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An Open-label, Randomized Phase 3 Study of MK-6482 Versus Everolimus in Participants With Advanced Renal Cell Carcinoma That Has Progressed After Prior PD-1/L1 and VEGF-Targeted Therapies - MK6482-005

Studio Clinico

Patologia: Tumori del rene

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: III

Linee di trattamento: Seconda linea

Criteri di inclusione: 

- Has unresectable, locally advanced or metastatic clear cell renal cell carcinoma (RCC)
- Has had disease progression on or after having received systemic treatment for locally advanced or metastatic RCC with both - Programmed cell death 1 ligand 1 (PD-1/L1) checkpoint inhibitor and a vascular endothelial growth factor - tyrosine kinase inhibitor (VEGF-TKI) in sequence or in combination.
- Has received no more than 3 prior systemic regimens for locally advanced or 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 5 days after the last dose of study intervention
- 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 for those randomized to belzutifan and for at least 8 weeks after the last dose of study intervention for those randomized to everolimus.
- The participant (or legally acceptable representative if applicable) provides written informed consent for the study.
- Has adequate organ function

Criteri di esclusione: 

- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. (Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ [e.g., breast carcinoma, cervical cancer in situ] that have undergone potentially curative therapy are not excluded.)
- Has known central nervous system (CNS) metastases and/or carcinomatous meningitis. (Participants with previously treated brain metastases may participate provided they are radiologically stable for at least 4 weeks (28 days) by repeat imaging.)
- Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months from Day 1 of study drug administration, or New York Heart Association Class III or IV congestive heart failure. (Medically controlled arrhythmia stable on medication is permitted.)
- Has poorly controlled hypertension defined as systolic blood pressure (SBP) ≥150 mm Hg and/or diastolic blood pressure (DBP) ≥90 mm Hg.
- Has moderate to severe hepatic impairment (Child-Pugh B or C).
- Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study.
- Is unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption (e.g., gastrectomy, partial bowel obstruction, malabsorption).
- Has known hypersensitivity or allergy to the active pharmaceutical ingredient or any component of the study intervention (belzutifan or everolimus) formulations.
- Has received prior treatment with belzutifan or another hypoxia inducible factor 2α (HIF-2α inhibitor).
- Has received prior treatment with everolimus or any other specific or selective target of rapamycin complex 1 (TORC1)/ phosphatidylinositol 3-kinase (PI3K)/ protein kinase B (AKT) inhibitor (e.g., temsirolimus) in the advanced disease setting.
- Has received any type of systemic anticancer antibody (including investigational antibody) within 4 weeks before randomization.
- Has received prior radiotherapy within 2 weeks prior to randomization.
- Has had major surgery within 3 weeks prior to randomization.
- Has received a live vaccine within 30 days prior to randomization. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines are live attenuated vaccines and are not allowed.
- Is currently receiving either strong (e.g., itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate (e.g., ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil) inhibitors of cytochrome P450 3A4 (CYP3A4) that cannot be discontinued for the duration of the study.
- Is currently receiving either strong (phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate (e.g., bosentan, efavirenz, modafinil) inducers of CYP3A4 that cannot be discontinued for the duration of the study.
- Is currently participating in a study of an investigational agent or is currently using an investigational device.
- Has an active infection requiring systemic therapy.
- Has active bacillus tuberculosis (TB).
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization.
- Has a known history of human immunodeficiency virus (HIV) infection. (Testing for HIV at screening is only required if mandated by local health authority.
- Has a known history of Hepatitis B virus (HBV) (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (HCV) (defined as HCV ribonucleic acid [RNA] [qualitative] is detected) infection.

Trattamento sperimentale: 

MK6482 (Belzutifan)

Trattamento di controllo: 

Everolimus

Obiettivi primari dello studio: 

The primary objective of this study is to compare belzutifan to everolimus with respect to 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) and to compare everolimus with respect to overall survival (OS). The hypothesis is that belzutifan is superior to everolimus with respect to PFS and OS.

Centri partecipanti

Nord Italia

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

 

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

Riferimento: Dr. Giuseppe Procopio
Telefono: 0223904450
Email: giuseppe.procopio@istitutotumori.mi.it

 

A.O.U. Policlinico di Modena
Via del Pozzo 71 - 41100 Modena - MO
Divisione di Oncologia Medica - Gruppo Oncologico Italiano di Ricerca Clinica

 

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

 

AOUI Verona - Borgo Trento
Piazzale Aristide Stefani 1 - 37126 Verona - VR
U.O.C. Oncologia

 

Centro Italia

Istituto Toscano Tumori Ospedale San Donato
Via Pietro Nenni 20 - 52100 Arezzo - AR
U.O.C. Oncologia Medica

 

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

 

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

 

Sud Italia e isole

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

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2019-003444-72

Data di inserimento: 15.06.2021

Promotore

Merck Sharp & Dohme Corp.

CRO

NA

Principal Investigator ITALIA

IRCCS Istituti Clinici Scientifici Maugeri, Pavia

Riferimento: Dr.ssa Info non disponibile

Telefono: 00000

Email: nd@nd.it

Localita: Pavia

 

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