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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04623541
Registration number
NCT04623541
Ethics application status
Date submitted
27/10/2020
Date registered
10/11/2020
Titles & IDs
Public title
Safety and Efficacy Study of Epcoritamab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome
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Scientific title
A Phase 1b/2, Open-Label, Safety and Efficacy Study of Epcoritamab (GEN3013; DuoBody®-CD3xCD20) in Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome
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Secondary ID [1]
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2020-000848-57
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Secondary ID [2]
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GCT3013-03
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Universal Trial Number (UTN)
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Trial acronym
EPCORE™ CLL-1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Relapsed/Refractory Chronic Lymphocytic Leukemia
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Small Lymphocytic Lymphoma
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Richter's Syndrome
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Other - Epcoritamab
Treatment: Other - Epcoritamab
Treatment: Drugs - rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone
Treatment: Drugs - Venetoclax
Treatment: Other - Epcoritamab
Treatment: Drugs - Lenalidomide
Experimental: Epcoritamab in R/R CLL/SLL - In both study phases. Participants in the expansion phase will be treated at the RP2D defined in the dose-escalation phase.
Experimental: Epcoritamab in RS - Only in expansion phase.
Experimental: Epcoritamab + Venetoclax in R/R CLL/SLL - In both study phases. Participants in the expansion phase will be treated at the RP2D defined in the dose-escalation phase.
Experimental: Epcoritamab + Lenalidomide in RS - Only in expansion phase.
Experimental: Epcoritamab + R-CHOP in RS - Only in expansion phase.
Treatment: Other: Epcoritamab
Epcoritamab will be administered subcutaneously in cycles of 28 days (except Cycle 1 for high-dose cohorts = 35 days).
Treatment: Other: Epcoritamab
Epcoritamab will be administered subcutaneously in cycles of 21 days (Cycle 1-6) and 28 days for Cycle 7 and beyond.
Treatment: Drugs: rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone
R-CHOP will be administered intravenously in cycles of 21 days for the first 6 cycles.
Treatment: Drugs: Venetoclax
Venetoclax tablets will be administered orally once daily during the 5-week ramp up period and during Cycle 1-26 of 28 or 35 days each.
Treatment: Other: Epcoritamab
Epcoritamab will be administered subcutaneously in cycles of 28 days.
Treatment: Drugs: Lenalidomide
Lenalidomide capsules will be administered once daily for 21 days in each cycle of 28 days up to 12 cycles.
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Dose Escalation Phase (R/R CLL arm): Number of Participants with Dose Limiting Toxicities (DLTs)
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Assessment method [1]
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DLT events were defined as clinically significant adverse events (AEs) or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications as assessed per Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria version 5.0.
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Timepoint [1]
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During the first cycle for low dose cohorts (Cycle length = 28 days) and for high dose cohorts (Cycle length = 35 days)
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Primary outcome [2]
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Dose Escalation Phase: Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
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Assessment method [2]
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Timepoint [2]
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From first dose until the end of the safety follow-up period (60 days after last dose)
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Primary outcome [3]
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Dose Escalation Phase: Number of Participants with Cytokine Release Syndrome (CRS), Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and Clinical Tumor Lysis Syndrome (CTLS)
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Assessment method [3]
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CRS and ICANS will be graded based on American Society for Transplantation and Cellular Therapy (ASTCT) criteria. CTLS will be graded according to Cairo-Bishop criteria.
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Timepoint [3]
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From first dose until the end of the safety follow-up period (60 days after last dose)
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Primary outcome [4]
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Expansion Phase: Overall Response Rate (ORR)
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Assessment method [4]
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ORR is defined as the percentage of participants who achieve a response of partial response or complete response, prior to initiation of subsequent therapy. R/R CLL participants will be assessed according to International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria and the RS participants according to Lugano criteria.
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Timepoint [4]
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Up to 5 years
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Secondary outcome [1]
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Expansion Phase: Number of Participants with TEAEs and SAEs
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Assessment method [1]
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Timepoint [1]
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From first dose until the end of the safety follow-up period (60 days after last dose)
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Secondary outcome [2]
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Dose Escalation Phase: ORR
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Assessment method [2]
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ORR is defined as percentage of participants who achieve a response of partial response or complete response, prior to initiation of subsequent therapy as assessed by iwCLL criteria.
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Timepoint [2]
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Up to 5 years
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Secondary outcome [3]
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Both Phases: Duration of Response (DOR)
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Assessment method [3]
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DOR is defined among responders, as the time from the initial documentation of response to the date of disease progression or death, whichever occurs earlier.
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Timepoint [3]
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Up to 5 years
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Secondary outcome [4]
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Both Phases: Number of Participants with Complete Remission (CR) / CR with Incomplete Bone Marrow Recovery (CRi)
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Assessment method [4]
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CR and CRi for R/R CLL participants will be assessed according to iwCLL criteria and CR for the RS participants, according to Lugano criteria.
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Timepoint [4]
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Up to 5 years
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Secondary outcome [5]
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Both Phases: Time to Response (TTR)
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Assessment method [5]
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TTR is defined among responders, as the time between first dose of epcoritamab and the initial documentation of response.
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Timepoint [5]
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Up to 5 years
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Secondary outcome [6]
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Both Phases: Progression Free Survival (PFS)
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Assessment method [6]
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PFS is defined as the time from the first dosing date of epcoritamab and the date of disease progression or death, whichever occurs earlier.
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Timepoint [6]
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Up to 5 years
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Secondary outcome [7]
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Both Phases: Overall Survival (OS)
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Assessment method [7]
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OS is defined as the time from the first dosing date of epcoritamab and the date of death due to any cause.
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Timepoint [7]
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Up to 5 years
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Secondary outcome [8]
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Both Phases: Time to Next Systemic Anti-cancer Therapy (TTNT)
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Assessment method [8]
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TTNT is defined as the time from the first dosing date of epcoritamab to the first documented administration of subsequent systemic anticancer therapy.
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Timepoint [8]
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Up to 5 years
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Secondary outcome [9]
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Both Phases: Area Under the Concentration-time Curve (AUC) From Time Zero to Last Quantifiable Sample (AUClast) in Epcoritamab
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Assessment method [9]
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Timepoint [9]
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Predose and post dose at multiple timepoints at end of each cycle for low dose and high dose cohorts (Cycle length = 28 days, except Cycle 1 for high dose cohorts = 35 Days)
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Secondary outcome [10]
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Both Phases: AUC From Time Zero to Infinity (AUCinf) in Epcoritamab
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Assessment method [10]
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Timepoint [10]
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Predose and post dose at multiple timepoints at end of each cycle for low dose and high dose cohorts (Cycle length = 28 days, except Cycle 1 for high dose cohorts = 35 Days)
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Secondary outcome [11]
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Both Phases: Maximum (Peak) Plasma Concentration (Cmax) in Epcoritamab
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Assessment method [11]
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Timepoint [11]
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Predose and post dose at multiple timepoints at end of each cycle for low dose and high dose cohorts (Cycle length = 28 days, except Cycle 1 for high dose cohorts = 35 Days)
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Secondary outcome [12]
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Both Phases: Pre-dose (Trough) Concentrations (Cthrough) in Epcoritamab
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Assessment method [12]
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Timepoint [12]
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Predose and post dose at multiple timepoints at end of each cycle for low dose and high dose cohorts (Cycle length = 28 days, except Cycle 1 for high dose cohorts = 35 Days)
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Secondary outcome [13]
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Both Phases: Time to Reach Cmax (Tmax) in Epcoritamab
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Assessment method [13]
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Timepoint [13]
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Predose and post dose at multiple timepoints at end of each cycle for low dose and high dose cohorts (Cycle length = 28 days, except Cycle 1 for high dose cohorts = 35 Days)
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Secondary outcome [14]
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Both Phases: Elimination Half-life (T1/2) in Epcoritamab
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Assessment method [14]
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Timepoint [14]
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Predose and post dose at multiple timepoints at end of each cycle for low dose and high dose cohorts (Cycle length = 28 days, except Cycle 1 for high dose cohorts = 35 Days)
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Secondary outcome [15]
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Both Phases: Total Body Clearance of Drug From Plasma (CL) in Epcoritamab
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Assessment method [15]
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Timepoint [15]
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Predose and post dose at multiple timepoints at end of each cycle for low dose and high dose cohorts (Cycle length = 28 days, except Cycle 1 for high dose cohorts = 35 Days)
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Secondary outcome [16]
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Both Phases: Volume of distribution (Vd) in Epcoritamab
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Assessment method [16]
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Timepoint [16]
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Predose and post dose at multiple timepoints at end of each cycle for low dose and high dose cohorts (Cycle length = 28 days, except Cycle 1 for high dose cohorts = 35 Days)
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Secondary outcome [17]
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Both Phases: Lymphoid Cells for Immunophenotyping
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Assessment method [17]
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Evaluation of B cells, T cells and their activation
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Timepoint [17]
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Up to 5 years
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Secondary outcome [18]
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Expansion Phase: Number of Participants with CRS, ICANS and CTLS
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Assessment method [18]
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CRS and ICANS will be graded based on ASTCT criteria. CTLS will be graded according to Cairo-Bishop criteria.
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Timepoint [18]
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From first dose until the end of the safety follow-up period (60 days after last dose)
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Secondary outcome [19]
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Expansion Phase: Percentage of Participants with Minimal Residual Disease (MRD) Negativity
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Assessment method [19]
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MRD negativity rate, is defined as the proportion of participants with at least 1 undetectable MRD result according to the specific threshold, prior to initiation of subsequent therapy.
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Timepoint [19]
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Up to 5 years
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Secondary outcome [20]
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Both Phases: Number of Participants with Anti-drug Antibodies (ADA) to Epcoritamab
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Assessment method [20]
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Timepoint [20]
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Up to end of treatment period (Up to 2 years)
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Secondary outcome [21]
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Expansion Phase: Number of Participants with Partial Remission (PR)/Nodular Partial Remission (nPR)
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Assessment method [21]
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nPR is defined as PR with residual nodules or suspicious lymphocytic infiltrates in participants who are in remission. nPR is only calculated for R/R CLL.
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Timepoint [21]
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Up to 5 years
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Secondary outcome [22]
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Both Phases: Duration of MRD Negativity
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Assessment method [22]
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The time from first achieving MRD negativity after start of treatment to the MRD conversion to positive.
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Timepoint [22]
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Up to 5 years
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Eligibility
Key inclusion criteria
Key Inclusion Criteria
1. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.
2. Evidence of CD20 positivity in a sample representative of the disease at Screening.
3. Acceptable hematology parameters and organ function based on baseline bloodwork.
4. For R/R CLL arms - Must have active CLL/SLL disease requiring treatment per iwCLL 2018 criteria.
5. For R/R CLL arms - Received at least 2 prior lines of systemic anti-neoplastic therapy including a Bruton's tyrosine kinase (BTK) inhibitor.
6. For all RS arms - Have tumor biopsy-proven CD20+ Diffuse large B-cell Lymphoma (DLBCL) and a clinical history of CLL/SLL.
7. For all RS arms - Must have measurable disease by fluorodeoxyglucose-positron emission tomography (FDG-PET) and computed tomography (CT) or magnetic resonance imaging (MRI) scan.
8. For all RS arms - Must provide mandatory formalin-fixed, paraffin-embedded (FFPE) tumor biopsy sample.
9. Life expectancy >3 months on standard of care (SOC).
10. For RS - monotherapy arm: Deemed as ineligible for chemoimmunotherapy at investigator's discretion or participant who refuses to receive intensive chemotherapy
11. For RS - lenalidomide combination therapy arm
* Deemed as ineligible for chemoimmunotherapy at the investigator's discretion, or participant who refuses to receive intensive chemotherapy.
* Eligible for treatment with lenalidomide.
* Must be willing to use contraception and adhere to the Lenalidomide Pregnancy Risk Minimization Plan
12. For RS - R-CHOP combination Therapy Arm -
* Eligible for treatment with R-CHOP.
13. For R/R CLL - venetoclax combination Therapy arm - after receiving at least 1 prior line of systemic antineoplastic therapy.
Key
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion Criteria
1. Received prior treatment with a CD3×CD20 bispecific antibody.
2. Received any prior allogeneic hematopoietic stem cell transplantation (HSCT) or solid organ transplantation.
3. Received (CAR) T-cell therapy within 100 days or an investigational drug within 4 weeks, prior to first dose of epcoritamab.
4. Autoimmune disease or other diseases that require permanent or high-dose immunosuppressive therapy.
5. Received vaccination with live vaccines within 28 days.
6. Clinically significant cardiac disease.
7. Known current malignancy other than inclusion diagnosis.
8. Has had major surgery within 4 weeks.
9. Active hepatitis B virus or active hepatitis C.
10. Known history of HIV.
11. For R/R CLL arms - Any history of RS or evidence indicating a potential Richter's transformation.
12. Received venetoclax within 24 months prior to beginning venetoclax ramp-up for this trial and progressed on treatment.
13. For all RS arms - Diagnosis of Richter's syndrome not of the DLBCL subtype such as Hodgkin's lymphoma, prolymphocytic leukemia.
14. RS - Lenalidomide Combination Therapy and RS Monotherapy Arms - received more than 2 prior lines of therapy for RS.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
25/11/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/08/2029
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Actual
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Sample size
Target
184
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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St. George Hospital - Kogarah
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Recruitment hospital [2]
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Barwon Health - Geelong
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Recruitment hospital [3]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment hospital [4]
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Alfred Health - Melbourne
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Recruitment postcode(s) [1]
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- Kogarah
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Recruitment postcode(s) [2]
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- Geelong
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Recruitment postcode(s) [3]
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3000 - Melbourne
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Recruitment postcode(s) [4]
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3004 - Melbourne
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Recruitment outside Australia
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Alabama
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California
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Florida
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Massachusetts
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Michigan
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New Jersey
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Ohio
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Texas
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Washington
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Belgium
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Bruges
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Gent
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Leuven
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Nové Mesto
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Nový Hradec Králové
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Poruba
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Brno
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Olomouc
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Hovedstaden
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Aalborg
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Odense
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Koeln
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Israel
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Israel
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Petah Tikva
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Israel
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Ramat Gan
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Israel
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Tel Aviv-Yafo
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Italy
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Forli - Cesena
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Novara
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Roma
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South Holland
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Netherlands
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Amsterdam
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Groningen
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Utrecht
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Barcelona
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Ferarra
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Spain
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United Kingdom
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State/province [56]
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Cornwall
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Country [57]
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United Kingdom
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State/province [57]
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Nottinghamshire
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Country [58]
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United Kingdom
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State/province [58]
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West Yorkshire
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Country [59]
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United Kingdom
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State/province [59]
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Genmab
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Commercial sector/industry
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Name [1]
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AbbVie
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Ethics approval
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Summary
Brief summary
The study is a global, multi-center safety and efficacy trial of epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20). Epcoritamab will either be studied as: * Monotherapy, or * Combination therapy: * epcoritamab + venetoclax * epcoritamab + lenalidomide * epcoritamab + R-CHOP (i.e., rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine (Oncovin®) and prednisone). The study includes patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL)/small lymphocytic lymphoma (SLL) and patients with Richter's Syndrome (RS). Study participants with R/R CLL/SLL are treated either with epcoritamab as monotherapy or epcoritamab + venetoclax. Study participants with RS are treated either with epcoritamab as monotherapy or epcoritamab + lenalidomide or epcoritamab + R-CHOP. The trial consists of two parts, a dose-escalation phase (phase Ib) and an expansion phase (phase II). Patients with RS are only included in the expansion phase. Epcoritamab will be injected subcutaneously (under the skin). Standard-of-care and combination treatments (venetoclax, lenalidomide, and R-CHOP) will be given either orally (by mouth) or intravenously (in a vein). Study details include: * Study duration will be up to 5 years. * The treatment duration for each participant will be between 18 months (1.5 years) and 24 months (2 years), depending upon the treatment arm assigned. * The visit frequency will be either weekly, every other week, or monthly, depending upon the part of the study. All participants will receive active drug; no one will be given placebo.
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Trial website
https://clinicaltrials.gov/study/NCT04623541
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Contact person for public queries
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Genmab Trial Information
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+4570202728
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04623541