Epcoritamab
DrugSubcutaneous Injection (SC)
Other names: ABBV-GMAB-3013
NCT Number: NCT05451810
B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). Classic Follicular Lymphoma is a slow-growing type of non-Hodgkin lymphoma. The purpose of this study is to assess the safety of epcoritamab in adult participants in relapsed or refractory (R/R) diffuse large b-cell lymphoma (DLBCL) who have received at least 1 prior line of systemic antilymphoma therapy including at least 1 anti-CD20 monoclonal antibody-containing therapy or R/R classic follicular lymphoma (cFL). Adverse events will be assessed.
Epcoritamab is an investigational drug being developed for the treatment of R/R DLBCL and R/R cFL. Study doctors will assess participants in a monotherapy treatment arm of epcoritamab. Participants will receive escalating doses of epcoritamab, until full dose is achieved. Approximately 184 adult participants with R/R DLBCL and R/R cFL will be enrolled in the study in approximately 80 sites in the United States of America.
Participants will receive escalating doses of subcutaneous epcoritamab, until full dose is achieved, in 28-day cycles.
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 2
Pan American Center for Oncology Trials, LLC /ID# 254952, Rio Piedras, Puerto Rico
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
-- Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL):
--- Classic FL (cFL) (previously FL grade 1, 2, or 3a) without clinical or pathological evidence of transformation;
Exclusion criteria
Subcutaneous Injection (SC)
Other names: ABBV-GMAB-3013
Time frame: Up to 3 Months
Cytokine Release Syndrome events will be graded using American Society for Transplantation and Cellular Therapy (ASTCT), with a higher grade indicating higher severity.
Time frame: Up to 3 Months
ICANS events will be graded using ASTCT, with a higher grade indicating higher severity.
Time frame: Up to 3 Months
Ntox is defined as the percentage of participants who developed at least 1 Grade 3 or higher Ntox since the initiation of epcoritamab treatment.
Time frame: Up to 3 Months
BOR is defined as the percentage of participants who achieved best overall response of complete response (CR) or partial response (PR) determined by Lugano 2014 criteria as assessed by investigators.
Time frame: Up to 3 Months
Complete response is defined as the percentage of participants who achieved best overall response of CR determined by Lugano 2014 criteria as assessed by investigator.
Time frame: Up to 3 Months
Treatment-emergent events (TEAEs) are defined as any event that began or worsened in severity after the first dose of study drug.
Time frame: Up to 3 Months
Treatment-emergent events (TEAEs) are defined as any event that began or worsened in severity after the first dose of study drug.
Time frame: Up to 3 Months
A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
Time frame: Up to 3 Months
A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
Time frame: Up to 3 Months
Median time to onset of CRS of Grade 3 or higher.
Time frame: Up to 3 Months
Median time to resolution of CRS of Grade 3 or higher.
Time frame: Up to 3 Months
Median time to onset of ICANS of Grade 3 or higher.
Time frame: Up to 3 Months
Median time to resolution of ICANS of Grade 3 or higher.
Time frame: Up to 3 Months
Median time to onset of Ntox of Grade 3 or higher.
Time frame: Up to 3 Months
Median time to resolution of Ntox of Grade 3 or higher.
Time frame: Up to 3 Months
An adverse event is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Time frame: Up to 3 Months
Percentage of participants receiving various interventions for the management of CRS after the first full dose of epcoritamab.
Time frame: Up to 3 Months
Percentage of participants receiving various interventions for the management of ICANS after the first full dose of epcoritamab.
Time frame: Up to 3 Months
Percentage of participants receiving various interventions for the management of Ntox after the first full dose of epcoritamab.
Time frame: Up to 3 Months
Duration of response is defined for participants who achieved BOR of CR or PR ('responders'), as the time in months from initial CR/PR 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 3 Months
Progression-free survival 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 3 Months
Overall survival is defined for as the time in months from first dose of epcoritamab to death from any cause.
Time frame: Up to 3 Months
Time to response is defined for participants who achieved BOR of CR or PR ('responders') determined by Lugano 2014 criteria as assessed by investigator, as the time in months from first dose of study drug to initial CR/PR.
Time frame: Up to 3 Months
The duration of complete response is defined for participants who achieved BOR of CR (Complete Responders), as the duration from the first CR response to the earliest date of disease progression determined per Lugano 2014 criteria, as assessed by the investigator, or death, whichever occurs first.
Time frame: Up to 3 Months
Time to next treatment is defined as the time from the date of the first dose of study drug to the start of new non-protocol-specified treatment or death from any cause.
Genmab
Industry
A Phase 2, Open-Label Trial to Evaluate Safety of Epcoritamab Monotherapy in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Classic Follicular Lymphoma (Previously Grade 1-3a) When Administered in the Outpatient Setting
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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