MK-2140-004 - A Phase 2 Open-label Clinical Study to Evaluate the Efficacy and Safety of Zilovertamab Vedotin (MK-2140) in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Studio Clinico

Patologia: Linfomi

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: II

Richiesta mandatoria di tessuto: Sì

Linee di trattamento: Terza/N linea

Criteri di inclusione: 

· Has relapsed or refractory (rr) DLBCL; has progressed after at least 2 lines of prior therapy; and has progressed after auto- stem cell transplant (SCT) or are auto-SCT ineligible. Must have received prior multiagent regimen that includes an alkylating agent, anthracycline, and anti-CD20 (cluster of differentiation 20) monoclonal antibody.
· Has histologically confirmed diagnosis of DLBCL.
· Has radiographically measurable DLBCL per the Lugano Response Criteria.
· Should either be post- chimeric antigen receptor T cell therapy (CAR-T) failure or ineligible for CAR-T (for any reason).
· Life expectancy of at least 3 months.
· Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before time of enrollment.
· Has adequate organ function.

Criteri di esclusione: 

· Has received a diagnosis of Primary mediastinal B-cell lymphoma (PMBCL).
· Has undergone solid organ transplant at any time.
· Has a history of any clinically significant cardiovascular conditions within 6 months of screening or serious cardiac arrhythmia requiring medication.
· Has known history of liver cirrhosis.
· Has pericardial effusion or clinically significant pleural effusion.
· Has ongoing Grade >1 peripheral neuropathy.
· Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.
· Transformed DLBCL from indolent lymphoma.
· In participants with prior allo-SCT, acute graft versus host disease (GVHD) or ongoing evidence of chronic GVHD.
· Has received prior systemic anticancer therapy, including investigational agents within 4 weeks prior to the first dose of study intervention.
· Has received prior radiotherapy within 4 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
· Has ongoing corticosteroid therapy (exceeding 30 mg daily of prednisone equivalent).
· Has received 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 known active central nervous system (CNS) lymphoma involvement or active CNS involvement by lymphoma.
· 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 (HCV)

Numero di pazienti previsti: 

100

Trattamento sperimentale: 

Zilovertamab Vedotin (MK-2140)

Trattamento di controllo: 

NA

Obiettivi primari dello studio: 

ORR per Lugano 2014 Response Criteria

Obiettivi secondari dello studio: 

1. DOR per Lugano 2014 Response criteria
2. Number of participants who experienced an AE
3. Number of PartIcIpants who discontinued study treatment due to an AE

Data di inizio dell'arruolamento: 31.12.2021

Periodo previsto di arruolamento: 10

Data di fine dell'arruolamento: 10.10.2022

Centri partecipanti

Nord Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2021-003397-32

Data di inserimento: 09.05.2022

Promotore

Merck Sharp & Dohme LLC

CRO

/

Principal Investigator ITALIA

Fondazione IRCCS Istituto Nazionale dei Tumori 'G. Pascale' (Struttura Complessa di Ematologia)

Riferimento: Dr. Informazione non disponibile

Telefono: 00000

Email: nd@nd.it

Localita: Napoli