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MK3475-C11 - Phase 2 Study of Pembrolizumab and Chemotherapy in Patients With Newly Diagnosed Classical Hodgkin Lymphoma (KEYNOTE-C11)

Studio Clinico

Patologia: Linfomi

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: II

Richiesta mandatoria di tessuto: 

Linee di trattamento: Prima linea

Criteri di inclusione: 

  • Has a histologically confirmed diagnosis of Ann Arbor Stage III or IV classical Hodgkin Lymphoma (cHL). Stage I and II participants may be enrolled, but must have at least one National Comprehensive Cancer Network (NCCN) unfavorable risk factor per protocol
  • Has measurable 2-fluorodeoxyglucose (FDG)-avid disease based on investigator assessment according to Lugano 2014 response criteria
  • Has not received prior radiation therapy, chemotherapy, immunotherapy, or other systemic therapy for the treatment of cHL before the first dose of study intervention
  • Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 assessed within 7 days before the start of study intervention

Criteri di esclusione: 

  • Has confirmed nodular lymphocyte-predominant Hodgkin Lymphoma (HL)
  • Has an uncontrolled intercurrent cardiovascular illness
  • Has received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-programmed cell death ligand 1 protein (PD-L1), or anti- programmed cell death ligand 2 protein (PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor
  • Has received or is expected to receive a live or live-attenuated vaccine within 30 days before the first dose of study intervention
  • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication
  • Has a known additional malignancy that is progressing or has required active treatment within the past 5 years
  • Has radiographically detectable central nervous system metastases and/or carcinomatous meningitis
  • Has an active autoimmune disease that has required systemic treatment in past 2 years
  • Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
  • Has a history or current evidence of pulmonary fibrosis
  • Has had an allogenic tissue/solid organ transplant

Numero di pazienti previsti: 

140

Schema di trattamento: 

MK3475, AVD, escBEACOPP if PET 3 positive

Trattamento sperimentale: 

3 cycles MK3475 followed by 2 cycles AVD and depending on PET3 4 cycles AVD or 4 cycles escBEACOPP followed by 4 cycles MK3475 400mg ( Q6W)

Trattamento di controllo: 

NA

Obiettivi primari dello studio: 

CR at the end of study intervention as assessed by ICR per Lugano 2014 Response Criteria

Obiettivi secondari dello studio: 

1. CR at teh end of study intervaention as assessed by nvestogator per Lugano 2014 Response criteria
2.DOR as assesses by ICR per Lugano 2014 Response Criteria
3. PET negativity by ICR per FDG-PET 5-POINT SCALE after Pembrolizumab monotherapy
4. PET negativity by ICR per FDG-PET 5 POINT SCALE after Pembro and chemotherpay
5. Number of participants who experienced an AE
6. Number of partIcipants who discontinued Study treatment due to an AE

Data di inizio dell'arruolamento: 23.09.2021

Data di fine dell'arruolamento: 20.04.2023

Centri partecipanti

Nord Italia

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

Riferimento: Prof. Pierluigi Zinzani
Telefono: 0512143680
Email: pierluigi.zinzani@unibo.it

 

ASST Spedali Civili di Brescia
Piazzale Spedali Civili 1 - 25123 Brescia - BS

 

Ospedale Niguarda Ca' Granda
Piazza dell'Ospedale Maggiore 3 - 20162 Milano - MI

 

Centro Italia

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

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2021-001244-95

Data di inserimento: 10.05.2022

Promotore

Merck Sharp & Dohme LLC

CRO

/

Principal Investigator ITALIA

ASST Grande Ospedale Metropolitano Niguarda

Riferimento: Dr. Informazione non disponibile

Telefono: 00000

Email: nd@nd.it

Localita: Milano

 

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