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

Sponsor
AbbVie (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05283720
Collaborator
Genmab (Industry)
132
84
6
83.4
1.6
0

Study Details

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 132 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 combination with anti-neoplastic agents in 28-day cycles for arms 1 and 2 and 21- day cycles for arm 3.

Arm 1: SC epcoritamab in combination with oral lenalidomide in participants with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL).

Arm 2: SC epcoritamab in combination with oral ibrutinib and oral lenalidomide in participants with with R/R DLBCL.

Arm 3: SC epcoritamab in combination with 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.

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
132 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jun 14, 2022
Anticipated Primary Completion Date :
May 26, 2029
Anticipated Study Completion Date :
May 26, 2029

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm 1: Dose Escalation

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.

Drug: Epcoritamab
Subcutaneous Injection (SC)
Other Names:
  • ABBV-GMAB-3013;
  • Drug: Lenalidomide
    Oral; Capsule

    Experimental: Arm 2: Dose Escalation

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

    Drug: Epcoritamab
    Subcutaneous Injection (SC)
    Other Names:
  • ABBV-GMAB-3013;
  • Drug: Lenalidomide
    Oral; Capsule

    Drug: Ibrutinib
    Oral; Capsule

    Experimental: Arm 3: Dose Escalation

    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.

    Drug: Epcoritamab
    Subcutaneous Injection (SC)
    Other Names:
  • ABBV-GMAB-3013;
  • Drug: Rituximab
    Intravenous (IV); Injection

    Drug: Cyclophosphamide
    IV; Injection

    Drug: Doxorubicin Hydrochloride [HCl]
    IV; Injection

    Drug: Prednisone
    Oral; Tablet

    Drug: Polatuzumab
    IV; Injection

    Experimental: Arm 1: Dose Expansion

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

    Drug: Epcoritamab
    Subcutaneous Injection (SC)
    Other Names:
  • ABBV-GMAB-3013;
  • Drug: Lenalidomide
    Oral; Capsule

    Experimental: Arm 2: Dose Expansion

    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.

    Drug: Epcoritamab
    Subcutaneous Injection (SC)
    Other Names:
  • ABBV-GMAB-3013;
  • Drug: Lenalidomide
    Oral; Capsule

    Drug: Ibrutinib
    Oral; Capsule

    Experimental: Arm 3: Dose Expansion

    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.

    Drug: Epcoritamab
    Subcutaneous Injection (SC)
    Other Names:
  • ABBV-GMAB-3013;
  • Drug: Rituximab
    Intravenous (IV); Injection

    Drug: Cyclophosphamide
    IV; Injection

    Drug: Doxorubicin Hydrochloride [HCl]
    IV; Injection

    Drug: Prednisone
    Oral; Tablet

    Drug: Polatuzumab
    IV; Injection

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants with Dose-Limiting Toxicities (DLT) [Up to Approximately 5 Years]

      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

    1. Overall Response Rate (ORR) per Investigator [Up to Approximately 5 Years]

      Overall response rate (ORR) 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.

    2. Duration of response (DOR) per Investigator [Up to Approximately 5 Years]

      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.

    3. Number of Participants with Progression-free survival (PFS) [Up to Approximately 5 Years]

      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.

    4. Percentage of Participants with Complete Response (CR) [Up to Approximately 5 Years]

      CR is defined as the percentage of participantswho achieved best overall response of CR determined by Lugano 2014 criteria as assessed by investigator.

    5. Time-to-response (TTR) [Up to Approximately 5 Years]

      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.

    6. Time to Next Anti-Lymphoma Therapy (TTNT) [Up to Approximately 5 Years]

      Time to next anti-lymphoma therapy.

    7. Rate of Minimal Residual Disease (MRD) Negativity [Up to Approximately 5 Years]

      MRD is defined as the percentage of participants with assessment of the minimal residual disease.

    8. Overall Survival (OS) [Up to Approximately 5 Years]

      (OS) is defined as the time in months from first dose of epcoritamab to death from any cause.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Arizona Cancer Center - North Campus /ID# 242219 Tucson Arizona United States 85719-1478
    2 Yale University /ID# 242089 New Haven Connecticut United States 06510
    3 Christiana Care Health Service /ID# 242301 Newark Delaware United States 19713
    4 Tampa General Hospital /ID# 246748 Tampa Florida United States 33606
    5 Emory University /ID# 242153 Atlanta Georgia United States 30322-1013
    6 Augusta University Georgia Cancer Center /ID# 242140 Augusta Georgia United States 30912-0003
    7 Southern IL Univ School of Med /ID# 242229 Springfield Illinois United States 62702
    8 Univ Maryland School Medicine /ID# 242218 Baltimore Maryland United States 21201-1544
    9 Alliance for Multispecialty Research (AMR) - Kansas City /ID# 242144 Kansas City Missouri United States 64114-4859
    10 Roswell Park Comprehensive Cancer Center /ID# 242129 Buffalo New York United States 14263
    11 Northwell Health - Monter Cancer Center /ID# 245435 Lake Success New York United States 11042
    12 Icahn School of Medicine at Mount Sinai /ID# 242123 New York New York United States 10029-6504
    13 Novant Health Presbyterian Medical Center /ID# 242148 Charlotte North Carolina United States 28204
    14 East Carolina University Brody School of Medicine /ID# 242506 Greenville North Carolina United States 27834
    15 Novant Health Forsyth Medical Center /ID# 242198 Winston-Salem North Carolina United States 27103
    16 Gabrail Cancer Center Research /ID# 242212 Canton Ohio United States 44718
    17 Thomas Jefferson University /ID# 242077 Philadelphia Pennsylvania United States 19107-4414
    18 Fox Chase Cancer Center /ID# 242106 Philadelphia Pennsylvania United States 19111
    19 Thompson Cancer Survival Ctr /ID# 242150 Knoxville Tennessee United States 37916
    20 Joe Arrington Cancer Research /ID# 242226 Lubbock Texas United States 79410
    21 Swedish Cancer Institute - Edmonds /ID# 242269 Seattle Washington United States 98104
    22 Multicare Institute for Research and Innovation /ID# 242127 Tacoma Washington United States 98405
    23 BC Cancer - Vancouver /ID# 243946 Vancouver British Columbia Canada V5Z 1L3
    24 Fakultni Nemocnice Brno /ID# 242683 Brno Czechia 625 00
    25 Fakultni nemocnice Hradec Kralove /ID# 241722 Hradec Kralove Czechia 500 05
    26 Fakultni nemocnice Ostrava /ID# 242684 Ostrava Czechia 708 52
    27 Vseobecna fakultni nemocnice v Praze /ID# 242685 Praha Czechia 128 08
    28 Aarhus University Hospital /ID# 242670 Aarhus N Midtjylland Denmark 8200
    29 Aalborg University Hospital /ID# 242734 Aalborg Nordjylland Denmark 9000
    30 CHU Clermont-Ferrand /ID# 242344 Clermont Auvergne-Rhone-Alpes France 63100
    31 HCL - Hôpital Lyon Sud /ID# 242349 Pierre Benite CEDEX Auvergne-Rhone-Alpes France 69495
    32 CHU de Rennes - PONTCHAILLOU /ID# 242339 Rennes Bretagne France 35000
    33 CHRU Lille - Hopital Claude Huriez /ID# 242335 Lille Hauts-de-France France 59037
    34 Institut de Recherche Saint Louis - Hopital St Louis /ID# 242336 Paris Ile-de-France France 75010
    35 CHRU Nancy - Hôpitaux de Brabois /ID# 242342 Vandœuvre-lès-Nancy Meurthe-et-Moselle France 54500
    36 CHU de Nantes, Hotel Dieu -HME /ID# 242345 Nantes Pays-de-la-Loire France 44000
    37 Hopital Henri Mondor /ID# 242337 Creteil France 94000
    38 Hopital Pitie Salpetriere /ID# 242343 Paris France 75013
    39 IUCT Oncopole /ID# 242340 Toulouse Cedex 9 France 31059
    40 Universitaetsklinikum Ulm /ID# 244265 Ulm Baden-Wuerttemberg Germany 89081
    41 Universitatsklinikum Munster /ID# 248304 Munster Niedersachsen Germany 48149
    42 Universitaetsklinikum Koeln /ID# 244521 Köln Nordrhein-Westfalen Germany 50937
    43 Universitaetsklinikum Leipzig /ID# 245513 Leipzig Sachsen Germany 04103
    44 Klinikum Augsburg /ID# 244523 Augsburg Germany 86156
    45 Universitaetsklinikum Giessen und Marburg /ID# 245308 Marburg Germany 35043
    46 Universitaetsklinikum Regensburg /ID# 244517 Regensburg Germany 93042
    47 Universitaetsmedizin Rostock /ID# 244655 Rostock Germany 18057
    48 Universitaetsklinikum Wuerzburg /ID# 245453 Wuerzburg Germany 97080
    49 Debreceni Egyetem Klinikai Kozpont /ID# 242450 Debrecen Hajdu-Bihar Hungary 4032
    50 Somogy Megyei Kaposi Mor Oktato Korhaz /ID# 245935 Kaposvár Somogy Hungary 7400
    51 Semmelweis Egyetem /ID# 242454 Budapest Hungary 1085
    52 Orszagos Onkologiai Intezet /ID# 242458 Budapest Hungary 1122
    53 The Chaim Sheba Medical Center /ID# 243010 Ramat Gan Tel-Aviv Israel 5265601
    54 Tel Aviv Sourasky Medical Center /ID# 243012 Tel Aviv-Yafo Tel-Aviv Israel 6423906
    55 Hadassah Medical Center-Hebrew University /ID# 243013 Jerusalem Israel 91120
    56 Rabin Medical Center /ID# 243014 Petakh Tikva Israel 4941492
    57 Seoul National University Bundang Hospital /ID# 242404 Seongnam Gyeonggido Korea, Republic of 13620
    58 Seoul National University Hospital /ID# 242402 Seoul Korea, Republic of 03080
    59 Asan Medical Center /ID# 242400 Seoul Korea, Republic of 05505
    60 Samsung Medical Center /ID# 242401 Seoul Korea, Republic of 06351
    61 The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 242403 Seoul Korea, Republic of 06591
    62 Erasmus Medisch Centrum /ID# 243315 Rotterdam Zuid-Holland Netherlands 3015 GD
    63 Vrije Universiteit Medisch Centrum /ID# 243319 Amsterdam Netherlands 1081 HV
    64 Universitair Medisch Centrum Groningen /ID# 243318 Groningen Netherlands 9713 GZ
    65 Leids Universitair Medisch Centrum /ID# 243316 Leiden Netherlands 2333 ZA
    66 Maastricht Universitair Medisch Centrum /ID# 243317 Maastricht Netherlands 6229 HX
    67 Instituto Catalan de Oncologia (ICO) Badalona /ID# 243265 Badalona Barcelona Spain 08916
    68 Instituto Catalan de Oncologia (ICO) L'Hospitalet /ID# 243261 Hospitalet de Llobregat Barcelona Spain 08908
    69 CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 245031 Pamplona Navarra Spain 31008
    70 Hospital Universitario Vall d'Hebron /ID# 243260 Barcelona Spain 08035
    71 CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 243268 Madrid Spain 28027
    72 Hospital Universitario Fundacion Jimenez Diaz /ID# 243264 Madrid Spain 28040
    73 Hospital Universitario 12 de Octubre /ID# 243262 Madrid Spain 28041
    74 Hospital Universitario La Paz /ID# 243266 Madrid Spain 28046
    75 Hospital Universitario de Salamanca /ID# 243368 Salamanca Spain 37711
    76 Hospital Universitario Virgen del Rocio /ID# 243267 Sevilla Spain 41013
    77 Hospital Clinico Universitario de Valencia /ID# 243269 Valencia Spain 46010
    78 China Medical University Hospital /ID# 242893 Taichung City Taiwan 40447
    79 National Cheng Kung University Hospital /ID# 242894 Tainan Taiwan 704
    80 Taipei Veterans General Hosp /ID# 242892 Taipei City Taiwan 11217
    81 Leicester Royal Infirmary /ID# 246993 Leicester England United Kingdom LE1 5WW
    82 Guys and St Thomas NHS Foundation Trust /ID# 245056 London London, City Of United Kingdom SE1 9RT
    83 Imperial College Healthcare NHS Trust /ID# 245851 London United Kingdom W2 1NY
    84 The Christie Hospital /ID# 243948 Manchester United Kingdom M20 4BX

    Sponsors and Collaborators

    • AbbVie
    • Genmab

    Investigators

    • Study Director: ABBVIE INC., AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT05283720
    Other Study ID Numbers:
    • M22-132
    • 2021-005725-24
    First Posted:
    Mar 17, 2022
    Last Update Posted:
    Aug 25, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Keywords provided by AbbVie
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 25, 2022