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A Phase 3, Randomized, Double-Blind Study of Pembrolizumab Plus Ipilimumab vs Pembrolizumab Plus Placebo in Previously Untreated, Stage IV, Metastatic Non-small Cell Lung Cancer Subjects Whose Tumors Are PD-L1 Positive (TPS ≥ 50%) KEYNOTE598

Studio Clinico

Patologia: Neoplasie del polmone

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: III

Richiesta mandatoria di tessuto: 

Linee di trattamento: Prima linea

Criteri di inclusione: 

  • Has a histologically or cytologically confirmed diagnosis of Stage IV metastatic NSCLC (American Joint Committee on Cancer version 8)
  • Has measurable disease per RECIST 1.1 as determined by investigator
  • Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Has a life expectancy of >3 months
  • Has provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
  • Female participants of childbearing potential must have a negative serum pregnancy test within 72 hours prior to receiving the first dose of study therapy
  • Female and male participants of reproductive potential must agree to use contraception starting from the first dose of study medication, throughout the study period, and for up to 120 days after the last dose of study medication
  • Male participants must refrain from donating sperm starting from the first dose of study medication, throughout the study period, and for up to 120 days after the last dose of study medication

Criteri di esclusione: 

  • Has received prior systemic chemotherapy/other targeted or biological antineoplastic therapy treatment for their Stage IV metastatic NSCLC
  • Has a tumor that harbors an epidermal growth factor receptor (EGFR)-sensitizing (activating) mutation or an anaplastic lymphoma kinase (ALK) translocation
  • Is currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study therapy
  • Has received prior therapy with an anti-Programmed Cell Death Receptor 1 (PD-1), Programmed Cell Death Receptor Ligand 1 (anti-PD-L1), or anti- Programmed Cell Death Receptor Ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137)
  • Has received prior radiotherapy within 2 weeks of start of study therapy or received lung radiation therapy of >30 Gray (Gy) within 6 months of the first dose of study therapy
  • Has recovered from all radiation-related toxicities, does not require corticosteroids, and has not had radiation pneumonitis
  • Is receiving systemic steroid therapy ≤7 days prior to the first dose of study therapy or receiving any other form of immunosuppressive medication
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or curatively resected in situ cancers
  • Has known untreated central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs)
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (i.e., doses exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study therapy
  • Has a history of (non-infectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease
  • Has had an allogeneic tissue/solid organ transplant
  • Has received a live vaccine within 30 days prior to the first dose of study therapy
  • Has an active infection requiring systemic therapy
  • Has a known history of human immunodeficiency virus (HIV) infection
  • Has a known history of hepatitis B or known active hepatitis C virus infection
  • Has a known history of active tuberculosis
  • Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the trial
  • Is a regular user of any illicit drugs or had a recent history of substance abuse
  • Is pregnant or breast feeding or expecting to conceive or father starting from the first dose of study medication, throughout the study period, and for up to 120 days after the last dose of study medication
  • Has severe hypersensitivity to pembrolizumab and/or any of its excipients and/or to ipilimumab and/or any of its excipients
  • Has a ROS1 translocation

Trattamento sperimentale: 

Pembrolizumab Plus Ipilimumab

Trattamento di controllo: 

Pembrolizumab Plus Placebo

Obiettivi primari dello studio: 

- Overall Survival (OS) [ Time Frame: Up to approximately 2 years ]

OS is the time from randomization to death due to any cause.

- Progression-free Survival (PFS) [ Time Frame: Up to approximately 2 years ]

PFS is the time from randomization to first documented disease progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR).

Centri partecipanti

Nord Italia

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

Riferimento: Dr. Vittorio Ferrari
Email: oncologia@asst-spedalicivili.it

 

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

Riferimento: Filippo De Marinis
Telefono: 0257489449
Email: filippo.demarinis@ieo.it

 

Istituto Clinico Humanitas Rozzano
Via Manzoni 56 - 20089 Rozzano - MI

Riferimento: Prof. Armando Santoro
Telefono: 0282244080
Email: armando.santoro@cancercenter.humanitas.it

 

A.O. San Gerardo
Via Pergolesi 33 - 20900 Monza - MB

Riferimento: Prof. Paolo Bidoli
Telefono: 0392339354
Email: p.bidoli@asst-monza.it

 

A.U.L.S.S. 21 Legnago
Via Gianella 1 - 37045 Legnago - VR

Riferimento: Dr. Andrea Bonetti
Telefono: 0442622624

 

Centro Italia

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

Riferimento: Dr. Fausto Roila
Telefono: 0755784211
Email: roila.fausto@libero.it

 

Sud Italia e isole

IRCCS Ospedale Casa Sollievo della Sofferenza
Viale Cappuccini 1 - 71013 San Giovanni Rotondo - FG

Riferimento: Dr. Antonio Rossi
Telefono: 0882410716
Email: arossi_it@yahoo.it

 

Azienda Ospedaliera Vincenzo Monaldi
Via Leonardo Bianchi 1 - 80131 Napoli - NA

Riferimento: Dr. Danilo Rocco

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2016-004364-20 / NCT03302234

Data di inserimento: 23.02.2018

Data di aggiornamento: 11.02.2019

Promotore

Merck Sharp & Dohme Corp.

CRO

N.A.

Principal Investigator ITALIA

Istituto Europeo di Oncologia - Milano

Riferimento: Dr. Filippo De Marinis

Telefono: 0257489449

Email: filippo.demarinis@ieo.it

Localita: Milano

 

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