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MK 6482-022 - A Multicenter, Double-blind, Randomized Phase 3 Study to Compare the Efficacy and Safety of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab, in the Adjuvant Treatment of Clear Cell Renal Cell Carcinoma (ccRCC) Post Nephrectomy

Studio Clinico

Patologia: Tumori del rene

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: III

Linee di trattamento: Adiuvante/neoadiuvante

Criteri di inclusione: 

  • Has a histologically or cytologically confirmed diagnosis of RCC with clear cell component per American Joint Committee on Cancer (AJCC) (8th Edition), with or without sarcomatoid features
  • Has intermediate-high risk, high risk, or M1 no evidence of disease (NED) RCC as defined by the following pathological tumor-node metastasis and tumor grading:
    1. Intermediate-high risk RCC: pT2, Grade 4 or sarcomatoid, N0, M0; pT3, any grade, N0, M0
    2. High risk RCC: pT4, any Grade N0, M0; pT any stage, any Grade, N+, M0
    3. M1 NED RCC participants who present not only with the primary kidney tumor but also solid, isolated, soft tissue metastases that can be completely resected at one of the following: the time of nephrectomy (synchronous) or, ≤2 years from nephrectomy (metachronous)
  • Has undergone complete resection of the primary tumor (partial or radical nephrectomy) and complete resection of solid, isolated, soft tissue metastatic lesion(s) in M1 NED participants
  • Must have undergone a nephrectomy and/or metastasectomy ≤12 weeks prior to randomization
  • Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 10 days before randomization.
  • Male participants must agree to continue contraception at least 7 days after the last dose of belzutifan/placebo
  • Female participants of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of pembrolizumab or at least 30 days after last dose of belzutifan/placebo, whichever occurs last
  • Has adequate organ function

Criteri di esclusione: 

  • Has had a major surgery, other than nephrectomy plus resection of preexisting metastases for M1 NED participants, within 4 weeks prior to randomization
  • Has a pulse oximeter reading <92% at rest, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen
  • Has clinically significant cardiovascular disease within 6 months from first dose of study intervention
  • Has other clinically significant disorders such as: serious active nonhealing wound/ulcer/bone fracture; requirement for hemodialysis or peritoneal dialysis
  • Has preexisting brain or bone metastatic lesions
  • Has received prior systemic therapy for RCC
  • Has received prior radiotherapy for RCC
  • Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention; administration of killed vaccines are allowed
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
  • Has a known additional malignancy (other than RCC treated with nephrectomy and/or metastasectomy) that is progressing or has required active treatment within the past 3 years
  • 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); replacement therapy is allowed
  • Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
  • Has an active infection, requiring systemic therapy
  • Has a known history of human immunodeficiency virus (HIV) infection, a known history of Hepatitis B or known active Hepatitis C virus infection
  • Has had an allogenic tissue/solid organ transplant

Trattamento sperimentale: 

Drug: Belzutifan
Biological: Pembrolizumab

Trattamento di controllo: 

Biological: Pembrolizumab
Drug: Placebo

Centri partecipanti

Nord Italia

Ospedale S.Orsola Malpighi, Università di Bologna
Via Pietro Albertoni 15 - 40138 Bologna - BO
Oncologia Medica

 

IRCCS - IRST Meldola Dino Amadori
Via P. Maroncelli 40 - 47014 Meldola - FC

Riferimento: Dr. Ugo De Giorgi
Telefono: 0543739100
Email: ugo.degiorgi@irst.emr.it

 

IRCCS Istituto Nazionale dei Tumori
Via Venezian 1 - 20133 Milano - MI
S.S. Oncologia Medica Genitourinaria

Riferimento: Dr.ssa Elena Verzoni
Telefono: 223904449
Email: elena.verzoni@istitutotumori.mi.it

 

Ospedale San Raffaele di Milano
Via Olgettina 60 - 20132 Milano - MI
Oncologia medica GU

Riferimento: Prof. Andrea Necchi
Email: necchi.andrea@unisr.it

 

A.O.U San Luigi Gonzaga
Regione Gonzole 10 - 10043 Orbassano - TO
UOC Oncologia Medica

Riferimento: Prof.ssa Consuelo Buttigliero
Email: consuelo.buttigliero@unito.it

 

Centro Italia

Istituto Toscano Tumori Ospedale San Donato
Via Pietro Nenni 20 - 52100 Arezzo - AR
UOC Oncologia Medica

Riferimento: Dr.ssa Alketa Hamzaj
Telefono: 0575255452
Email: alketa.hamzaj@uslsudest.toscana.it

 

AOU Careggi
Largo Brambilla 3 - 50134 Firenze - FI
Oncologia Medica

Riferimento: Prof. Lorenzo Antonuzzo
Telefono: 0557947298
Email: antonuzzol@aou-careggi.toscana.it

 

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

Riferimento: Dr. Roberto Iacovelli
Email: roberto.iacovelli@policlinicogemelli.it

 

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

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

 

Sud Italia e isole

A.O. Universitaria Consorziale Policlinico di Bari
Piazza G. Cesare 11 - 70100 Bari - BA
Oncologia Medica Universitaria

Riferimento: Prof. Camillo Porta
Telefono: 0805594167
Email: ambulatorio.profporta@gmail.com

Informazioni Generali

Protocollo

Numero di iscrizione a registro: NCT05239728

Data di inserimento: 11.05.2022

Data di aggiornamento: 23.11.2023

Promotore

Merck Sharp & Dohme LLC

CRO

/

Principal Investigator ITALIA

A.O. Universitaria Consorziale Policlinico di Bari

Riferimento: Prof. Camillo Porta

Telefono: 0805594167

Email: ambulatorio.profporta@gmail.com

Localita: Bari

 

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