Outpatient Epcoritamab as 2L in NTE R/R DLBCL
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
The purpose of this study is to measure the efficacy of the study drug, epcoritamab, in participants with relapsed/refractory large B-cell lymphoma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS)
High grade B-cell lymphoma (HGBCL) with rearrangements of MYC and BCL2 and/or BCL6
HGBCL NOS
EBV+ DLBCL
Disqualifiers
Participant must not have used an investigational drug or approved systemic lymphoma therapy within 28 days preceding the first dose of study drug. Steroids for lymphoma disease control are permitted but must be stopped at least 7 days prior to the first dose of study drug.
Participants must not have received prior CD20/CD3 bispecific antibody.
Participants must not have received prior autologous or allogeneic stem cell transplant.
Participants must not have received prior anti-CD19 CAR T-cell therapy.
Trial design
Design model
Single group
Treatments tested in this trial
Epcoritamab
DrugBispecific IgG1 antibody
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: EpcoritamabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
12-month progression free survival (PFS)
The time from registration to the earlier of progression or death due to any cause and will be defined as the percent of patients alive and progression-free at 12 months. Participants alive without disease progression are censored at date of last disease evaluation.
Time frame
Day 1 until date of first documented disease progression or date of death from any cause, whichever came first, assessed up to 12 months after initial dose of study treatment.Secondary outcomes
1
Complete Response Rate
The proportion of subjects achieving an objective response of complete response (CR) according to the Lugano Classification, prior to start of another non-study anticancer therapy.
Time frame
Day 1 to 24 months post treatment2
Overall Response Rate
The proportion of subjects achieving an objective response of complete response (CR) or partial response (PR) according to the Lugano Classification, prior to start of another non-study anticancer therapy.
Time frame
Day 1 to 24 months post treatment3
Median Duration of Response
The time from first response to disease progression or death, and will be summarized using Kaplan-Meier estimates.
Time frame
Date of first response to first documented disease progression or date of death from any cause, whichever came first, assessed up to 24 months post treatment4
Median Duration of Complete Response
The time subjects achieve complete response to disease progression or death and will be estimated using Kaplan Meier method or cumulative incidence curves.
Time frame
Date of complete response to first documented disease progression or date of death from any cause, whichever came first, assessed up to 24 months post treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
Genmab
Collaborator
Source ClinicalTrials.gov