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An Open-label, Uncontrolled, Multicenter Phase II Trial of MK-3475 (Pembrolizumab) in Children and Young Adults With Newly Diagnosed Classical Hodgkin Lymphoma With Inadequate (Slow Early) Response to Frontline Chemotherapy - MK-3475-667 (KEYNOTE 667)

Studio Clinico

Patologia: Linfomi

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: II

Linee di trattamento: Prima linea

Criteri di inclusione: 

- Group 1: Must have newly diagnosed, pathologically confirmed cHL at Stages IA, IB and IIA without bulky disease.
- Group 2: Must have newly diagnosed, pathologically confirmed cHL at Stages IIEB, IIIEA,IIIEB, IIIB, IVA and IVB ;
- Has measurable disease per investigator assessment;
- Male participant must agree to use approved contraception during treatment period and for at least 120 days (or longer, if required by the drug label of chemotherapy received by the participant on study) after the last dose of study treatment and refrain from donating sperm during this period;
- Female participants who are not pregnant or breastfeeding, and who are either not a woman of childbearing potential (WOCBP), or are a WOCBP who agrees to use approved contraception during the treatment period and for at least 120 days (or longer, if required by the drug label of chemotherapy received by the participant on study treatment);
- Performance status: Lansky Play-Performance Scale >=50 for children up to and including 16 years of age OR Karnfsky score >=50 for participants>16 years of age;
- Has adequate organ function

Criteri di esclusione: 

- Has undergone solid organ transplant at any time, or prior allogeneic hematopoietic stem cell transplantation within the last 5 years;
- WOCBP who has a positive urine pregnancy test within 72 hours before the first dose of study treatment;
- Baseline left ventricular ejection fraction value <50% or shortening fraction of <27%;
- Has received prior therapy with an anti-Programmed Death (PD)-1, anti-Programmed Death-Ligand 1 (PD-L1), or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor or has previously participated in a Merck pembrolizumab (MK-3475) clinical study;
- Has received any prior anti-cancer therapy, monoclonal antibody, chemotherapy, or an investigational agent or device before the first dose of study treatment, or has not recovered from Aes due to previously administered agents;
- Has received a live vaccine within 30 days prior to the first dose of pembrolizumab;
- 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 first dose of study treatment;
- Has a diagnosis of lymphocyte-predominant Hodgkin Lymphoma (HL);
- 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 pembrolizumab;
- Has radiographically detectable central nervous system metastases and/or carcinomatous meningitis as assessed by local site investigator at the time of diagnosis;
- Has severe hypersensitivity (>= Grade 3) to any study therapies including any excipients;
- Has an active autoimmune disease that has required systemic treatment in past 2 years;
- Has an active infection requiring systemic therapy;
- Has a known history of human immunodeficiency virus (HIV) infection;
- Has a known history of Hepatitis B or known active Hepatitis C virus infection;
- Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis;
- Has a known history of active tubercolosis.

Trattamento sperimentale: 

Pembrolizumab & Frontline CT

Trattamento di controllo: 

NA

Centri partecipanti

Nord Italia

Centro di Riferimento Oncologico
Via Franco Gallini 2 - 33081 Aviano - PN

 

Ospedale Infantile Regina Margherita di Torino
Piazza Polonia 94 - 10126 Torino - TO

Riferimento: Prof.ssa Franca Fagioli
Telefono: 0113135230
Email: franca.fagioli@unito.it

 

Centro Italia

Ospedale Pediatrico Bambin Gesù
Piazza Sant Onofrio 4 - 00165 Roma - RM

 

Università La Sapienza Policlinico Umberto I
Viale del Policlinico 155 - 00161 Roma - RM

 

Sud Italia e isole

AORN Santobono-Pausilipon
Via Della Croce Rossa 8 - 80122 Napoli - NA

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2017-001123-53

Data di inserimento: 21.05.2021

Promotore

Merck Sharp & Dohme Corp.

Principal Investigator ITALIA

Ospedale Pediatrico Bambino Gesù, Roma

Riferimento: Dr. Non disponibile

Telefono: 00000

Email: nd@nd.it

Localita: Roma

 

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