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Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL) (EPCORE™ NHL-2)

Primary Purpose

Diffuse Large B-Cell Lymphoma, Follicular Lymphoma

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone
rituximab and lenalidomide
rituximab and bendamustine
rituximab, cytarabine, dexamethasone, and oxaliplatin/carboplatin
gemcitabine and oxaliplatin
Epcoritamab
rituximab, cyclophosphamide, reduced dose of doxorubicin, vincristine, and prednisone
Lenalidomide
rituximab, ifosfamide, carboplatin, and etoposide phosphate
Epcoritamab
Epcoritamab
Epcoritamab
Epcoritamab
Epcoritamab
Epcoritamab
Epcoritamab
Sponsored by
Genmab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diffuse Large B-Cell Lymphoma focused on measuring DuoBody®, monoclonal antibodies, anti-CD3, anti-CD20

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria

  1. Subject must sign an Informed Consent Form (ICF)
  2. At least 18 years of age
  3. 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)
  4. Eastern Cooperative Oncology Group (ECOG) PS score of 0, 1 or 2
  5. Acceptable organ function at screening
  6. CD20-positive non-Hodgkin lymphoma (NHL) at most recent representative tumor biopsy
  7. If of childbearing potential subject must practicing a highly effective method of birth control
  8. 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 Documented diffuse large B-cell lymphoma (DLBCL)
  • DLBCL, 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 DLBCL and eligible for HDT-ASCT
  • DLBCL, NOS
  • "double-hit" or "triple-hit" DLBCL
  • FL Grade 3B

Arm 5:

  • Relapsed or refractory documented 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:

  • DLBCL, NOS
  • T-cell/histiocyte rich DLBCL
  • "double-hit" or "triple-hit" DLBCL
  • FL Grade 3B

Key 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 30 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. Active 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.

Sites / Locations

  • University of Alabama at BirminghamRecruiting
  • Cedars-Sinai Medical CenterRecruiting
  • David Geffen School of Medicine at UCLARecruiting
  • University of California San FranciscoRecruiting
  • Dana Farber Cancer InstituteRecruiting
  • University of Michigan Comprehensive Cancer CenterRecruiting
  • John Theurer Cancer Center at Hackensack UMCRecruiting
  • Mount SinaiRecruiting
  • Memorial Sloan Kettering CCRecruiting
  • Levine Cancer CenterRecruiting
  • UMPC Hillman Cancer Center Cancer PavillionRecruiting
  • UT Southwestern Medical CenterRecruiting
  • Monash Medical Centre
  • Austin HealthRecruiting
  • Linear Clinical Research LimitedRecruiting
  • AZ Sint-JanRecruiting
  • Universitair Ziekenhuis GentRecruiting
  • CHU UCL Namur Site GodinneRecruiting
  • Fakultni nemocnice Hradec KraloveRecruiting
  • Fakultni nemocnice OstravaRecruiting
  • Fakultni nemocnice v MotoleRecruiting
  • Vseobecna Fakultni NemocniceRecruiting
  • Århus HospitalRecruiting
  • RigshospitaletRecruiting
  • Odense University HospitalRecruiting
  • Vejle SygehusRecruiting
  • Tampere University HospitalRecruiting
  • Kuopio University HospitalRecruiting
  • HUS Cancer CenterRecruiting
  • Institut BergoniéRecruiting
  • CHU Dijon - Hopital du BocageRecruiting
  • Hopital Claude Huriez - CHRU LilleRecruiting
  • Hôpital de la TimoneRecruiting
  • Hôpital Saint-LouisRecruiting
  • Centre Hospitalier Lyon SudRecruiting
  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)Recruiting
  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCSRecruiting
  • Fondazione del Piemonte per l Oncologia Istituto di Candiolo IRCCSRecruiting
  • Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei TumoriRecruiting
  • Fondazione IRCCS CA' Granda Ospedale Maggiore PoliclinicoRecruiting
  • Fondazione IRCCS Policlinico San MatteoRecruiting
  • Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio EmiliaRecruiting
  • Amsterdam UMC, Locatie VUMCRecruiting
  • Universitair Medisch Centrum Groningen (UMCG)Recruiting
  • Leids Universitair Medisch CentrumRecruiting
  • Maastricht University Medical CenterRecruiting
  • Erasmus Medisch CentrumRecruiting
  • UMC UtrechtRecruiting
  • Oslo Universitetssykehus HF, RadiumhospitaletRecruiting
  • ICO l HospitaletRecruiting
  • Hospital Universitari Vall d'HebronRecruiting
  • Hospital Universitario Fundacion Jimenez DiazRecruiting
  • Hospital Universitario La PazRecruiting
  • Hospital Universitario de SalamancaRecruiting
  • Södra Älvsborgs SjukhusRecruiting
  • Sahlgrenska SjukhusetRecruiting
  • Skånes UniversitetssjukhusRecruiting
  • Karolinska UniversitetssjukhusetRecruiting
  • Norrlands UniversitetssjukhusRecruiting
  • Akademiska SjukhusetRecruiting
  • University College London Hospitals
  • The Christie NHS Foundation TrustRecruiting
  • Freeman HospitalRecruiting
  • Derriford HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Arm 1 - Epcoritamab + R-CHOP

Arm 2 - Epcoritamab + R2

Arm 3 - Epcoritamab + BR

Arm 4 - Epcoritamab + R-DHAX/C

Arm 5 - Epcoritamab + GemOx

Arm 6 - Epcoritamab + R2

Arm 7 - Epcoritamab maintenance

Arm 8 - Epcoritamab + R mini-CHOP

Arm 9 - Epcoritamab + Lenalidomide

Arm 10 - Epcoritamab + R-ICE

Arm Description

In participants with previously untreated DLBCL.

In participants with R/R FL.

In participants with previously untreated FL.

In participants with R/R DLBCL eligible for ASCT.

In participants with R/R DLBCL ineligible ASCT.

In participants with previously untreated FL.

In participants with FL who achieved a CR or PR after receiving SOC treatment in 1L or 2L.

In participants with previously untreated DLBCL who are ineligible to receive full-dose anthracycline.

In participants with FL who progressed within 24 months of initiation of first-line anti-CD20-containing immunochemotherapy.

In participants with R/R DLBCL eligible for ASCT.

Outcomes

Primary Outcome Measures

Part 1: Number of Participants With Dose limiting Toxicities (DLTs)
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.
Part 1 and Part 2 (Arm 7): Number of Participants With Adverse Events (AEs)
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.
Part 2 (Except Arm 7): Overall Response Rate (ORR)
ORR is defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on Lugano criteria.

Secondary Outcome Measures

Part 1 and 2: Clearance (CL) of Epcoritamab
Part 1 and 2: Volume of Distribution (Vd) of Epcoritamab
Part 1 and 2: Area Under the Concentration-Time Curve (AUC) from Time Zero to Last Quantifiable Dose (AUC0-last) of Epcoritamab
Part 1 and 2: Area Under the Concentration-Time Curve (AUC) from Time Zero to Infinity (AUC0-inf) of Epcoritamab
Part 1 and 2: Maximum (Peak) Plasma Concentration (Cmax) of Epcoritamab
Part 1 and 2: Time to Reach Cmax (Tmax) of Epcoritamab
Part 1 and 2: Terminal Elimination Half-Life (t 1/2) of Epcoritamab
Part 1 and 2: Plasma Trough (Pre-dose) Concentrations (Ctrough) of Epcoritamab
Part 1 and 2: Number of Immune Cell Populations
Immune cell populations in peripheral blood and tumor biopsies will be assessed.
Part 1 and 2: Percentage of Immune Cell Populations
Immune cell populations in peripheral blood and tumor biopsies will be assessed.
Part 1 and 2: Change From Baseline in Cytokine Levels up to Cycle 3
Change in cytokine levels in peripheral blood samples will be assessed.
Part 1 and 2: Change From Baseline in Circulating Tumor Deoxyribonucleic Acid (DNA) Level up to End of Treatment (up to 2 Years)
Change in circulating tumor DNA levels will be assessed.
Part 1 and 2: Number of Participants With Anti-Drug Antibodies (ADAs) to Epcoritamab
Part 1: ORR
ORR is defined as the percentage of participants achieving CR or PR based on Lugano criteria.
Part 1 and 2: Duration of Response (DOR)
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.
Part 1 and 2: Time to Response (TTR)
TTR is defined as the time from Day 1 of Cycle 1 to first documentation of objective tumor response (CR or PR).
Part 1 and 2: Progression Free Survival (PFS)
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.
Part 1 and 2: Overall Survival (OS)
OS is defined as the time from the date of first dose, to the date of death due to any cause.
Part 1 and 2: Time to Next Anti-lymphoma Therapy (TTNT)
TTNT is defined as the time from Day 1 of Cycle 1 to first documented administration of subsequent anti-lymphoma therapy.
Part 1 and 2: Percentage of Participants With Minimal Residual Disease (MRD) Negativity
It is defined as the percentage of participants with at least 1 MRD negative result.
Part 1 and 2: Duration of minimal residual disease (MRD) negativity
Part 2 (Arm 7): Percentage of Participants Who Converted From MRD Positivity to MRD Negativity
Part 2 (Except Arm 7): Percentage of Participants with Complete Response (CR) in Arms 1 to 10
Part 2 (Arm 7): Percentage of Participants With CR
It is defined as the percentage of participants who remain in complete remission or converting to complete remission after first trial drug administration.
Part 1 and 2: Time to Complete Response (TTCR)
TTCR is defined as the time from first trial drug administration to the date of first documented complete response post-treatment.
Part 1 and 2: Duration of Complete Response (DoCR)
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.

Full Information

First Posted
October 27, 2020
Last Updated
August 7, 2023
Sponsor
Genmab
Collaborators
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT04663347
Brief Title
Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)
Acronym
EPCORE™ NHL-2
Official 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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 3, 2020 (Actual)
Primary Completion Date
March 31, 2029 (Anticipated)
Study Completion Date
March 31, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genmab
Collaborators
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A phase 1b/2, open-label, multinational, interventional trial to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics/biomarkers, immunogenicity, and preliminary efficacy of epcoritamab (EPKINLY™) in combination with other standard of care (SOC) agents in participants with B-cell Non-Hodgkin Lymphoma (B-NHL).
Detailed Description
All participants in the trial will receive epcoritamab, as monotherapy or in combination. The following regimens will be investigated: Arm 1: epcoritamab + rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in participants with previously untreated diffuse large B-cell lymphoma (DLBCL) Arm 2: epcoritamab + rituximab and lenalidomide (R2) in participants with relapsed/refractory (R/R) follicular lymphoma (FL) Arm 3: epcoritamab + rituximab and bendamustine (BR) in participants with previously untreated FL Arm 4: epcoritamab + rituximab, cytarabine, dexamethasone, and oxaliplatin/ carboplatin (R-DHAX/C) in participants with R/R DLBCL eligible for autologous stem cell transplant (ASCT) Arm 5: epcoritamab + gemcitabine and oxaliplatin (GemOx) in participants with R/R DLBCL ineligible for ASCT due to age, performance status (PS), or comorbidity Arm 6: epcoritamab + R2 in participants with previously untreated FL Arm 7: epcoritamab maintenance in participants with FL who achieve a complete response (CR) or a partial response (PR) with SOC treatment Arm 8: epcoritamab + reduced dose of R-CHOP (R mini-CHOP) in participants with previously untreated DLBCL who are ineligible to receive full-dose anthracycline Arm 9: epcoritamab + lenalidomide for second-line treatment in participants with FL who progressed within 24 months of initiation of first-line anti-CD20-containing immunochemotherapy Arm 10: epcoritamab + rituximab, ifosfamide, carboplatin, and etoposide phosphate (R-ICE) in participants with R/R DLBCL eligible for ASCT The trial consists of two parts: Part 1 ('Dose Escalation') and Part 2 ('Dose Expansion'). The primary objective of Part 1 is safety, and it includes Arm 1-5 and Arm 10. Part 2 includes all 10 arms (Arm 1-10) and the primary goal of all arms, except Arm 7, is preliminary efficacy. For Arm 7, the primary goal is safety. Patients in Arm 1-5 and Arm 10 can only participate in either Part 1 or Part 2. Dose Limiting Toxicities (DLTs) will be assessed in Part 1 and for a selected number of patients in Arm 8 during a 28-day period ('safety-run phase'). The arms are conducted in parallel.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diffuse Large B-Cell Lymphoma, Follicular Lymphoma
Keywords
DuoBody®, monoclonal antibodies, anti-CD3, anti-CD20

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
662 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 - Epcoritamab + R-CHOP
Arm Type
Experimental
Arm Description
In participants with previously untreated DLBCL.
Arm Title
Arm 2 - Epcoritamab + R2
Arm Type
Experimental
Arm Description
In participants with R/R FL.
Arm Title
Arm 3 - Epcoritamab + BR
Arm Type
Experimental
Arm Description
In participants with previously untreated FL.
Arm Title
Arm 4 - Epcoritamab + R-DHAX/C
Arm Type
Experimental
Arm Description
In participants with R/R DLBCL eligible for ASCT.
Arm Title
Arm 5 - Epcoritamab + GemOx
Arm Type
Experimental
Arm Description
In participants with R/R DLBCL ineligible ASCT.
Arm Title
Arm 6 - Epcoritamab + R2
Arm Type
Experimental
Arm Description
In participants with previously untreated FL.
Arm Title
Arm 7 - Epcoritamab maintenance
Arm Type
Experimental
Arm Description
In participants with FL who achieved a CR or PR after receiving SOC treatment in 1L or 2L.
Arm Title
Arm 8 - Epcoritamab + R mini-CHOP
Arm Type
Experimental
Arm Description
In participants with previously untreated DLBCL who are ineligible to receive full-dose anthracycline.
Arm Title
Arm 9 - Epcoritamab + Lenalidomide
Arm Type
Experimental
Arm Description
In participants with FL who progressed within 24 months of initiation of first-line anti-CD20-containing immunochemotherapy.
Arm Title
Arm 10 - Epcoritamab + R-ICE
Arm Type
Experimental
Arm Description
In participants with R/R DLBCL eligible for ASCT.
Intervention Type
Drug
Intervention Name(s)
rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone
Other Intervention Name(s)
R-CHOP
Intervention Description
21-day cycles
Intervention Type
Drug
Intervention Name(s)
rituximab and lenalidomide
Other Intervention Name(s)
R2
Intervention Description
28-day cycles
Intervention Type
Drug
Intervention Name(s)
rituximab and bendamustine
Other Intervention Name(s)
BR
Intervention Description
28-day cycles
Intervention Type
Drug
Intervention Name(s)
rituximab, cytarabine, dexamethasone, and oxaliplatin/carboplatin
Other Intervention Name(s)
R-DHAX/C
Intervention Description
21-day cycles
Intervention Type
Drug
Intervention Name(s)
gemcitabine and oxaliplatin
Other Intervention Name(s)
GemOx
Intervention Description
28-day cycles
Intervention Type
Biological
Intervention Name(s)
Epcoritamab
Other Intervention Name(s)
GEN3013, DuoBody®-CD3xCD20, EPKINLY™
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
rituximab, cyclophosphamide, reduced dose of doxorubicin, vincristine, and prednisone
Other Intervention Name(s)
R mini-CHOP
Intervention Description
21-day cycles
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Intervention Description
28-day cycles
Intervention Type
Drug
Intervention Name(s)
rituximab, ifosfamide, carboplatin, and etoposide phosphate
Other Intervention Name(s)
R-ICE
Intervention Description
21-day cycles
Intervention Type
Biological
Intervention Name(s)
Epcoritamab
Other Intervention Name(s)
GEN3013, DuoBody®-CD3xCD20, EPKINLY™
Intervention Description
Every week in cycle 1-3, every 2 weeks in cycle 4-9, followed by every 4 weeks for a total of 2 years.
Intervention Type
Biological
Intervention Name(s)
Epcoritamab
Other Intervention Name(s)
GEN3013, DuoBody®-CD3xCD20, EPKINLY™
Intervention Description
Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until disease progression or unacceptable toxicity.
Intervention Type
Biological
Intervention Name(s)
Epcoritamab
Other Intervention Name(s)
GEN3013, DuoBody®-CD3xCD20, EPKINLY™
Intervention Description
Every week in cycle 1 and 2, followed by every 4 weeks for a total of 2 years.
Intervention Type
Biological
Intervention Name(s)
Epcoritamab
Other Intervention Name(s)
GEN3013, DuoBody®-CD3xCD20, EPKINLY™
Intervention Description
Every week in cycle 1 and then every 8 weeks for a total of 2 years.
Intervention Type
Biological
Intervention Name(s)
Epcoritamab
Other Intervention Name(s)
GEN3013, DuoBody®-CD3xCD20, EPKINLY™
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Epcoritamab
Other Intervention Name(s)
GEN3013, DuoBody®-CD3xCD20, EPKINLY™
Intervention Description
Every week in cycle 1-3 and then every 4 weeks for a total of 2 years.
Intervention Type
Biological
Intervention Name(s)
Epcoritamab
Other Intervention Name(s)
GEN3013, DuoBody®-CD3xCD20, EPKINLY™
Intervention Description
Every week in cycle 1-4, every 2 weeks in cycle 5-9 followed by every 4 weeks until transplant or disease progression.
Primary Outcome Measure Information:
Title
Part 1: Number of Participants With Dose limiting Toxicities (DLTs)
Description
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.
Time Frame
During the first cycle (Cycle length= 28 days) in each cohort
Title
Part 1 and Part 2 (Arm 7): Number of Participants With Adverse Events (AEs)
Description
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.
Time Frame
From first dose of trial medication to the maximum of 60 days after last dose of epcoritamab or initiation of subsequent anti-lymphoma therapy.
Title
Part 2 (Except Arm 7): Overall Response Rate (ORR)
Description
ORR is defined as the percentage of participants achieving complete response (CR) or partial response (PR) based on Lugano criteria.
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
Part 1 and 2: Clearance (CL) of Epcoritamab
Time Frame
Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years)
Title
Part 1 and 2: Volume of Distribution (Vd) of Epcoritamab
Time Frame
Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years)
Title
Part 1 and 2: Area Under the Concentration-Time Curve (AUC) from Time Zero to Last Quantifiable Dose (AUC0-last) of Epcoritamab
Time Frame
Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years)
Title
Part 1 and 2: Area Under the Concentration-Time Curve (AUC) from Time Zero to Infinity (AUC0-inf) of Epcoritamab
Time Frame
Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years)
Title
Part 1 and 2: Maximum (Peak) Plasma Concentration (Cmax) of Epcoritamab
Time Frame
Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years)
Title
Part 1 and 2: Time to Reach Cmax (Tmax) of Epcoritamab
Time Frame
Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years)
Title
Part 1 and 2: Terminal Elimination Half-Life (t 1/2) of Epcoritamab
Time Frame
Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years)
Title
Part 1 and 2: Plasma Trough (Pre-dose) Concentrations (Ctrough) of Epcoritamab
Time Frame
Predose and postdose at multiple timepoints until treatment discontinuation (up to 3 years)
Title
Part 1 and 2: Number of Immune Cell Populations
Description
Immune cell populations in peripheral blood and tumor biopsies will be assessed.
Time Frame
Up to 2 years
Title
Part 1 and 2: Percentage of Immune Cell Populations
Description
Immune cell populations in peripheral blood and tumor biopsies will be assessed.
Time Frame
Up to 2 years
Title
Part 1 and 2: Change From Baseline in Cytokine Levels up to Cycle 3
Description
Change in cytokine levels in peripheral blood samples will be assessed.
Time Frame
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)
Title
Part 1 and 2: Change From Baseline in Circulating Tumor Deoxyribonucleic Acid (DNA) Level up to End of Treatment (up to 2 Years)
Description
Change in circulating tumor DNA levels will be assessed.
Time Frame
Up to 2 years
Title
Part 1 and 2: Number of Participants With Anti-Drug Antibodies (ADAs) to Epcoritamab
Time Frame
Up to 3 years
Title
Part 1: ORR
Description
ORR is defined as the percentage of participants achieving CR or PR based on Lugano criteria.
Time Frame
Up to 3 years
Title
Part 1 and 2: Duration of Response (DOR)
Description
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.
Time Frame
Up to 3 years
Title
Part 1 and 2: Time to Response (TTR)
Description
TTR is defined as the time from Day 1 of Cycle 1 to first documentation of objective tumor response (CR or PR).
Time Frame
Up to 3 years
Title
Part 1 and 2: Progression Free Survival (PFS)
Description
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.
Time Frame
Up to 3 years
Title
Part 1 and 2: Overall Survival (OS)
Description
OS is defined as the time from the date of first dose, to the date of death due to any cause.
Time Frame
Up to 3 years
Title
Part 1 and 2: Time to Next Anti-lymphoma Therapy (TTNT)
Description
TTNT is defined as the time from Day 1 of Cycle 1 to first documented administration of subsequent anti-lymphoma therapy.
Time Frame
Up to 3 years
Title
Part 1 and 2: Percentage of Participants With Minimal Residual Disease (MRD) Negativity
Description
It is defined as the percentage of participants with at least 1 MRD negative result.
Time Frame
Up to 3 years
Title
Part 1 and 2: Duration of minimal residual disease (MRD) negativity
Time Frame
Up to 3 years
Title
Part 2 (Arm 7): Percentage of Participants Who Converted From MRD Positivity to MRD Negativity
Time Frame
Up to 3 years
Title
Part 2 (Except Arm 7): Percentage of Participants with Complete Response (CR) in Arms 1 to 10
Time Frame
Up to 3 years
Title
Part 2 (Arm 7): Percentage of Participants With CR
Description
It is defined as the percentage of participants who remain in complete remission or converting to complete remission after first trial drug administration.
Time Frame
Week 24, Week 48, and Week 96
Title
Part 1 and 2: Time to Complete Response (TTCR)
Description
TTCR is defined as the time from first trial drug administration to the date of first documented complete response post-treatment.
Time Frame
Up to 3 years
Title
Part 1 and 2: Duration of Complete Response (DoCR)
Description
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.
Time Frame
Up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria 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) Eastern Cooperative Oncology Group (ECOG) PS score of 0, 1 or 2 Acceptable organ function at screening CD20-positive non-Hodgkin lymphoma (NHL) at most recent representative tumor biopsy If of childbearing potential subject must practicing a highly effective method of birth control 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 Documented diffuse large B-cell lymphoma (DLBCL) DLBCL, 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 DLBCL and eligible for HDT-ASCT DLBCL, NOS "double-hit" or "triple-hit" DLBCL FL Grade 3B Arm 5: Relapsed or refractory documented 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: DLBCL, NOS 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 DLBCL and eligible for HDT-ASCT DLBCL, NOS "double-hit" or "triple-hit" DLBCL FL Grade 3B Key Exclusion Criteria Chemotherapy, radiation therapy, or major surgery within 4 weeks prior to the first dose of epcoritamab Any prior treatment with a bispecific antibody targeting CD3 and CD20. Treatment with CAR-T therapy within 30 days prior to first dose of epcoritamab Clinically significant cardiovascular disease Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results 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 Active positive tests for hepatitis B virus or hepatitis C virus indicating acute or chronic infection Known history of seropositivity of human immunodeficiency virus (HIV) Active tuberculosis or history of completed treatment for active tuberculosis within the past 12 months Neuropathy > grade 1 Receiving immunostimulatory agent Prior allogeneic HSCT Current seizure disorder requiring anti-epileptic therapy NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Genmab A/S Trial Information
Phone
+45 70202728
Email
clinicaltrials@genmab.com
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Name
David Geffen School of Medicine at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
84109
Country
United States
Individual Site Status
Recruiting
Facility Name
John Theurer Cancer Center at Hackensack UMC
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Name
Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering CC
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Name
Levine Cancer Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Name
UMPC Hillman Cancer Center Cancer Pavillion
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Recruiting
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Name
Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Individual Site Status
Completed
Facility Name
Austin Health
City
Heidelberg
ZIP/Postal Code
VIC 3084
Country
Australia
Individual Site Status
Recruiting
Facility Name
Linear Clinical Research Limited
City
Nedlands
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Recruiting
Facility Name
AZ Sint-Jan
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
CHU UCL Namur Site Godinne
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Hradec Kralove
City
Hradec Králové
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Ostrava
City
Ostrava - Poruba
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice v Motole
City
Prague
ZIP/Postal Code
15006
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Vseobecna Fakultni Nemocnice
City
Praha 2
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Århus Hospital
City
Arhus
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Odense University Hospital
City
Odense
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Vejle Sygehus
City
Vejle
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Tampere University Hospital
City
Helsinki
ZIP/Postal Code
33520
Country
Finland
Individual Site Status
Recruiting
Facility Name
Kuopio University Hospital
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
Individual Site Status
Recruiting
Facility Name
HUS Cancer Center
City
Lahti
ZIP/Postal Code
15850
Country
Finland
Individual Site Status
Recruiting
Facility Name
Institut Bergonié
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Dijon - Hopital du Bocage
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Claude Huriez - CHRU Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital de la Timone
City
Marseille
ZIP/Postal Code
13005
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Saint-Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre-Bénite
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Name
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
City
Bologna
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione del Piemonte per l Oncologia Istituto di Candiolo IRCCS
City
Candiolo
ZIP/Postal Code
10060
Country
Italy
Individual Site Status
Recruiting
Facility Name
Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
City
Milan
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia
City
Reggio Emilia
ZIP/Postal Code
42123
Country
Italy
Individual Site Status
Recruiting
Facility Name
Amsterdam UMC, Locatie VUMC
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Universitair Medisch Centrum Groningen (UMCG)
City
Groningen
ZIP/Postal Code
9713
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Leids Universitair Medisch Centrum
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Maastricht University Medical Center
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Erasmus Medisch Centrum
City
Rotterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
UMC Utrecht
City
Utrecht
ZIP/Postal Code
3584
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Oslo Universitetssykehus HF, Radiumhospitalet
City
Oslo
ZIP/Postal Code
310
Country
Norway
Individual Site Status
Recruiting
Facility Name
ICO l Hospitalet
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Södra Älvsborgs Sjukhus
City
Borås
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Sahlgrenska Sjukhuset
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Skånes Universitetssjukhus
City
Lund
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Karolinska Universitetssjukhuset
City
Solna
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Norrlands Universitetssjukhus
City
Umeå
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Akademiska Sjukhuset
City
Uppsala
Country
Sweden
Individual Site Status
Recruiting
Facility Name
University College London Hospitals
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Individual Site Status
Completed
Facility Name
The Christie NHS Foundation Trust
City
Manchester
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Freeman Hospital
City
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7D
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Derriford Hospital
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)

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