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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04663347
Registration number
NCT04663347
Ethics application status
Date submitted
27/10/2020
Date registered
11/12/2020
Titles & IDs
Public title
Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)
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Scientific title
A Phase 1b/2, Open-Label Trial to Assess the Safety and Preliminary Efficacy of Epcoritamab (GEN3013; DuoBody®-CD3xCD20) in Combination With Other Agents in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)
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Secondary ID [1]
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2020-000845-15
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Secondary ID [2]
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GCT3013-02
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Universal Trial Number (UTN)
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Trial acronym
EPCORE™ NHL-2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diffuse Large B-Cell Lymphoma
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0
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Follicular Lymphoma
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Condition category
Condition code
Cancer
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0
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0
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
0
0
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0
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone
Treatment: Drugs - rituximab and lenalidomide
Treatment: Drugs - rituximab and bendamustine
Treatment: Drugs - rituximab, cytarabine, dexamethasone, and oxaliplatin/carboplatin
Treatment: Drugs - gemcitabine and oxaliplatin
Treatment: Other - Epcoritamab
Treatment: Drugs - rituximab, cyclophosphamide, reduced dose of doxorubicin, vincristine, and prednisone
Treatment: Drugs - Lenalidomide
Treatment: Drugs - rituximab, ifosfamide, carboplatin, and etoposide phosphate
Treatment: Other - Epcoritamab
Treatment: Other - Epcoritamab
Treatment: Other - Epcoritamab
Treatment: Other - Epcoritamab
Treatment: Other - Epcoritamab
Treatment: Other - Epcoritamab
Treatment: Other - Epcoritamab
Experimental: Arm 1 - Epcoritamab + R-CHOP - In participants with previously untreated DLBCL.
Experimental: Arm 2 - Epcoritamab + R2 - In participants with R/R FL.
Experimental: Arm 3 - Epcoritamab + BR - In participants with previously untreated FL.
Experimental: Arm 4 - Epcoritamab + R-DHAX/C - In participants with R/R DLBCL eligible for ASCT.
Experimental: Arm 5 - Epcoritamab + GemOx - In participants with R/R DLBCL ineligible ASCT.
Experimental: Arm 6 - Epcoritamab + R2 - In participants with previously untreated FL.
Experimental: Arm 7 - Epcoritamab maintenance - In participants with FL who achieved a CR or PR after receiving SOC treatment in 1L or 2L.
Experimental: Arm 8 - Epcoritamab + R mini-CHOP - In participants with previously untreated DLBCL who are ineligible to receive full-dose anthracycline.
Experimental: Arm 9 - Epcoritamab + Lenalidomide - In participants with R/R FL who progressed within 24 months of initiation of first-line anti-CD20-containing immunochemotherapy.
Experimental: Arm 10 - Epcoritamab + R-ICE - In participants with R/R DLBCL eligible for ASCT.
Treatment: Drugs: rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone
21-day cycles
Treatment: Drugs: rituximab and lenalidomide
28-day cycles
Treatment: Drugs: rituximab and bendamustine
28-day cycles
Treatment: Drugs: rituximab, cytarabine, dexamethasone, and oxaliplatin/carboplatin
21-day cycles
Treatment: Drugs: gemcitabine and oxaliplatin
28-day cycles
Treatment: Other: Epcoritamab
Every week in cycle 1-4, every 3 weeks in cycle 5 and 6, followed by every 4 weeks in cycle 7 for a total of 1 year.
Treatment: Drugs: rituximab, cyclophosphamide, reduced dose of doxorubicin, vincristine, and prednisone
21-day cycles
Treatment: Drugs: Lenalidomide
28-day cycles
Treatment: Drugs: rituximab, ifosfamide, carboplatin, and etoposide phosphate
21-day cycles
Treatment: Other: Epcoritamab
Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years.
Treatment: Other: Epcoritamab
Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until disease progression or unacceptable toxicity.
Treatment: Other: Epcoritamab
Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.
Treatment: Other: Epcoritamab
Every week in cycle 1 and then every 8 weeks for a total of 2 years.
Treatment: Other: Epcoritamab
Every week in cycles 1 and 2, then every 3 weeks in cycles 3 to 6 and then every 4 weeks for cycles 7 and 8.
Treatment: Other: Epcoritamab
Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.
Treatment: Other: Epcoritamab
Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until transplant or disease progression.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Other
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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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Part 1: Number of Participants With Dose limiting Toxicities (DLTs)
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Assessment method [1]
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DLT events are 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 (Cycle length= 28 days) in each cohort
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Primary outcome [2]
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Part 1 and Part 2 (Arm 7): Number of Participants With Adverse Events (AEs)
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Assessment method [2]
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An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign. (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
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Timepoint [2]
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From first dose of trial medication to the maximum of 60 days after last dose of epcoritamab or initiation of subsequent anti-lymphoma therapy.
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Primary outcome [3]
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Part 2 (Except Arm 7): Overall Response Rate (ORR)
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Assessment method [3]
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ORR is defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on Lugano criteria.
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Timepoint [3]
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Up to 3 years
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Secondary outcome [1]
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Part 1 and 2: Clearance (CL) of Epcoritamab
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Assessment method [1]
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Timepoint [1]
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Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years)
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Secondary outcome [2]
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Part 1 and 2: Volume of Distribution (Vd) of Epcoritamab
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Assessment method [2]
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Timepoint [2]
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Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years)
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Secondary outcome [3]
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Part 1 and 2: Area Under the Concentration-Time Curve (AUC) from Time Zero to Last Quantifiable Dose (AUC0-last) of Epcoritamab
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Assessment method [3]
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0
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Timepoint [3]
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Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years)
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Secondary outcome [4]
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Part 1 and 2: Area Under the Concentration-Time Curve (AUC) from Time Zero to Infinity (AUC0-inf) of Epcoritamab
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Assessment method [4]
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0
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Timepoint [4]
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Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years)
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Secondary outcome [5]
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Part 1 and 2: Maximum (Peak) Plasma Concentration (Cmax) of Epcoritamab
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Assessment method [5]
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0
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Timepoint [5]
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Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years)
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Secondary outcome [6]
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Part 1 and 2: Time to Reach Cmax (Tmax) of Epcoritamab
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Assessment method [6]
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0
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Timepoint [6]
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Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years)
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Secondary outcome [7]
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Part 1 and 2: Terminal Elimination Half-Life (t 1/2) of Epcoritamab
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Assessment method [7]
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Timepoint [7]
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Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years)
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Secondary outcome [8]
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Part 1 and 2: Plasma Trough (Pre-dose) Concentrations (Ctrough) of Epcoritamab
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Assessment method [8]
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Timepoint [8]
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Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years)
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Secondary outcome [9]
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Part 1 and 2: Number of Immune Cell Populations
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Assessment method [9]
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Immune cell populations in peripheral blood and tumor biopsies will be assessed.
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Timepoint [9]
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Up to 2 years
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Secondary outcome [10]
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Part 1 and 2: Percentage of Immune Cell Populations
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Assessment method [10]
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Immune cell populations in peripheral blood and tumor biopsies will be assessed.
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Timepoint [10]
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Up to 2 years
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Secondary outcome [11]
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Part 1 and 2: Change From Baseline in Cytokine Levels up to Cycle 3
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Assessment method [11]
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Change in cytokine levels in peripheral blood samples will be assessed.
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Timepoint [11]
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0
Up to Cycle 3 (cycle length = 21 days for Arms 1, 4, 8 and 10; cycle length = 28 days for Arms 2, 3, 5, 6 and 9; cycle length = 28 days (Cycle 1) and 56 days (Cycles 2, 3) for Arm 7)
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Secondary outcome [12]
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Part 1 and 2: Change From Baseline in Circulating Tumor Deoxyribonucleic Acid (DNA) Level up to End of Treatment (up to 2 Years)
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Assessment method [12]
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0
Change in circulating tumor DNA levels will be assessed.
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Timepoint [12]
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Up to 2 years
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Secondary outcome [13]
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Part 1 and 2: Number of Participants With Anti-Drug Antibodies (ADAs) to Epcoritamab
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Assessment method [13]
0
0
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Timepoint [13]
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Up to 3 years
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Secondary outcome [14]
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Part 1: ORR
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Assessment method [14]
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ORR is defined as the percentage of participants achieving CR or PR based on Lugano criteria.
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Timepoint [14]
0
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Up to 3 years
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Secondary outcome [15]
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Part 1 and 2: Duration of Response (DOR)
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Assessment method [15]
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DOR: the time from the first documentation of objective tumor response (CR or PR) to the date of first PD or death based on Lugano criteria.
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Timepoint [15]
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0
Up to 3 years
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Secondary outcome [16]
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Part 1 and 2: Time to Response (TTR)
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Assessment method [16]
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TTR is defined as the time from Day 1 of Cycle 1 to first documentation of objective tumor response (CR or PR).
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Timepoint [16]
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Up to 3 years
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Secondary outcome [17]
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Part 1 and 2: Progression Free Survival (PFS)
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Assessment method [17]
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PFS is defined as the time from Day 1 of Cycle 1 to first documented PD or death due to any cause based on Lugano criteria.
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Timepoint [17]
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Up to 3 years
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Secondary outcome [18]
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Part 1 and 2: Overall Survival (OS)
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Assessment method [18]
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OS is defined as the time from the date of first dose, to the date of death due to any cause.
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Timepoint [18]
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Up to 3 years
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Secondary outcome [19]
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Part 1 and 2: Time to Next Anti-lymphoma Therapy (TTNT)
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Assessment method [19]
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TTNT is defined as the time from Day 1 of Cycle 1 to first documented administration of subsequent anti-lymphoma therapy.
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Timepoint [19]
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Up to 3 years
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Secondary outcome [20]
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Part 1 and 2: Percentage of Participants With Minimal Residual Disease (MRD) Negativity
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Assessment method [20]
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It is defined as the percentage of participants with at least 1 MRD negative result.
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Timepoint [20]
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Up to 3 years
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Secondary outcome [21]
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Part 1 and 2: Duration of minimal residual disease (MRD) negativity
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Assessment method [21]
0
0
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Timepoint [21]
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Up to 3 years
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Secondary outcome [22]
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Part 2 (Arm 7): Percentage of Participants Who Converted From MRD Positivity to MRD Negativity
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Assessment method [22]
0
0
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Timepoint [22]
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Up to 3 years
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Secondary outcome [23]
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0
Part 2 (Except Arm 7): Percentage of Participants with Complete Response (CR) in Arms 1 to 10
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Assessment method [23]
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0
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Timepoint [23]
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Up to 3 years
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Secondary outcome [24]
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Part 2 (Arm 7): Percentage of Participants With CR
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Assessment method [24]
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It is defined as the percentage of participants who remain in complete remission or converting to complete remission after first trial drug administration.
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Timepoint [24]
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Week 24, Week 48, and Week 96
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Secondary outcome [25]
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Part 1 and 2: Time to Complete Response (TTCR)
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Assessment method [25]
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TTCR is defined as the time from first trial drug administration to the date of first documented complete response post-treatment.
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Timepoint [25]
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Up to 3 years
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Secondary outcome [26]
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Part 1 and 2: Duration of Complete Response (DoCR)
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Assessment method [26]
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DoCR is defined as the time from the first documentation of CR to the date of PD or death, whichever occurs first based on Lugano criteria.
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Timepoint [26]
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Up to 3 years
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Eligibility
Key inclusion criteria
Key Inclusion Criteria
1. Measurable disease defined as =1 measurable nodal lesion (long axis >1.5 cm and short axis >1.0 cm) or =1 measurable extra-nodal lesion (long axis >1.0 cm) on computed tomography (CT) or magnetic resonance imaging (MRI)
2. Eastern Cooperative Oncology Group (ECOG) PS score of 0, 1 or 2
3. Acceptable organ function at screening
4. CD20-positive non-Hodgkin lymphoma (NHL) at most recent representative tumor biopsy
5. If of childbearing potential subject must practicing a highly effective method of birth control
6. A man who is sexually active with a woman of childbearing potential must agree to use a barrier method of birth control
Arm 1:
* Newly diagnosed DLBCL
* DLBCL, not otherwise specified (NOS)
* "Double-hit" or "triple-hit" DLBCL
* FL Grade 3B
Arm 2: R/R FL
Arm 3: Newly diagnosed, previously untreated FL grade 1-3A
Arm 4:
* Documented R/R DLBCL and eligible for HDT-ASCT
* DLBCL, NOS
* "Double-hit" or "triple-hit" DLBCL
* FL Grade 3B
Arm 5:
* Documented R/R DLBCL and ineligible for HDT-ASCT
* DLBCL, NOS
* "Double-hit" or "triple-hit" DLBCL
* FL Grade 3B
Arm 6: Newly diagnosed, previously untreated FL grade 1-3A
Arm 7:
* FL Grade 1-3A
* If PR or CR per Lugano criteria following first-line or second-line treatment with SOC regimen, and last dose of SOC within 6 months prior to enrollment.
Arm 8:
* Newly diagnosed DLBCL who are not fit to receive full-dose anthracycline
* T-cell/histiocyte rich DLBCL
* "Double-hit" or "triple-hit" DLBCL
* FL Grade 3B
Arm 9:
* R/R FL
* Progressed within 24 months of initiating first-line treatment
Arm 10:
* Documented R/R DLBCL and eligible for HDT-ASCT
* DLBCL, NOS
* "Double-hit" or "triple-hit" DLBCL
* FL Grade 3B
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. Chemotherapy, radiation therapy, or major surgery within 4 weeks prior to the first dose of epcoritamab
2. Any prior treatment with a bispecific antibody targeting CD3 and CD20.
3. Treatment with CAR-T therapy within 100 days prior to first dose of epcoritamab
4. Clinically significant cardiovascular disease
5. Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
6. CNS lymphoma or known CNS involvement by lymphoma at screening as confirmed by MRI/CT scan of the brain and, if clinically indicated, by lumbar puncture
7. Positive tests for hepatitis B virus or hepatitis C virus indicating acute or chronic infection
8. Known history of seropositivity of human immunodeficiency virus (HIV)
9. Active tuberculosis or history of completed treatment for active tuberculosis within the past 12 months
10. Neuropathy > grade 1
11. Receiving immunostimulatory agent
12. Prior allogeneic HSCT
13. Current seizure disorder requiring anti-epileptic therapy
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
3/11/2020
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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
31/03/2029
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Actual
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Sample size
Target
662
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Monash Medical Centre - Clayton
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Recruitment hospital [2]
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Austin Health - Heidelberg
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Recruitment hospital [3]
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Linear Clinical Research Limited - Nedlands
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Recruitment postcode(s) [1]
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3084 - Clayton
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Recruitment postcode(s) [2]
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VIC 3084 - Heidelberg
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Recruitment postcode(s) [3]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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0
United States of America
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Alabama
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United States of America
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California
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United States of America
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Massachusetts
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United States of America
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Michigan
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United States of America
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New Jersey
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Pennsylvania
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0
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United States of America
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Texas
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Belgium
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Brugge
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Belgium
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Gent
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Belgium
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Yvoir
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Czechia
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Hradec Králové
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0
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Czechia
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State/province [14]
0
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Ostrava - Poruba
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0
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Czechia
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State/province [15]
0
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Prague
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Czechia
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Praha 2
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Denmark
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Arhus
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Denmark
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Copenhagen
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Denmark
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Odense
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Denmark
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Vejle
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Finland
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Helsinki
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Finland
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Kuopio
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Finland
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Lahti
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France
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Bordeaux
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France
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Dijon
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France
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Lille
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France
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Marseille
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France
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Paris
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France
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Pierre-Bénite
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Italy
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Bergamo
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Italy
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Bologna
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0
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Italy
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Candiolo
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0
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Italy
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Meldola
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0
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Italy
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Milan
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0
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Italy
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Pavia
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0
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Italy
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Reggio Emilia
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0
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Netherlands
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Amsterdam
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Netherlands
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Groningen
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Netherlands
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Leiden
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Netherlands
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Maastricht
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Netherlands
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Rotterdam
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Netherlands
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Utrecht
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Norway
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Oslo
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Spain
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Barcelona
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Spain
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Madrid
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Country [46]
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Spain
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Salamanca
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Country [47]
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Sweden
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State/province [47]
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Borås
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Country [48]
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Sweden
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Göteborg
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Sweden
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Lund
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Sweden
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Solna
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Sweden
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Umeå
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Sweden
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Uppsala
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Country [53]
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0
United Kingdom
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State/province [53]
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London
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Country [54]
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0
United Kingdom
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Manchester
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Country [55]
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0
United Kingdom
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Newcastle Upon Tyne
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Country [56]
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0
United Kingdom
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State/province [56]
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0
Plymouth
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Genmab
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Address
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Other collaborator category [1]
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0
Commercial sector/industry
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Name [1]
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AbbVie
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Address [1]
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0
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0
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this trial is to measure the safety and effectiveness of epcoritamab (EPKINLY™), either by itself or together with other therapies, when treating subjects with B-cell non-Hodgkin Lymphoma (B-NHL). The aim of the first part of the trial is to identify the most appropriate dose of epcoritamab, and the aim of the second part of the trial is to assess the selected epcoritamab dose in a larger group of participants with B-NHL. All participants in this trial will receive either epcoritamab alone, or epcoritamab combined with another standard treatment regimen, with a total of 10 different treatment arms being studied. Trial details include: * The total trial duration will be up to 6 years. * The treatment duration for each participant depends upon which arm of treatment they are assigned to receive, but will be no more than 3 years. * The visit frequency for each participant depends upon which arm of treatment they are assigned to receive, but will be weekly to start for all participants, then will decrease to either: every 2 weeks, or every 3 weeks, or every 4 weeks, or every 8 weeks. * All participants will receive active drug; no one will be given placebo. Participants who receive treatment with epcoritamab will have it injected right under the skin. Participants will receive a different regimen of epcoritamab depending upon which arm of treatment they are assigned. Participants who receive standard treatments will have IV infusions and/or oral administration of those treatments. Participants will receive a different standard treatment regimen depending upon which arm of treatment they are assigned. Arm 9 (follicular lymphoma (FL)) is still open for enrolment of new patients, while the other arms have closed their recruitment.
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Trial website
https://clinicaltrials.gov/study/NCT04663347
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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 A/S Trial Information
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Address
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Phone
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+45 70202728
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Fax
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Email
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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/NCT04663347