Fase di studio: II Randomizzato
Linee di trattamento: Seconda linea, Terza/N linea
Criteri di inclusione:
For aggressive B-cell malignancies MCL:
- Has histologically confirmed biopsy according to the 2016 World Health Organization (WHO) classification of neoplasms of the hematopoietic and lymphoid tissues and has relapsed or refractory disease after at least 2 prior systemic therapies including a Bruton's tyrosine kinase inhibition/inhibitor(s) (BTKi), and is post chimeric antigen receptor T (CAR-T) cell therapy or is ineligible for CAR-T cell therapy.
For aggressive B-cell malignancies MCL Cohort C:
- Has histologically confirmed biopsy according to the 2016 World Health Organization (WHO) classification of neoplasms of the hematopoietic and lymphoid tissues and has relapsed or refractory disease after at least 1 prior systemic therapy and has no prior exposure to a non-covalent BTKi.
For aggressive B-cell malignancies Richter transformation lymphoma (RTL):
- Has histologically confirmed biopsy according to the 2016 World Health Organization (WHO) classification of neoplasms of the hematopoietic and lymphoid tissues and has relapsed or refractory disease.
For indolent B-cell malignancies FL and CLL:
- Has histologically confirmed biopsy and has relapsed or refractory disease after at least 2 prior systemic therapies and no other available therapy.
- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization/allocation.
- Have an ECOG performance status of 0 to 2 assessed within 7 days before cycle 1 day 1.
Criteri di esclusione:
- Has received solid organ transplant at any time.
- Has clinically significant (ie, active) cardiovascular disease: cerebral vascular accident/stroke (<6 months prior to enrollment), myocardial infarction (<6 months prior to enrollment), unstable angina (<6 months prior to enrollment), congestive heart failure (New York Heart Association Classification Class ≥II), or serious cardiac arrhythmia requiring medication.
- Has pericardial effusion or clinically significant pleural effusion.
- Has ongoing Grade >1 peripheral neuropathy.
- Has a demyelinating form of Charcot-Marie-Tooth disease.
- Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.
- Participants with FL who have transformed to a more aggressive type of lymphoma.
- Has received prior systemic anticancer therapy, including investigational agents, within 5 half-lives or 4 weeks (if prior therapy was a monoclonal antibodies) or 2 weeks (small molecules like kinase inhibitors) prior to the first dose of study intervention.
- Has received prior radiotherapy within 28 days of start of study intervention. Participants must have recovered from all radiation-related toxicities.
- 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.
- 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.
- Active HBV or hepatitis C virus (HCV) infection.
- For Cohort C only: has any clinically significant gastrointestinal abnormalities that might alter absorption.
MK2140 and MK-1026
Trattamento di controllo:
Ziloveramab vedotin and Nemtabrutinib
AO SS Antonio e Biagio e C. Arrigo
Via Venezia 16 - 15100 Alessandria - AL
Ospedale S.Orsola Malpighi, Università di Bologna
Via Pietro Albertoni 15 - 40138 Bologna - BO
Istituto di Ematologia e Oncologia Medica “L. e A. Seràgnoli”
Riferimento: Prof. Pierluigi Zinzani
Istituto Clinico Humanitas Rozzano
Via Manzoni 56 - 20089 Rozzano - MI
UO di Oncologia Medica ed Ematologia
Riferimento: Prof. Armando Santoro
Numero di iscrizione a registro: 2021-004450-36
Data di inserimento: 16.11.2023
Merck Sharp & Dohme LLC
Istituto Clinico Humanitas - Rozzano
Riferimento: Prof. Armando Santoro
Localita: Rozzano (MI)