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MK-6482-012 - An Open-label, Randomized Phase 3 Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or MK-1308A in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, as First-Line Treatment in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)

Studio Clinico

Patologia: Tumori del rene

Osservazionale-Sperimentale: Sperimentale

Randomizzato: 

Fase di studio: III

Richiesta mandatoria di tessuto: 

Linee di trattamento: Prima linea

Criteri di inclusione: 

  • Has histologically confirmed diagnosis of RCC with clear cell component
  • Has received no prior systemic therapy for advanced ccRCC
  • Male participants are abstinent from heterosexual intercourse or agree to use contraception during and for at least 7 days after last dose of study intervention with belzutifan and lenvatinib
  • Female participants are not pregnant or breastfeeding and are either not a woman of child-bearing potential (WOCBP) or use a contraceptive method that is highly effective or are abstinent from heterosexual intercourse during the intervention period and for at least 120 days after pembrolizumab or pembrolizumab/quavonlimab or for at least 30 days after last dose of lenvatinib or belzutifan, whichever occurs last
  • Has adequately controlled blood pressure with or without antihypertensive medications
  • Has adequate organ function
  • Participants receiving bone resorptive therapy must have therapy initiated at least 2 weeks prior to randomization/allocation

Criteri di esclusione: 

  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
  • Has had major surgery, other than nephrectomy within 4 weeks prior to randomization
  • Has known central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has received prior radiotherapy within 2 weeks prior to first dose of study intervention
  • Has hypoxia or requires intermittent supplemental oxygen or requires chronic supplemental oxygen
  • Has clinically significant cardiac disease within 12 months from first dose of study intervention
  • Has a history of interstitial lung disease
  • Has symptomatic pleural effusion; a participant who is clinically stable following treatment of this condition is eligible
  • Has preexisting gastrointestinal or non-gastrointestinal fistula
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment
  • Has a known psychiatric or substance abuse disorder that would interfere with requirements of the study
  • Has received a live or live-attenuated vaccine within 30 days before the first dose of study drug; killed vaccines are allowed
  • Has an active autoimmune disease that has required systemic treatment in the past 2 years
  • Has a history of noninfectious pneumonitis that required steroids or has current pneumonitis
  • Has an active infection requiring systemic therapy
  • Has a known history of human immunodeficiency virus (HIV) infection
  • Has a known history of Hepatitis B
  • Has radiographic evidence of intratumoral cavitation, encasement or invasion of a major blood vessel
  • Has clinically significant history of bleeding within 3 months prior to randomization
  • Has had an allogenic tissue/solid organ transplant

Trattamento sperimentale: 

Experimental 1) Pembrolizumab + Belzutifan + Lenvatinib
Experimental 2) Pembrolizumab/Quavonlimab + Lenvatinib

Trattamento di controllo: 

Active comparator: Pembrolizumab + Lenvatinib

Obiettivi primari dello studio: 

  • Progression Free Survival (PFS) According to 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 46 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 BICR based on RECIST 1.1 will be presented.
  • Overall Survival (OS) [ Time Frame: Up to approximately 66 months ]
    OS is defined as the time from randomization to death due to any cause.

Obiettivi secondari dello studio: 

  • Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR [ Time Frame: Up to approximately 46 months ]
    ORR is defined as the percentage of participants who have a complete response (CR: disappearance of all target lesions) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience a CR or PR as assessed by BICR based on RECIST 1.1 will be presented.
  • Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR [ Time Frame: Up to approximately 66 months ]
    For participants who demonstrate a confirmed CR (disappearance of all target lesions) or confirmed PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until PD or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as at least a 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. The DOR as assessed by BICR based on RECIST 1.1 will be presented.
  • Number of Participants Who Experienced At least One Adverse Event (AE) [ Time Frame: Up to approximately 66 months ]
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience at least one AE will be presented.
  • Number of Participants Who Discontinue Study Treatment Due to an AE [ Time Frame: Up to approximately 66 months ]
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be presented.

Data di inizio dell'arruolamento: 30.11.2021

Data di fine dell'arruolamento: 31.10.2023

Centri partecipanti

Nord Italia

IRCCS Istituto Nazionale dei Tumori
Via Venezian 1 - 20133 Milano - MI

 

A.O.U. Policlinico di Modena
Via del Pozzo 71 - 41100 Modena - MO

 

Centro Italia

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

 

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

 

Sud Italia e isole

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

 

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

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2020-002216-52

Data di inserimento: 24.05.2022

Promotore

Merck Sharp & Dohme LLC

Principal Investigator ITALIA

Riferimento: Dr. Informazione non disponibile

Telefono: 00000

Email: nd@nd.it

Localita: nd

 

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