Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04663347
Registration number
NCT04663347
Ethics application status
Date submitted
27/10/2020
Date registered
11/12/2020
Date last updated
31/05/2024
Titles & IDs
Public title
Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)
Query!
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)
Query!
Secondary ID [1]
0
0
2020-000845-15
Query!
Secondary ID [2]
0
0
GCT3013-02
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
EPCORE™ NHL-2
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Diffuse Large B-Cell Lymphoma
0
0
Query!
Follicular Lymphoma
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Query!
Cancer
0
0
0
0
Query!
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Query!
Intervention/exposure
Study type
Interventional(has expanded access)
Query!
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
Other interventions - Epcoritamab
Treatment: Drugs - rituximab, cyclophosphamide, reduced dose of doxorubicin, vincristine, and prednisone
Treatment: Drugs - Lenalidomide
Treatment: Drugs - rituximab, ifosfamide, carboplatin, and etoposide phosphate
Other interventions - Epcoritamab
Other interventions - Epcoritamab
Other interventions - Epcoritamab
Other interventions - Epcoritamab
Other interventions - Epcoritamab
Other interventions - Epcoritamab
Other interventions - 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
Other interventions: 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
Other interventions: 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.
Other interventions: 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.
Other interventions: Epcoritamab
Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.
Other interventions: Epcoritamab
Every week in cycle 1 and then every 8 weeks for a total of 2 years.
Other interventions: 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.
Other interventions: Epcoritamab
Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.
Other interventions: Epcoritamab
Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until transplant or disease progression.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Intervention code [2]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Part 1: Number of Participants With Dose limiting Toxicities (DLTs)
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
During the first cycle (Cycle length= 28 days) in each cohort
Query!
Primary outcome [2]
0
0
Part 1 and Part 2 (Arm 7): Number of Participants With Adverse Events (AEs)
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
From first dose of trial medication to the maximum of 60 days after last dose of epcoritamab or initiation of subsequent anti-lymphoma therapy.
Query!
Primary outcome [3]
0
0
Part 2 (Except Arm 7): Overall Response Rate (ORR)
Query!
Assessment method [3]
0
0
ORR is defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on Lugano criteria.
Query!
Timepoint [3]
0
0
Up to 3 years
Query!
Secondary outcome [1]
0
0
Part 1 and 2: Clearance (CL) of Epcoritamab
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years)
Query!
Secondary outcome [2]
0
0
Part 1 and 2: Volume of Distribution (Vd) of Epcoritamab
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years)
Query!
Secondary outcome [3]
0
0
Part 1 and 2: Area Under the Concentration-Time Curve (AUC) from Time Zero to Last Quantifiable Dose (AUC0-last) of Epcoritamab
Query!
Assessment method [3]
0
0
Query!
Timepoint [3]
0
0
Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years)
Query!
Secondary outcome [4]
0
0
Part 1 and 2: Area Under the Concentration-Time Curve (AUC) from Time Zero to Infinity (AUC0-inf) of Epcoritamab
Query!
Assessment method [4]
0
0
Query!
Timepoint [4]
0
0
Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years)
Query!
Secondary outcome [5]
0
0
Part 1 and 2: Maximum (Peak) Plasma Concentration (Cmax) of Epcoritamab
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years)
Query!
Secondary outcome [6]
0
0
Part 1 and 2: Time to Reach Cmax (Tmax) of Epcoritamab
Query!
Assessment method [6]
0
0
Query!
Timepoint [6]
0
0
Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years)
Query!
Secondary outcome [7]
0
0
Part 1 and 2: Terminal Elimination Half-Life (t 1/2) of Epcoritamab
Query!
Assessment method [7]
0
0
Query!
Timepoint [7]
0
0
Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years)
Query!
Secondary outcome [8]
0
0
Part 1 and 2: Plasma Trough (Pre-dose) Concentrations (Ctrough) of Epcoritamab
Query!
Assessment method [8]
0
0
Query!
Timepoint [8]
0
0
Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years)
Query!
Secondary outcome [9]
0
0
Part 1 and 2: Number of Immune Cell Populations
Query!
Assessment method [9]
0
0
Immune cell populations in peripheral blood and tumor biopsies will be assessed.
Query!
Timepoint [9]
0
0
Up to 2 years
Query!
Secondary outcome [10]
0
0
Part 1 and 2: Percentage of Immune Cell Populations
Query!
Assessment method [10]
0
0
Immune cell populations in peripheral blood and tumor biopsies will be assessed.
Query!
Timepoint [10]
0
0
Up to 2 years
Query!
Secondary outcome [11]
0
0
Part 1 and 2: Change From Baseline in Cytokine Levels up to Cycle 3
Query!
Assessment method [11]
0
0
Change in cytokine levels in peripheral blood samples will be assessed.
Query!
Timepoint [11]
0
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)
Query!
Secondary outcome [12]
0
0
Part 1 and 2: Change From Baseline in Circulating Tumor Deoxyribonucleic Acid (DNA) Level up to End of Treatment (up to 2 Years)
Query!
Assessment method [12]
0
0
Change in circulating tumor DNA levels will be assessed.
Query!
Timepoint [12]
0
0
Up to 2 years
Query!
Secondary outcome [13]
0
0
Part 1 and 2: Number of Participants With Anti-Drug Antibodies (ADAs) to Epcoritamab
Query!
Assessment method [13]
0
0
Query!
Timepoint [13]
0
0
Up to 3 years
Query!
Secondary outcome [14]
0
0
Part 1: ORR
Query!
Assessment method [14]
0
0
ORR is defined as the percentage of participants achieving CR or PR based on Lugano criteria.
Query!
Timepoint [14]
0
0
Up to 3 years
Query!
Secondary outcome [15]
0
0
Part 1 and 2: Duration of Response (DOR)
Query!
Assessment method [15]
0
0
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.
Query!
Timepoint [15]
0
0
Up to 3 years
Query!
Secondary outcome [16]
0
0
Part 1 and 2: Time to Response (TTR)
Query!
Assessment method [16]
0
0
TTR is defined as the time from Day 1 of Cycle 1 to first documentation of objective tumor response (CR or PR).
Query!
Timepoint [16]
0
0
Up to 3 years
Query!
Secondary outcome [17]
0
0
Part 1 and 2: Progression Free Survival (PFS)
Query!
Assessment method [17]
0
0
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.
Query!
Timepoint [17]
0
0
Up to 3 years
Query!
Secondary outcome [18]
0
0
Part 1 and 2: Overall Survival (OS)
Query!
Assessment method [18]
0
0
OS is defined as the time from the date of first dose, to the date of death due to any cause.
Query!
Timepoint [18]
0
0
Up to 3 years
Query!
Secondary outcome [19]
0
0
Part 1 and 2: Time to Next Anti-lymphoma Therapy (TTNT)
Query!
Assessment method [19]
0
0
TTNT is defined as the time from Day 1 of Cycle 1 to first documented administration of subsequent anti-lymphoma therapy.
Query!
Timepoint [19]
0
0
Up to 3 years
Query!
Secondary outcome [20]
0
0
Part 1 and 2: Percentage of Participants With Minimal Residual Disease (MRD) Negativity
Query!
Assessment method [20]
0
0
It is defined as the percentage of participants with at least 1 MRD negative result.
Query!
Timepoint [20]
0
0
Up to 3 years
Query!
Secondary outcome [21]
0
0
Part 1 and 2: Duration of minimal residual disease (MRD) negativity
Query!
Assessment method [21]
0
0
Query!
Timepoint [21]
0
0
Up to 3 years
Query!
Secondary outcome [22]
0
0
Part 2 (Arm 7): Percentage of Participants Who Converted From MRD Positivity to MRD Negativity
Query!
Assessment method [22]
0
0
Query!
Timepoint [22]
0
0
Up to 3 years
Query!
Secondary outcome [23]
0
0
Part 2 (Except Arm 7): Percentage of Participants with Complete Response (CR) in Arms 1 to 10
Query!
Assessment method [23]
0
0
Query!
Timepoint [23]
0
0
Up to 3 years
Query!
Secondary outcome [24]
0
0
Part 2 (Arm 7): Percentage of Participants With CR
Query!
Assessment method [24]
0
0
It is defined as the percentage of participants who remain in complete remission or converting to complete remission after first trial drug administration.
Query!
Timepoint [24]
0
0
Week 24, Week 48, and Week 96
Query!
Secondary outcome [25]
0
0
Part 1 and 2: Time to Complete Response (TTCR)
Query!
Assessment method [25]
0
0
TTCR is defined as the time from first trial drug administration to the date of first documented complete response post-treatment.
Query!
Timepoint [25]
0
0
Up to 3 years
Query!
Secondary outcome [26]
0
0
Part 1 and 2: Duration of Complete Response (DoCR)
Query!
Assessment method [26]
0
0
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.
Query!
Timepoint [26]
0
0
Up to 3 years
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 1/Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
3/11/2020
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
31/03/2029
Query!
Actual
Query!
Sample size
Target
662
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
0
0
Monash Medical Centre - Clayton
Query!
Recruitment hospital [2]
0
0
Austin Health - Heidelberg
Query!
Recruitment hospital [3]
0
0
Linear Clinical Research Limited - Nedlands
Query!
Recruitment postcode(s) [1]
0
0
3084 - Clayton
Query!
Recruitment postcode(s) [2]
0
0
VIC 3084 - Heidelberg
Query!
Recruitment postcode(s) [3]
0
0
6009 - Nedlands
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Massachusetts
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Michigan
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
New Jersey
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
New York
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
North Carolina
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Pennsylvania
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Texas
Query!
Country [10]
0
0
Belgium
Query!
State/province [10]
0
0
Brugge
Query!
Country [11]
0
0
Belgium
Query!
State/province [11]
0
0
Gent
Query!
Country [12]
0
0
Belgium
Query!
State/province [12]
0
0
Yvoir
Query!
Country [13]
0
0
Czechia
Query!
State/province [13]
0
0
Hradec Králové
Query!
Country [14]
0
0
Czechia
Query!
State/province [14]
0
0
Ostrava - Poruba
Query!
Country [15]
0
0
Czechia
Query!
State/province [15]
0
0
Prague
Query!
Country [16]
0
0
Czechia
Query!
State/province [16]
0
0
Praha 2
Query!
Country [17]
0
0
Denmark
Query!
State/province [17]
0
0
Arhus
Query!
Country [18]
0
0
Denmark
Query!
State/province [18]
0
0
Copenhagen
Query!
Country [19]
0
0
Denmark
Query!
State/province [19]
0
0
Odense
Query!
Country [20]
0
0
Denmark
Query!
State/province [20]
0
0
Vejle
Query!
Country [21]
0
0
Finland
Query!
State/province [21]
0
0
Helsinki
Query!
Country [22]
0
0
Finland
Query!
State/province [22]
0
0
Kuopio
Query!
Country [23]
0
0
Finland
Query!
State/province [23]
0
0
Lahti
Query!
Country [24]
0
0
France
Query!
State/province [24]
0
0
Bordeaux
Query!
Country [25]
0
0
France
Query!
State/province [25]
0
0
Dijon
Query!
Country [26]
0
0
France
Query!
State/province [26]
0
0
Lille
Query!
Country [27]
0
0
France
Query!
State/province [27]
0
0
Marseille
Query!
Country [28]
0
0
France
Query!
State/province [28]
0
0
Paris
Query!
Country [29]
0
0
France
Query!
State/province [29]
0
0
Pierre-Bénite
Query!
Country [30]
0
0
Italy
Query!
State/province [30]
0
0
Bergamo
Query!
Country [31]
0
0
Italy
Query!
State/province [31]
0
0
Bologna
Query!
Country [32]
0
0
Italy
Query!
State/province [32]
0
0
Candiolo
Query!
Country [33]
0
0
Italy
Query!
State/province [33]
0
0
Meldola
Query!
Country [34]
0
0
Italy
Query!
State/province [34]
0
0
Milan
Query!
Country [35]
0
0
Italy
Query!
State/province [35]
0
0
Pavia
Query!
Country [36]
0
0
Italy
Query!
State/province [36]
0
0
Reggio Emilia
Query!
Country [37]
0
0
Netherlands
Query!
State/province [37]
0
0
Amsterdam
Query!
Country [38]
0
0
Netherlands
Query!
State/province [38]
0
0
Groningen
Query!
Country [39]
0
0
Netherlands
Query!
State/province [39]
0
0
Leiden
Query!
Country [40]
0
0
Netherlands
Query!
State/province [40]
0
0
Maastricht
Query!
Country [41]
0
0
Netherlands
Query!
State/province [41]
0
0
Rotterdam
Query!
Country [42]
0
0
Netherlands
Query!
State/province [42]
0
0
Utrecht
Query!
Country [43]
0
0
Norway
Query!
State/province [43]
0
0
Oslo
Query!
Country [44]
0
0
Spain
Query!
State/province [44]
0
0
Barcelona
Query!
Country [45]
0
0
Spain
Query!
State/province [45]
0
0
Madrid
Query!
Country [46]
0
0
Spain
Query!
State/province [46]
0
0
Salamanca
Query!
Country [47]
0
0
Sweden
Query!
State/province [47]
0
0
Borås
Query!
Country [48]
0
0
Sweden
Query!
State/province [48]
0
0
Göteborg
Query!
Country [49]
0
0
Sweden
Query!
State/province [49]
0
0
Lund
Query!
Country [50]
0
0
Sweden
Query!
State/province [50]
0
0
Solna
Query!
Country [51]
0
0
Sweden
Query!
State/province [51]
0
0
Umeå
Query!
Country [52]
0
0
Sweden
Query!
State/province [52]
0
0
Uppsala
Query!
Country [53]
0
0
United Kingdom
Query!
State/province [53]
0
0
London
Query!
Country [54]
0
0
United Kingdom
Query!
State/province [54]
0
0
Manchester
Query!
Country [55]
0
0
United Kingdom
Query!
State/province [55]
0
0
Newcastle Upon Tyne
Query!
Country [56]
0
0
United Kingdom
Query!
State/province [56]
0
0
Plymouth
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Genmab
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/Industry
Query!
Name [1]
0
0
AbbVie
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT04663347
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Genmab A/S Trial Information
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
+45 70202728
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04663347
Download to PDF