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A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma

Primary Purpose

Non-Hodgkin Lymphoma

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Epcoritamab
Lenalidomide
Ibrutinib
Rituximab
Cyclophosphamide
Doxorubicin Hydrochloride [HCl]
Prednisone
Polatuzumab Vedotin
Venetoclax
CC-99282
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin Lymphoma focused on measuring Non-Hodgkin Lymphoma, Epcoritamab, Lenalidomide, Ibrutinib, Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride (HCl], Prednisone (pola-R-CHP), ABBV-GMAB-3013, Cancer, Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL), Venetoclax,, Venclexta, ABT-199, GDC-0199, CC-99282, EPCORE

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of diffuse large B-cell lymphoma (DLBCL) (de novo or histologically transformed from follicular lymphoma or nodal marginal zone lymphoma) with histologically confirmed CD20+ disease, inclusive of the following according to World Health Organization (WHO) 2016 classification and documented in pathology report:

    • DLBCL, not otherwise specified (NOS).
    • High-grade B cell lymphoma with MYC and BCL-2 and/or BCL-6 translocations per WHO 2016 ("double-hit" or "triple-hit") Note: High-grade B-cell lymphomas NOS or other double- /triple-hit lymphomas (with histologies not consistent with DLBCL) are not eligible.
    • Follicular lymphoma Grade 3B.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.

  • Must have 1 or more measurable disease sites:

    • A positron emission tomography (PET) /computed tomography (CT) scan demonstrating PET-positive lesion(s) AND
    • At least 1 measurable nodal lesion (long axis >= 1.5cm and short axis > 1.0 cm) or >= 1 measurable extra-nodal lesion (long axis >= 1.0 cm) on CT scan or MRI.

Exclusion Criteria:

  • Prior treatment with epcoritamab or any other bispecific antibody targeting CD3 and CD20.
  • Unresolved toxicities from prior anticancer therapy, defined as having not resolved to Common Terminology Criteria for Adverse Events (CTCAE, v 5.0), Grade 2 or below, with the exception of alopecia.

Sites / Locations

  • University of Arizona Cancer Center - North Campus /ID# 242219Recruiting
  • Yale University /ID# 242089Recruiting
  • Christiana Care Health Service /ID# 242301Recruiting
  • Tampa General Hospital /ID# 246748Recruiting
  • Emory University /ID# 242153Recruiting
  • University of Maryland School of Medicine /ID# 242218Recruiting
  • Alliance for Multispecialty Research (AMR) - Kansas City /ID# 242144Recruiting
  • Northwell Health - Monter Cancer Center /ID# 245435Recruiting
  • Novant Health Presbyterian Medical Center /ID# 242148Recruiting
  • East Carolina University Brody School of Medicine /ID# 242506Recruiting
  • Novant Health Forsyth Medical Center /ID# 242198Recruiting
  • Fox Chase Cancer Center /ID# 242106Recruiting
  • Thompson Cancer Survival Ctr /ID# 242150Recruiting
  • Joe Arrington Cancer Research /ID# 242226Recruiting
  • Swedish Cancer Institute- First Hill /ID# 242269Recruiting
  • Multicare Institute for Research and Innovation /ID# 242127Recruiting
  • Fakultni Nemocnice Brno /ID# 242683Recruiting
  • Fakultni nemocnice Hradec Kralove /ID# 241722Recruiting
  • Fakultni nemocnice Ostrava /ID# 242684Recruiting
  • Vseobecna fakultni nemocnice v Praze /ID# 242685Recruiting
  • Aarhus University Hospital /ID# 242670Recruiting
  • CHU Clermont-Ferrand /ID# 242344Recruiting
  • HCL - Hopital Lyon Sud /ID# 242349Recruiting
  • CHU de Rennes - PONTCHAILLOU /ID# 242339Recruiting
  • CHRU Lille - Hopital Claude Huriez /ID# 242335Recruiting
  • Institut de Recherche Saint Louis - Hopital St Louis /ID# 242336Recruiting
  • CHRU Nancy - Hopitaux de Brabois /ID# 242342Recruiting
  • CHU de Nantes, Hotel Dieu -HME /ID# 242345Recruiting
  • Hopital Henri Mondor /ID# 242337Recruiting
  • Hopital Pitie Salpetriere /ID# 242343Recruiting
  • IUCT Oncopole /ID# 242340Recruiting
  • Debreceni Egyetem Klinikai Kozpont /ID# 242450Recruiting
  • Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 245935Recruiting
  • Semmelweis Egyetem /ID# 242454Recruiting
  • Orszagos Onkologiai Intezet /ID# 242458Recruiting
  • The Chaim Sheba Medical Center /ID# 243010Recruiting
  • Tel Aviv Sourasky Medical Center /ID# 243012Recruiting
  • Hadassah Medical Center-Hebrew University /ID# 243013Recruiting
  • Rabin Medical Center /ID# 243014Recruiting
  • Hokkaido University Hospital /ID# 248999Recruiting
  • National Cancer Center Hospital /ID# 248995Recruiting
  • Seoul National University Bundang Hospital /ID# 242404Recruiting
  • Seoul National University Hospital /ID# 242402Recruiting
  • Asan Medical Center /ID# 242400Recruiting
  • Samsung Medical Center /ID# 242401Recruiting
  • The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 242403Recruiting
  • Erasmus Medisch Centrum /ID# 243315Recruiting
  • Vrije Universiteit Medisch Centrum /ID# 243319Recruiting
  • Universitair Medisch Centrum Groningen /ID# 243318Recruiting
  • Leids Universitair Medisch Centrum /ID# 243316Recruiting
  • Maastricht Universitair Medisch Centrum /ID# 243317Recruiting
  • Instituto Catalan de Oncologia (ICO) Badalona /ID# 243265Recruiting
  • Instituto Catalan de Oncologia (ICO) L'Hospitalet /ID# 243261Recruiting
  • CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 245031Recruiting
  • Hospital Universitario Vall d'Hebron /ID# 243260Recruiting
  • CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 243268Recruiting
  • Hospital Universitario Fundacion Jimenez Diaz /ID# 243264Recruiting
  • Hospital Universitario 12 de Octubre /ID# 243262Recruiting
  • Hospital Universitario de Salamanca /ID# 243368Recruiting
  • Hospital Universitario Virgen del Rocio /ID# 243267Recruiting
  • Hospital Clinico Universitario de Valencia /ID# 243269Recruiting
  • China Medical University Hospital /ID# 242893Recruiting
  • National Cheng Kung University Hospital /ID# 242894Recruiting
  • Taipei Veterans General Hosp /ID# 242892Recruiting

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 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Arm 1: Dose Escalation

Arm 2: Dose Escalation

Arm 3: Dose Escalation

Arm 4: Dose Escalation

Arm 5: Dose Escalation

Arm 6A: Dose Escalation

Arm 6B: Dose Escalation

Arm 7: Dose Escalation

Arm 1: Dose Expansion

Arm 2: Dose Expansion

Arm 3: Dose Expansion

Arm 4: Dose Expansion

Arm 5: Dose Expansion

Arm 6: Dose Expansion

Arm 7: Dose Expansion

Arm Description

Participants with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) will receive escalating doses of subcutaneous (SC) epcoritamab in combination with oral lenalidomide in 28 day cycles.

Participants with R/R DLBCL will receive escalating doses of SC epcoritamab in combination with oral ibrutinib and oral lenalidomide in 28 day cycles.

Participants with newly diagnosed treatment-naïve DLBCL will receive escalating doses of SC epcoritamab in combination with intravenous (IV) polatuzumab vedotin, IV rituximab, IV cyclophosphamide, IV doxorubicin hydrochloride (HCl), and oral prednisone (pola-R-CHP) in 21 day cycles.

Participants with R/R DLBCL will receive escalating doses of SC epcoritamab in combination with oral CC-99282 in 28 day cycles.

Participants with R/R follicular lymphoma (FL) will receive escalating doses of SC epcoritamab in combination with oral CC-99282 in 28 day cycles.

Participants with R/R mantle cell lymphoma (MCL) will receive escalating doses of SC epcoritamab in combination with oral ibrutinib in 28 day cycles.

Participants with R/R MCL will receive escalating doses of SC epcoritamab in combination with oral ibrutinib, and oral venetoclax in 28 day cycles.

Participants with newly diagnosed treatment-naïve MCL will receive escalating doses of SC epcoritamab in combination with oral ibrutinib, and oral venetoclax in 28 day cycles.

Participants with R/R DLBCL will receive the recommended dose of SC epcoritamab in combination with oral lenalidomide in 28 day cycles.

Participants with R/R DLBCL will receive the recommended dose of SC epcoritamab in combination with oral ibrutinib and oral lenalidomide in 28 day cycles.

Participants newly diagnosed treatment-naïve DLBCL will receive the recommended dose of SC epcoritamab in combination with intravenous (IV) polatuzumab vedotin, IV rituximab, IV cyclophosphamide, IV doxorubicin hydrochloride (HCl), and oral prednisone (pola-R-CHP) in 21 day cycles.

Participants with R/R DLBCL will receive the recommended dose of SC epcoritamab in combination with oral CC-99282 in 28 day cycles.

Participants with R/R FL will receive the recommended dose of SC epcoritamab in combination with oral CC-99282 in 28 day cycles.

Participants with R/R MCL will receive the recommended dose of SC epcoritamab in combination with oral ibrutinib in 28 day cycles.

Participants with newly diagnosed treatment-naïve MCL will receive the recommended dose of SC epcoritamab in combination with oral ibrutinib, and oral venetoclax in 28 day cycles.

Outcomes

Primary Outcome Measures

Number of Participants with Dose-Limiting Toxicities (DLT)
DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.

Secondary Outcome Measures

Best Overall Response (BOR) per Investigator
BOR is defined as the percentage of participants who achieved best overall response of CR or PR by Lugano 2014 criteria as assessed by the investigator.
Duration of response (DOR) per Investigator
DOR is defined for participants who achieved best overall response of CR or PR ('responders'), as the time in months from initial CR/PR to the earliest occurrence of radiographic progression determined by Lugano 2014 criteria as assessed by the investigator, or death from any cause.
Number of Participants with Progression-free survival (PFS)
PFS is defined as the time in months from the first dose of study drug to the earliest occurrence of disease progression determined by Lugano 2014 criteria as assessed by investigator, or death from any cause.
Percentage of Participants with Complete Response (CR)
CR is defined as the percentage of participantswho achieved best overall response of CR determined by Lugano 2014 criteria as assessed by investigator.
Time-to-response (TTR)
TTR is defined as the number of months from the date of first dose to the date of best overall response of CR or PR ('responders') determined by Lugano 2014 criteria as assessed by investigator.
Time to Next Antilymphoma Therapy (TTNT)
Time to next antilymphoma therapy.
Rate of Minimal Residual Disease (MRD) Negativity
MRD is defined as the percentage of participants with assessment of the minimal residual disease.
Overall Survival (OS)
(OS) is defined as the time in months from first dose of epcoritamab to death from any cause.

Full Information

First Posted
March 9, 2022
Last Updated
October 23, 2023
Sponsor
AbbVie
Collaborators
Genmab
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1. Study Identification

Unique Protocol Identification Number
NCT05283720
Brief Title
A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma
Official Title
Phase 1b/2, Open-Label Study to Evaluate Safety and Tolerability of Epcoritamab in Combination With Anti-Neoplastic Agents in Subjects With Non-Hodgkin Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 14, 2022 (Actual)
Primary Completion Date
May 19, 2029 (Anticipated)
Study Completion Date
May 19, 2029 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
B-cell Lymphoma is an aggressive and rare cancer of a type of immune cell (a white blood cell responsible for fighting infections). The purpose of this study is to assess the safety and tolerability of epcoritamab in combination with anti-neoplastic agents in adult participants with Non-Hodgkin lymphoma (NHL). Adverse events and change in disease activity will be assessed. Epcoritamab is an investigational drug being developed for the treatment of NHL. Study doctors put the participants in groups called treatment arms. The combination of epcoritamab with anti-neoplastic agents will be explored. Each treatment arm receives a different treatment combination depending on eligibility. Approximately 394 adult participants with NHL will be enrolled in 100 sites globally. In both the dose escalation and dose expansion arms participants will receive subcutaneous (SC) epcoritamab in 28-day or 21 day cycles dependent on the arm in combination with the anti-neoplastic agents described below: 1: Oral lenalidomide in participants with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL); 2: Oral ibrutinib and oral lenalidomide in participants with with R/R DLBCL; 3: Intravenous (IV) polatuzumab vedotin, IV rituximab, IV cyclophosphamide, IV doxorubicin hydrochloride (HCl), and oral prednisone (pola-R-CHP) in participants with newly diagnosed treatment-naïve DLBCL; 4: Oral CC-99282 in participants with R/R DLBCL; 5: Oral CC-99282 in participants with R/R follicular lymphoma (FL); 6A: Oral ibrutinib in participants with R/R mantle cell lymphoma (MCL); 6B: Oral ibrutinib, and oral venetoclax in participants with R/R MCL; 7: Oral ibrutinib, and oral venetoclax in participants with newly diagnosed treatment-naïve MCL. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin Lymphoma
Keywords
Non-Hodgkin Lymphoma, Epcoritamab, Lenalidomide, Ibrutinib, Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride (HCl], Prednisone (pola-R-CHP), ABBV-GMAB-3013, Cancer, Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL), Venetoclax,, Venclexta, ABT-199, GDC-0199, CC-99282, EPCORE

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
394 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Dose Escalation
Arm Type
Experimental
Arm Description
Participants with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) will receive escalating doses of subcutaneous (SC) epcoritamab in combination with oral lenalidomide in 28 day cycles.
Arm Title
Arm 2: Dose Escalation
Arm Type
Experimental
Arm Description
Participants with R/R DLBCL will receive escalating doses of SC epcoritamab in combination with oral ibrutinib and oral lenalidomide in 28 day cycles.
Arm Title
Arm 3: Dose Escalation
Arm Type
Experimental
Arm Description
Participants with newly diagnosed treatment-naïve DLBCL will receive escalating doses of SC epcoritamab in combination with intravenous (IV) polatuzumab vedotin, IV rituximab, IV cyclophosphamide, IV doxorubicin hydrochloride (HCl), and oral prednisone (pola-R-CHP) in 21 day cycles.
Arm Title
Arm 4: Dose Escalation
Arm Type
Experimental
Arm Description
Participants with R/R DLBCL will receive escalating doses of SC epcoritamab in combination with oral CC-99282 in 28 day cycles.
Arm Title
Arm 5: Dose Escalation
Arm Type
Experimental
Arm Description
Participants with R/R follicular lymphoma (FL) will receive escalating doses of SC epcoritamab in combination with oral CC-99282 in 28 day cycles.
Arm Title
Arm 6A: Dose Escalation
Arm Type
Experimental
Arm Description
Participants with R/R mantle cell lymphoma (MCL) will receive escalating doses of SC epcoritamab in combination with oral ibrutinib in 28 day cycles.
Arm Title
Arm 6B: Dose Escalation
Arm Type
Experimental
Arm Description
Participants with R/R MCL will receive escalating doses of SC epcoritamab in combination with oral ibrutinib, and oral venetoclax in 28 day cycles.
Arm Title
Arm 7: Dose Escalation
Arm Type
Experimental
Arm Description
Participants with newly diagnosed treatment-naïve MCL will receive escalating doses of SC epcoritamab in combination with oral ibrutinib, and oral venetoclax in 28 day cycles.
Arm Title
Arm 1: Dose Expansion
Arm Type
Experimental
Arm Description
Participants with R/R DLBCL will receive the recommended dose of SC epcoritamab in combination with oral lenalidomide in 28 day cycles.
Arm Title
Arm 2: Dose Expansion
Arm Type
Experimental
Arm Description
Participants with R/R DLBCL will receive the recommended dose of SC epcoritamab in combination with oral ibrutinib and oral lenalidomide in 28 day cycles.
Arm Title
Arm 3: Dose Expansion
Arm Type
Experimental
Arm Description
Participants newly diagnosed treatment-naïve DLBCL will receive the recommended dose of SC epcoritamab in combination with intravenous (IV) polatuzumab vedotin, IV rituximab, IV cyclophosphamide, IV doxorubicin hydrochloride (HCl), and oral prednisone (pola-R-CHP) in 21 day cycles.
Arm Title
Arm 4: Dose Expansion
Arm Type
Experimental
Arm Description
Participants with R/R DLBCL will receive the recommended dose of SC epcoritamab in combination with oral CC-99282 in 28 day cycles.
Arm Title
Arm 5: Dose Expansion
Arm Type
Experimental
Arm Description
Participants with R/R FL will receive the recommended dose of SC epcoritamab in combination with oral CC-99282 in 28 day cycles.
Arm Title
Arm 6: Dose Expansion
Arm Type
Experimental
Arm Description
Participants with R/R MCL will receive the recommended dose of SC epcoritamab in combination with oral ibrutinib in 28 day cycles.
Arm Title
Arm 7: Dose Expansion
Arm Type
Experimental
Arm Description
Participants with newly diagnosed treatment-naïve MCL will receive the recommended dose of SC epcoritamab in combination with oral ibrutinib, and oral venetoclax in 28 day cycles.
Intervention Type
Drug
Intervention Name(s)
Epcoritamab
Other Intervention Name(s)
ABBV-GMAB-3013;
Intervention Description
Subcutaneous Injection (SC)
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Intervention Description
Oral; Capsule
Intervention Type
Drug
Intervention Name(s)
Ibrutinib
Other Intervention Name(s)
Imbruvica
Intervention Description
Oral; Capsule
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
Intravenous (IV); Injection
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
IV; Injection
Intervention Type
Drug
Intervention Name(s)
Doxorubicin Hydrochloride [HCl]
Intervention Description
IV; Injection
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
Oral; Tablet
Intervention Type
Drug
Intervention Name(s)
Polatuzumab Vedotin
Intervention Description
IV; Injection
Intervention Type
Drug
Intervention Name(s)
Venetoclax
Other Intervention Name(s)
Venclexta;, ABT-199, GDC-0199
Intervention Description
Oral; Tablet
Intervention Type
Drug
Intervention Name(s)
CC-99282
Intervention Description
Oral; Capsule
Primary Outcome Measure Information:
Title
Number of Participants with Dose-Limiting Toxicities (DLT)
Description
DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.
Time Frame
Up to Approximately 5 Years
Secondary Outcome Measure Information:
Title
Best Overall Response (BOR) per Investigator
Description
BOR is defined as the percentage of participants who achieved best overall response of CR or PR by Lugano 2014 criteria as assessed by the investigator.
Time Frame
Up to Approximately 5 Years
Title
Duration of response (DOR) per Investigator
Description
DOR is defined for participants who achieved best overall response of CR or PR ('responders'), as the time in months from initial CR/PR to the earliest occurrence of radiographic progression determined by Lugano 2014 criteria as assessed by the investigator, or death from any cause.
Time Frame
Up to Approximately 5 Years
Title
Number of Participants with Progression-free survival (PFS)
Description
PFS is defined as the time in months from the first dose of study drug to the earliest occurrence of disease progression determined by Lugano 2014 criteria as assessed by investigator, or death from any cause.
Time Frame
Up to Approximately 5 Years
Title
Percentage of Participants with Complete Response (CR)
Description
CR is defined as the percentage of participantswho achieved best overall response of CR determined by Lugano 2014 criteria as assessed by investigator.
Time Frame
Up to Approximately 5 Years
Title
Time-to-response (TTR)
Description
TTR is defined as the number of months from the date of first dose to the date of best overall response of CR or PR ('responders') determined by Lugano 2014 criteria as assessed by investigator.
Time Frame
Up to Approximately 5 Years
Title
Time to Next Antilymphoma Therapy (TTNT)
Description
Time to next antilymphoma therapy.
Time Frame
Up to Approximately 5 Years
Title
Rate of Minimal Residual Disease (MRD) Negativity
Description
MRD is defined as the percentage of participants with assessment of the minimal residual disease.
Time Frame
Up to Approximately 5 Years
Title
Overall Survival (OS)
Description
(OS) is defined as the time in months from first dose of epcoritamab to death from any cause.
Time Frame
Up to Approximately 5 Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of: -- Diffuse large B-cell lymphoma (DLBCL) (de novo or histologically transformed from follicular lymphoma (FL) or nodal marginal zone lymphoma) with histologically confirmed CD20+ disease, inclusive of the following according to World Health Organization (WHO) 2016 classification and documented in pathology report: DLBCL, not otherwise specified (NOS). High-grade B cell lymphoma with MYC and BCL-2 and/or BCL-6 translocations per WHO 2016 ("double-hit" or "triple-hit") Note: High-grade B-cell lymphomas NOS or other double- /triple-hit lymphomas (with histologies not consistent with DLBCL) are not eligible. Follicular lymphoma (FL) Grade 3B. OR FL with histologically confirmed CD20+ Grade 1 to 3a and no evidence of histologic transformation to an aggressive lymphoma at most recent representative tumor biopsy, according to WHO 2016 classification. OR Mantle cell lymphoma (MCL) with histologically confirmed CD20+ disease at most recent representative tumor biopsy according to the WHO 2016 classification with evidence of overexpression of cyclin D1 in association with relevant markers or evidence of t(11;14) assessed by flow cytometry, FISH, or polymerase chain reaction (PCR). Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2, except for Arms 6 and 7 where ECOG performance status must be 0-1. Must have 1 or more measurable disease sites: A positron emission tomography (PET) /computed tomography (CT) scan demonstrating PET-positive lesion(s) AND At least 1 measurable nodal lesion (long axis > 1.5 cm) or >= 1 measurable extra-nodal lesion (long axis > 1.0 cm) on CT scan or magnetic resonance imaging (MRI). Exclusion Criteria: Prior treatment with epcoritamab or any other bispecific antibody targeting CD3 and CD20. Toxicities from prior anticancer therapy, defined as having not resolved to Common Terminology Criteria for Adverse Events (CTCAE, v 5.0), Grade 2 or below, with the exception of alopecia. Other eligibility criteria (e.g., laboratory, cardiac criteria) must also be met.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABBVIE CALL CENTER
Phone
844-663-3742
Email
abbvieclinicaltrials@abbvie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
University of Arizona Cancer Center - North Campus /ID# 242219
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719-1478
Country
United States
Individual Site Status
Recruiting
Facility Name
Yale University /ID# 242089
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Recruiting
Facility Name
Christiana Care Health Service /ID# 242301
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Individual Site Status
Recruiting
Facility Name
Tampa General Hospital /ID# 246748
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Recruiting
Facility Name
Emory University /ID# 242153
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322-1013
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Maryland School of Medicine /ID# 242218
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201-1544
Country
United States
Individual Site Status
Recruiting
Facility Name
Alliance for Multispecialty Research (AMR) - Kansas City /ID# 242144
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114-4859
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwell Health - Monter Cancer Center /ID# 245435
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Individual Site Status
Recruiting
Facility Name
Novant Health Presbyterian Medical Center /ID# 242148
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Name
East Carolina University Brody School of Medicine /ID# 242506
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Individual Site Status
Recruiting
Facility Name
Novant Health Forsyth Medical Center /ID# 242198
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Recruiting
Facility Name
Fox Chase Cancer Center /ID# 242106
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Individual Site Status
Recruiting
Facility Name
Thompson Cancer Survival Ctr /ID# 242150
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37916
Country
United States
Individual Site Status
Recruiting
Facility Name
Joe Arrington Cancer Research /ID# 242226
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Individual Site Status
Recruiting
Facility Name
Swedish Cancer Institute- First Hill /ID# 242269
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Individual Site Status
Recruiting
Facility Name
Multicare Institute for Research and Innovation /ID# 242127
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Individual Site Status
Recruiting
Facility Name
Fakultni Nemocnice Brno /ID# 242683
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Hradec Kralove /ID# 241722
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Fakultni nemocnice Ostrava /ID# 242684
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Vseobecna fakultni nemocnice v Praze /ID# 242685
City
Praha
ZIP/Postal Code
128 08
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Aarhus University Hospital /ID# 242670
City
Aarhus N
State/Province
Midtjylland
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Name
CHU Clermont-Ferrand /ID# 242344
City
Clermont
State/Province
Auvergne-Rhone-Alpes
ZIP/Postal Code
63100
Country
France
Individual Site Status
Recruiting
Facility Name
HCL - Hopital Lyon Sud /ID# 242349
City
Pierre Benite CEDEX
State/Province
Auvergne-Rhone-Alpes
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Rennes - PONTCHAILLOU /ID# 242339
City
Rennes
State/Province
Bretagne
ZIP/Postal Code
35000
Country
France
Individual Site Status
Recruiting
Facility Name
CHRU Lille - Hopital Claude Huriez /ID# 242335
City
Lille
State/Province
Hauts-de-France
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Name
Institut de Recherche Saint Louis - Hopital St Louis /ID# 242336
City
Paris
State/Province
Ile-de-France
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Name
CHRU Nancy - Hopitaux de Brabois /ID# 242342
City
Vandoeuvre-les-Nancy
State/Province
Meurthe-et-Moselle
ZIP/Postal Code
54500
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Nantes, Hotel Dieu -HME /ID# 242345
City
Nantes
State/Province
Pays-de-la-Loire
ZIP/Postal Code
44000
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Henri Mondor /ID# 242337
City
Creteil
ZIP/Postal Code
94000
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Pitie Salpetriere /ID# 242343
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Name
IUCT Oncopole /ID# 242340
City
Toulouse Cedex 9
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Name
Debreceni Egyetem Klinikai Kozpont /ID# 242450
City
Debrecen
State/Province
Hajdu-Bihar
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 245935
City
Kaposvár
State/Province
Somogy
ZIP/Postal Code
7400
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Semmelweis Egyetem /ID# 242454
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Orszagos Onkologiai Intezet /ID# 242458
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Individual Site Status
Recruiting
Facility Name
The Chaim Sheba Medical Center /ID# 243010
City
Ramat Gan
State/Province
Tel-Aviv
ZIP/Postal Code
5265601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Tel Aviv Sourasky Medical Center /ID# 243012
City
Tel Aviv-Yafo
State/Province
Tel-Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Recruiting
Facility Name
Hadassah Medical Center-Hebrew University /ID# 243013
City
Jerusalem
State/Province
Yerushalayim
ZIP/Postal Code
91120
Country
Israel
Individual Site Status
Recruiting
Facility Name
Rabin Medical Center /ID# 243014
City
Petakh Tikva
ZIP/Postal Code
4941492
Country
Israel
Individual Site Status
Recruiting
Facility Name
Hokkaido University Hospital /ID# 248999
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Cancer Center Hospital /ID# 248995
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0045
Country
Japan
Individual Site Status
Recruiting
Facility Name
Seoul National University Bundang Hospital /ID# 242404
City
Seongnam
State/Province
Gyeonggido
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital /ID# 242402
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Center /ID# 242400
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center /ID# 242401
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 242403
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Erasmus Medisch Centrum /ID# 243315
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3015 GD
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Vrije Universiteit Medisch Centrum /ID# 243319
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Universitair Medisch Centrum Groningen /ID# 243318
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Leids Universitair Medisch Centrum /ID# 243316
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Maastricht Universitair Medisch Centrum /ID# 243317
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Instituto Catalan de Oncologia (ICO) Badalona /ID# 243265
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Name
Instituto Catalan de Oncologia (ICO) L'Hospitalet /ID# 243261
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Name
CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 245031
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Vall d'Hebron /ID# 243260
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 243268
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Fundacion Jimenez Diaz /ID# 243264
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 12 de Octubre /ID# 243262
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario de Salamanca /ID# 243368
City
Salamanca
ZIP/Postal Code
37711
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen del Rocio /ID# 243267
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinico Universitario de Valencia /ID# 243269
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Name
China Medical University Hospital /ID# 242893
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Cheng Kung University Hospital /ID# 242894
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Veterans General Hosp /ID# 242892
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/

Learn more about this trial

A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma

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