Course Phase trial treatment with pembrolizumab or a pembrolizumab-based combination to Grade 1 or less (except alopecia) before trial treatment in Second Course Phase is started. If participant received major surgery or radiation therapy of >30 Gray (Gy), they must have recovered from the toxicity and/or complications of the intervention.
- A female participant is eligible to enroll if she is not pregnant, not breastfeeding, and ≥1 of the following conditions applies: A woman of childbearing potential (WOCBP) who agrees to use contraception during the study treatment period and for ≥120 days (corresponding to time needed to eliminate any study combination treatment(s) plus 30 days (a menstruation cycle) for study treatments with risk of genotoxicity.

Criteri di esclusione: 

There are no exclusion criteria to participate in MK-3475-587.
Participants are excluded from entering Second Course trial treatment once they are enrolled on MK-3475-587 if any of the following criteria applies:
- Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients
- Has received a live vaccine within 30 days prior to the first dose of Second Course Phase trial treatment
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the Cycle 1 Day 1 of Second Course Phase
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include early stage cancers (carcinoma in situ or Stage 1) treated with curative intent, melanoma (non-ulcerated, thin primary), basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, or in situ breast cancer that has undergone potentially curative therapy.
- Has known active central nervous system metastases and/or carcinomatous meningitis
- Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
- Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. Note: Participants that experienced pneumonitis during First Course that did not meet the criteria for permanent discontinuation are eligible.
- Non-small cell lung cancer (NSCLC) participants only: Has interstitial lung disease
- Has an active infection requiring systemic therapy
- Has a known history of human immunodeficiency virus (HIV) infection.
- Has a known history of or is positive for hepatitis B or hepatitis C. For parent studies where inclusion of participants with hepatitis was permitted, MK-3475-587 will follow the parent study eligibility criteria for hepatitis.
- Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the Second Course Phase eligibility Visit through 120 days after the last dose of study treatment.
- Has severe cardiovascular disease, i.e., arrhythmias, requiring chronic treatment, congestive heart failure (New York Heart Association Class III or IV) or symptomatic ischemic heart disease.
- Has hepatic decompensation (Child-Pugh score >6 [class B and C])
- Has uncontrolled thyroid dysfunction
- Has uncontrolled diabetes mellitus
- Has had an allogeneic tissue/solid organ transplant
- Has a known history of active tuberculosis (TB; Bacillus tuberculosis).

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.

Centri partecipanti

Nord Italia

Cliniche Humanitas Gavazzeni
Via Gavazzeni 21 - 24125 Bergamo - BG

 

Ospedale Papa Giovanni XXIII Bergamo
Piazza OMS 1 - 24127 Bergamo - BG
UOC Oncologia

Riferimento: Dr. Carlo Tondini
Email: carlo.tondini@asst-pg23.it

 

ASST Spedali Civili di Brescia
Piazzale Spedali Civili 1 - 25123 Brescia - BS

Riferimento: Dr. Vittorio Ferrari
Telefono: 0303995260
Email: oncologia.trial.brescia@asst-spedalicivili.it

 

IRCCS A.O.U. San Martino - IST
Largo Rosanna Benzi 10 - 16132 Genova - GE

Riferimento: Dr. Giuseppe Fornarini
Telefono: 0105553301
Email: giuseppe.fornarini@hsanmartino.it

 

Istituto Europeo di Oncologia
Via Ripamonti 435 - 20141 Milano - MI

Riferimento: Dr.ssa Paola Queirolo
Telefono: 0257489459
Email: Paola.queirolo@ieo.it

 

Istituto Clinico Humanitas Rozzano
Via Manzoni 56 - 20089 Rozzano - MI
UO di Oncologia Medica ed Ematologia

Riferimento: Prof. Armando Santoro
Email: armando.santoro@cancercenter.humanitas.it

 

Azienda Ospedaliero-Universitaria di Parma
Via Gramsci 14 - 43126 Parma - PR

Riferimento: Prof. Marcello Tiseo
Telefono: 0521702682
Email: marcello.tiseo@unipr.it

 

Centro di Riferimento Oncologico
Via Franco Gallini 2 - 33081 Aviano - PN

Riferimento: Dr.ssa Sandra Santarossa
Telefono: 0434659043
Email: ssantarossa@cro.it

 

IRCCS Candiolo (TO)
St.Provinciale Km 3,95 SP142 - 10060 Candiolo - TO

 

Centro Italia

Azienda Ospedaliera di Perugia
Via Dottori 1 - 06132 Perugia - PG
Ospedale Santa Maria della Misericordia

Riferimento: Dr.ssa Maria Francesca Currà
Telefono: 0755784188
Email: mfrancesca.curra@ospedale.perugia.it

 

Azienda Ospedaliera San Camillo Forlanini
Via Portuense 332 - 00149 Roma - RM

 

Fondazione Policlinico A. Gemelli
Largo Agostino Gemelli 8 - 00168 Roma - RM
UOC Ginecologia Oncologica

Riferimento: Prof. Giovanni Scambia
Email: giovanni.scambia@policlinicogemelli.it

 

Fondazione Policlinico A. Gemelli
Largo Agostino Gemelli 8 - 00168 Roma - RM
UOC Oncologia Medica

Riferimento: Prof. Giampaolo Tortora
Telefono: 0630155202
Email: oncomedsperimentali@policlinicogemelli.it

 

Azienda Ospedaliera Universitaria Senese
Viale Bracci 16 - 53100 Siena - SI
Ospedale Le Scotte - UOC Immunoterapia oncologica

 

AO S. Maria Terni
Via Tristano di Joannuccio 1 - 05100 Terni - TR

Riferimento: Dr. Sergio Bracarda
Telefono: 0744205631
Email: s.bracarda@aospterni.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2017-004417-42

Data di inserimento: 11.02.2019

Data di aggiornamento: 15.11.2023

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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