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Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC) - (MK-7339-010/KEYLYNK-010)

Studio Clinico

Patologia: Carcinoma della prostata

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: III

Richiesta mandatoria di tessuto: 

Linee di trattamento: Terza/N linea

Criteri di inclusione: 

  • Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology
  • Has prostate cancer progression while receiving androgen deprivation therapy (or post bilateral orchiectomy) within 6 months prior to screening
  • Has current evidence of metastatic disease documented by bone lesions on bone scan and/or soft tissue disease shown by computed tomography/magnetic resonance imaging (CT/MRI)
  • Has disease that progressed during prior treatment with abiraterone acetate OR enzalutamide, but not both, for mCRPC
  • Has received no more than 1 previous chemotherapy regimen for mCRPC and have had PD during treatment
  • Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<2.0 nM)
  • If receiving bone resorptive therapy, including but not limited to bisphosphonates or denosumab, must have been receiving stable doses prior to randomization
  • Must agree to refrain from donating sperm during the intervention period and for at least 180 days thereafter PLUS Be abstinent from heterosexual intercourse OR Agree to use contraception unless confirmed to be azoospermic AND Also agree to use a male condom when engaging in any activity that allows passage of ejaculate to another person of any sex
  • Has provided tumor tissue from a fresh core or excisional biopsy (obtained within 12 months of screening) from soft tissue not previously irradiated. Samples from tumors progressing at a prior site of radiation are allowed. Participants with bone-only or bone-predominant disease may provide a bone biopsy sample
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization

Criteri di esclusione: 

  • Has a known additional malignancy that is progressing or has required active treatment in the last 3 years
  • Has an active autoimmune disease that has required systemic treatment in the past 2 years
  • Has a history of (noninfectious) pneumonitis requiring steroids, or has current pneumonitis
  • Has known active human immunodeficiency virus (HIV), hepatitis B virus (e.g., hepatitis B surface antigen reactive) or hepatitis C virus (HCV) infection (e.g., HCV RNA [qualitative] is detected)
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Has a history of seizure or any condition that may predispose to seizure
  • Has a history of loss of consciousness within 12 months of screening
  • Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or has features suggestive of MDS/AML
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
  • Has severe (Grade >3) hypersensitivity to pembrolizumab and/or any of its excipients
  • Has known hypersensitivity to the components or excipients in olaparib, abiraterone acetate, prednisone or prednisolone, or enzalutamide
  • Has symptomatic congestive heart failure (New York Heart Association Class III or IV heart disease)
  • Has received an anticancer monoclonal antibody (mAb) prior to randomization
  • Has received prior treatment with olaparib or any other PARP inhibitor
  • Has received prior treatment with apalutamide or darolutamide
  • Has used herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA (e.g., saw palmetto) prior to the date of randomization
  • Has received prior treatment with radium or other therapeutic radiopharmaceuticals for prostate cancer
  • Has received prior treatment with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent, or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, or CD137)
  • Is currently receiving either strong or moderate inhibitors of cytochrome P450 [CYP] (CYP3A4) that cannot be discontinued for the duration of the study
  • Has received a previous allogenic bone marrow transplant or double umbilical cord transplantation (dUCBT)
  • Has received a live vaccine within 30 days prior to the date of randomization
  • Is currently participating in or has participated in a study of an investigational agent, or has used an investigational device, within 4 weeks prior to the date of randomization
  • Has a bone 'superscan'
  • Is expecting to father children within the projected duration of the study, starting with the screening visit through 180 days after the last dose of study interventionHas a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy

Schema di trattamento: 

Pembrolizumab 200 mg + Olaparib 300 mg BID vs Abiraterone Acetato 1000 mg + Prednisone 10 mg oppure Enzalutamide 160 mg

Trattamento sperimentale: 

Pembrolizumab + Olaparib

Trattamento di controllo: 

Abiraterone acetato + Prednisone oppure Enzalutamide

Obiettivi primari dello studio: 

1) Overall Survival (OS)
2) Radiographic Progression-Free Survival (rPFS) Per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review

Obiettivi secondari dello studio: 

1) Time to Initiation of the First Subsequent Anticancer Therapy or Death
2) Objective Response Rate (ORR) Per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review
3) Duration of Response (DOR) Per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review
4) Time to Prostate-Specific Antigen (PSA) Progression
5) Time to First Symptomatic Skeletal-Related Event (SSRE)
6) Time to Radiographic Soft Tissue Progression Per Soft Tissue Rules of Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review
7) Time to Pain Progression (TTPP) as Assessed by Brief Pain Inventory-Short Form (BPI-SF) Item 3 ('Worst Pain in 24 Hours') and Opiate Analgesic Use (Analgesic Quantification Algorithm [AQA] Score)
8) Number of Participants Who Experience an Adverse Event (AE)
9)Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)

Data di inizio dell'arruolamento: 30.04.2019

Data di fine dell'arruolamento: 28.10.2020

Centri partecipanti

Nord Italia

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

 

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

 

Presidio ospedaliero di Santa Chiara
Largo Medaglie d'Oro 1 - 38122 Trento - TN

 

Centro Italia

Azienda Ospedaliera San Camillo Forlanini
Via Portuense 332 - 00149 Roma - RM

 

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

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

 

Sud Italia e isole

A.O. per l’Emergenza Cannizzaro di Catania
Via Messina 829 - 95126 Catania - CT

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2018-004118-16

Data di inserimento: 18.09.2019

Promotore

Merck Sharp & Dohme Corp.

CRO

NA

Principal Investigator ITALIA

Azienda Ospedaliera Santa Maria - Terni

Riferimento: Dr. Sergio Bracarda

Telefono: 0744205631

Email: s.bracarda@aospterni.it

Localita: Terni

 

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