B-cell Lymphoma is an aggressive and rare cancer of a type of immune cell (a white blood cell responsible for fighting infections). The purpose of this study is to assess the safety and tolerability of epcoritamab in combination with anti-neoplastic agents in adult participants with Non-Hodgkin lymphoma (NHL). Adverse events and change in disease activity will be assessed. Epcoritamab is an investigational drug being developed for the treatment of NHL. Study doctors put the participants in groups called treatment arms. The combination of epcoritamab with anti-neoplastic agents will be explored. Each treatment arm receives a different treatment combination depending on eligibility. Approximately 496 adult participants with NHL will be enrolled in 100 sites globally. In both the dose escalation and dose expansion arms participants will receive subcutaneous (SC) epcoritamab in 28 day, 21 day, or 56 day cycles dependent on the arm in combination with the anti-neoplastic agents described below: 1: Oral lenalidomide in participants (PPTS) with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL); 2: Oral ibrutinib and oral lenalidomide in PPTS with R/R DLBCL; 3: Intravenous (IV) polatuzumab vedotin, IV rituximab, IV cyclophosphamide, IV doxorubicin hydrochloride (HCl), and oral prednisone (pola-R-CHP) in PPTS with newly diagnosed treatment-naïve DLBCL, or completion of treatment in 3B; 4: Oral CC-99282 in PPTS with R/R DLBCL; 5: Oral CC-99282 in PPTS with R/R follicular lymphoma (FL); 6A: Oral ibrutinib in PPTS with R/R mantle cell lymphoma (MCL). There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
496
Subcutaneous Injection (SC)
Oral; Capsule
Oral; Capsule
Intravenous (IV); Injection
IV; Injection
IV; Injection
Oral; Tablet
IV; Injection
Oral; Capsule
The University of Arizona Cancer Center - North Campus /ID# 242219
Tucson, Arizona, United States
COMPLETEDYale University School of Medicine /ID# 242089
New Haven, Connecticut, United States
RECRUITINGChristiana Care Health Service /ID# 242301
Newark, Delaware, United States
RECRUITINGTampa General Hospital /ID# 246748
Tampa, Florida, United States
Number of Participants with Dose-Limiting Toxicities (DLT)
DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.
Time frame: Up to Approximately 5 Years
Best Overall Response (BOR) per Investigator
BOR is defined as the percentage of participants who achieved best overall response of CR or PR by Lugano 2014 criteria as assessed by the investigator.
Time frame: Up to Approximately 5 Years
Duration of response (DOR) per Investigator
DOR is defined for participants who achieved best overall response of CR or PR ('responders'), as the time in months from initial CR/PR to the earliest occurrence of radiographic progression determined by Lugano 2014 criteria as assessed by the investigator, or death from any cause.
Time frame: Up to Approximately 5 Years
Number of Participants with Progression-free survival (PFS)
PFS is defined as the time in months from the first dose of study drug to the earliest occurrence of disease progression determined by Lugano 2014 criteria as assessed by investigator, or death from any cause.
Time frame: Up to Approximately 5 Years
Percentage of Participants with Complete Response (CR)
CR is defined as the percentage of participantswho achieved best overall response of CR determined by Lugano 2014 criteria as assessed by investigator.
Time frame: Up to Approximately 5 Years
Time-to-response (TTR)
TTR is defined as the number of months from the date of first dose to the date of best overall response of CR or PR ('responders') determined by Lugano 2014 criteria as assessed by investigator.
Time frame: Up to Approximately 5 Years
Time to Next Antilymphoma Therapy (TTNT)
Time to next antilymphoma therapy.
Time frame: Up to Approximately 5 Years
Rate of Minimal Residual Disease (MRD) Negativity
MRD is defined as the percentage of participants with assessment of the minimal residual disease.
Time frame: Up to Approximately 5 Years
Overall Survival (OS)
(OS) is defined as the time in months from first dose of epcoritamab to death from any cause.
Time frame: Up to Approximately 5 Years
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Winship Cancer Institute of Emory University /ID# 242153
Atlanta, Georgia, United States
COMPLETEDUniversity of Maryland, Baltimore /ID# 242218
Baltimore, Maryland, United States
RECRUITINGAlliance for Multispecialty Research (AMR) - Kansas City /ID# 242144
Kansas City, Missouri, United States
COMPLETEDNorthwell Health - Monter Cancer Center /ID# 245435
Lake Success, New York, United States
RECRUITINGIcahn School of Medicine at Mount Sinai /ID# 242123
New York, New York, United States
RECRUITINGNovant Health Presbyterian Medical Center /ID# 242148
Charlotte, North Carolina, United States
COMPLETED...and 65 more locations