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MK-6482-011 - An Open-label, Randomized, Phase 3 Study of MK-6482 in Combination With Lenvatinib (MK-7902) vs Cabozantinib in Participants With Advanced Renal Cell Carcinoma Who Have Progressed After Prior Anti-PD-1/L1 Therapy

Studio Clinico

Patologia: Tumori del rene

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico


Fase di studio: III

Richiesta mandatoria di tessuto: 

Linee di trattamento: Seconda linea, Terza/N linea

Criteri di inclusione: 

  • Unresectable, locally advanced or metastatic clear cell renal cell carcinoma (RCC).
  • Disease progression on or after an anti-programmed cell death-1/ligand 1 (PD-1/L1) therapy as either first or second-line treatment for locally advanced/metastatic RCC or as adjuvant treatment with progression on or within 6 months of last dose.
  • Measurable disease per RECIST 1.1 criteria as assessed by local study investigator.
  • Karnofsky performance status (KPS) score of at least 70% assessed within 10 days before randomization.
  • Received no more than 2 prior systemic regimens.
  • Received only 1 prior antiPD-1/L1 therapy for adjuvant or locally advanced/metastatic RCC.
  • A male participant is eligible to participate if he is abstinent from heterosexual intercourse or agrees to use contraception during the intervention period and for at least 7 days after the last dose of belzutifan or lenvatinib in the belzutifan+lenvatinib arm, whichever occurs last, and 23 days after the last dose of cabozantinib.
  • A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: Not a woman of childbearing potential (WOCBP) or a WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 30 days after the last dose of study intervention in the belzutifan+ lenvatinib arm, or 120 days after the last dose of study intervention in the cabozantinib arm.
  • Adequately controlled blood pressure.
  • Adequate organ function.

Criteri di esclusione: 

  • A pulse oximeter reading <92% at rest, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen.
  • Known additional malignancy that is progressing or has required active treatment within the past 3 years except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy.
  • Known central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Clinically significant cardiac disease within 6 months of first dose of study intervention.
  • Prolongation of QTc interval to >480 ms.
  • Symptomatic pleural effusion (e.g.,cough, dyspnea, pleuritic chest pain) that is not clinically stable.
  • Pre-existing ≥Grade 3 gastrointestinal or nongastrointestinal fistula.
  • Moderate to severe hepatic impairment.
  • History of significant bleeding within 3 months before randomization.
  • History of solid organ transplantation.
  • Known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study.
  • Unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption (e.g., gastrectomy, partial bowel obstruction, malabsorption).
  • Known hypersensitivity or allergy to the active pharmaceutical ingredients or any component of the study intervention formulations.
  • Received colony-stimulating factors [eg, granulocyte colony-stimulating factor (G-CSF), granulocyte macrophage colony-stimulating factor (GMCSF) or recombinant erythropoietin (EPO)] within 28 days before randomization.
  • Prior treatment with belzutifan or another hypoxia-inducible factor (HIF)-2α inhibitor.
  • Prior treatment with lenvatinib.
  • Prior treatment with cabozantinib.
  • Currently participating in a study of an investigational agent or using an investigational device.
  • Active infection requiring systemic therapy.
  • History of human immunodeficiency virus (HIV) infection.
  • History of hepatitis B or known active hepatitis C infection.

Schema di trattamento: 

MK-6482 in Combination with Lenvatinib vs Cabozantinib

Trattamento sperimentale: 

Belzutifan + Lenvatinib

Trattamento di controllo: 


Obiettivi primari dello studio: 

  • Progression-Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) [Time Frame: Up to approximately 34 months]
    PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review will be presented.
  • Overall Survival (OS) [Time Frame: Up to approximately 44 months]
    OS is defined as time from randomization to death due to any cause.

Data di inizio dell'arruolamento: 01.11.2022

Data di fine dell'arruolamento: 31.07.2023

Centri partecipanti

Nord Italia

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

Riferimento: Dr. Ugo De Giorgi
Telefono: 0543739100


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

Riferimento: Dr. Giuseppe Procopio
Telefono: 0223904450


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

Riferimento: Prof. Andrea Necchi
Telefono: 0226435789


Istituto Clinico Humanitas Rozzano
Via Manzoni 56 - 20089 Rozzano - MI
N.B.: Arruolamento pazienti non ancora attivo

Riferimento: Prof. Armando Santoro
Telefono: 0282244080


Fondazione Salvatore Maugeri-IRCCS
Via Salvatore Maugeri 4 - 27100 Pavia - PV
Dipartimento di Oncologia Medica


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

Riferimento: Prof.ssa Consuelo Buttigliero


AOUI Verona - Borgo Trento
Piazzale Aristide Stefani 1 - 37126 Verona - VR
UOC Oncologia

Riferimento: Dr. Andrea Zivi


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


Fondazione Policlinico A. Gemelli
Largo Agostino Gemelli 8 - 00168 Roma - RM
UOC Oncologia Medica - N.B.: Arruolamento pazienti non ancora attivo

Riferimento: Dr. Roberto Iacovelli
Telefono: 0630154953


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

Riferimento: Dr. Sergio Bracarda
Telefono: 0744205631


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

Informazioni Generali


Numero di iscrizione a registro: 2020-002075-35

Data di inserimento: 05.07.2022


Merck Sharp & Dohme LLC

Principal Investigator ITALIA

Azienda Ospedaliera S. Maria di Terni

Riferimento: Dr. Sergio Bracarda

Telefono: 0744205631


Localita: Terni


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