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JOURNAL ONKOLOGIE – STUDIE

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

Rekrutierend

NCT-Nummer:
NCT05283720

Studienbeginn:
Juni 2022

Letztes Update:
07.05.2024

Wirkstoff:
Epcoritamab, Lenalidomide, Ibrutinib, Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride [HCl], Prednisone, Polatuzumab Vedotin, Venetoclax, CC-99282

Indikation (Clinical Trials):
Lymphoma, Lymphoma, Non-Hodgkin

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 2

Sponsor:
Genmab

Collaborator:
AbbVie

Studienleiter

ABBVIE INC.
Study Director
AbbVie

Kontakt

Studienlocations
(3 von 74)

Universitaetsklinikum Ulm /ID# 244265
89081 Ulm
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Leipzig /ID# 245513
04103 Leipzig
(Sachsen)
GermanyRekrutierend» Google-Maps
Klinikum Augsburg /ID# 244523
86156 Augsburg
(Bayern)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Giessen und Marburg /ID# 245308
35043 Marburg
(Hessen)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Regensburg /ID# 244517
93042 Regensburg
(Bayern)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Wuerzburg /ID# 245453
97080 Wuerzburg
(Bayern)
GermanyRekrutierend» Google-Maps
University of Arizona Cancer Center - North Campus /ID# 242219
85719-1478 Tucson
United StatesRekrutierend» Google-Maps
Yale University School of Medicine /ID# 242089
06510 New Haven
United StatesRekrutierend» Google-Maps
Christiana Care Health Service /ID# 242301
19713 Newark
United StatesRekrutierend» Google-Maps
Tampa General Hospital /ID# 246748
33606 Tampa
United StatesRekrutierend» Google-Maps
Emory University /ID# 242153
30322-1013 Atlanta
United StatesRekrutierend» Google-Maps
University of Maryland Medical Center /ID# 242218
21201 Baltimore
United StatesRekrutierend» Google-Maps
Alliance for Multispecialty Research (AMR) - Kansas City /ID# 242144
64114-4859 Kansas City
United StatesRekrutierend» Google-Maps
Northwell Health - Monter Cancer Center /ID# 245435
11042 Lake Success
United StatesRekrutierend» Google-Maps
Icahn School of Medicine at Mount Sinai /ID# 242123
10029 New York
United StatesRekrutierend» Google-Maps
Novant Health Presbyterian Medical Center /ID# 242148
28204 Charlotte
United StatesRekrutierend» Google-Maps
East Carolina University - Brody School of Medicine /ID# 242506
27834 Greenville
United StatesRekrutierend» Google-Maps
Novant Health Forsyth Medical Center /ID# 242198
27103 Winston-Salem
United StatesRekrutierend» Google-Maps
Thomas Jefferson University /ID# 242077
19107-4414 Philadelphia
United StatesRekrutierend» Google-Maps
Fox Chase Cancer Center /ID# 242106
19111 Philadelphia
United StatesAbgeschlossen» Google-Maps
Thompson Cancer Survival Ctr /ID# 242150
37916 Knoxville
United StatesRekrutierend» Google-Maps
Joe Arrington Cancer Research /ID# 242226
79410 Lubbock
United StatesRekrutierend» Google-Maps
Swedish Cancer Institute- First Hill /ID# 242269
98104 Seattle
United StatesRekrutierend» Google-Maps
Multicare Institute for Research and Innovation /ID# 242127
98405 Tacoma
United StatesRekrutierend» Google-Maps
Fakultni nemocnice Brno /ID# 242683
613 00 Brno
CzechiaRekrutierend» Google-Maps
Fakultni nemocnice Hradec Kralove /ID# 241722
500 05 Hradec Kralove
CzechiaRekrutierend» Google-Maps
Fakultni Nemocnice Ostrava /ID# 242684
708 52 Ostrava
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Vseobecna fakultni nemocnice v Praze /ID# 242685
128 08 Praha
CzechiaRekrutierend» Google-Maps
Aarhus Universitetshospital - Skejby /ID# 242670
8200 Aarhus
DenmarkRekrutierend» Google-Maps
Aalborg University Hospital /ID# 242734
9000 Aalborg
DenmarkRekrutierend» Google-Maps
CHU Clermont-Ferrand /ID# 242344
63100 Clermont
FranceRekrutierend» Google-Maps
CHU de Rennes - PONTCHAILLOU /ID# 242339
35000 Rennes
FranceRekrutierend» Google-Maps
Institut de Recherche Saint Louis - Hopital St Louis /ID# 242336
75010 Paris
FranceRekrutierend» Google-Maps
CHRU Nancy - Hopitaux de Brabois /ID# 242342
54500 Vandoeuvre-les-Nancy
FranceRekrutierend» Google-Maps
CHRU Lille - Hopital Claude Huriez /ID# 242335
59037 Lille
FranceRekrutierend» Google-Maps
CHU de Nantes, Hotel Dieu -HME /ID# 242345
44000 Nantes
FranceRekrutierend» Google-Maps
HCL - Hopital Lyon Sud /ID# 242349
69495 Pierre Benite CEDEX
FranceRekrutierend» Google-Maps
Hôpitaux Universitaires Henri Mondor - Hôpital Henri Mondor /ID# 242337
94010 Créteil
FranceRekrutierend» Google-Maps
Hopital Pitie Salpetriere /ID# 242343
75013 Paris
FranceRekrutierend» Google-Maps
IUCT Oncopole /ID# 242340
31059 Toulouse Cedex 9
FranceRekrutierend» Google-Maps
Debreceni Egyetem-Klinikai Kozpont /ID# 242450
4032 Debrecen
HungaryRekrutierend» Google-Maps
Somogy Varmegyei Kaposi Mor Oktato Korhaz /ID# 245935
7400 Kaposvár
HungaryRekrutierend» Google-Maps
Semmelweis Egyetem /ID# 242454
1085 Budapest
HungaryRekrutierend» Google-Maps
Orszagos Onkologiai Intezet /ID# 242458
1122 Budapest
HungaryRekrutierend» Google-Maps
The Chaim Sheba Medical Center /ID# 243010
5265601 Ramat Gan
IsraelRekrutierend» Google-Maps
Tel Aviv Sourasky Medical Center /ID# 243012
6423906 Tel Aviv
IsraelRekrutierend» Google-Maps
Hadassah Medical Center-Hebrew University /ID# 243013
91120 Jerusalem
IsraelRekrutierend» Google-Maps
Rabin Medical Center /ID# 243014
4941492 Haifa
IsraelRekrutierend» Google-Maps
Hokkaido University Hospital /ID# 248999
060-8648 Sapporo-shi
JapanRekrutierend» Google-Maps
Kyoto University Hospital /ID# 248997
606-8507 Kyoto-shi
JapanRekrutierend» Google-Maps
National Cancer Center Hospital /ID# 248995
104-0045 Chuo-ku
JapanRekrutierend» Google-Maps
Seoul National University Bundang Hospital /ID# 242404
13620 Seongnam-si
Korea, Republic ofRekrutierend» Google-Maps
Asan Medical Center /ID# 242400
05505 Seoul
Korea, Republic ofRekrutierend» Google-Maps
The Catholic University of Korea, Seoul St. Marys Hospital /ID# 242403
06591 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Seoul National University Hospital /ID# 242402
03080 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Samsung Medical Center /ID# 242401
06351 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Duplicate_Erasmus Medisch Centrum /ID# 243315
3015 GD Rotterdam
NetherlandsAbgeschlossen» Google-Maps
Vrije Universiteit Medisch Centrum /ID# 243319
1081 HV Amsterdam
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Universitair Medisch Centrum Groningen /ID# 243318
9713 GZ Groningen
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Leids Universitair Medisch Centrum /ID# 243316
2333 ZA Leiden
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Maastricht Universitair Medisch Centrum /ID# 243317
6229 HX Maastricht
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Instituto Catalan de Oncologia (ICO) Badalona /ID# 243265
08916 Badalona
SpainRekrutierend» Google-Maps
Instituto Catalan de Oncologia (ICO) L'Hospitalet /ID# 243261
08908 Hospitalet de Llobregat
SpainRekrutierend» Google-Maps
Clinica Universidad de Navarra - Pamplona /ID# 245031
31008 Pamplona
SpainRekrutierend» Google-Maps
Hospital Universitario Vall d'Hebron /ID# 243260
08035 Barcelona
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CLINICA UNIVERSIDAD DE NAVARRA-Madrid /ID# 243268
28027 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario Fundacion Jimenez Diaz /ID# 243264
28040 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario 12 de Octubre /ID# 243262
28041 Madrid
SpainRekrutierend» Google-Maps
Hospital Universitario de Salamanca /ID# 243368
37711 Salamanca
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Hospital Universitario Virgen del Rocio /ID# 243267
41013 Sevilla
SpainRekrutierend» Google-Maps
Hospital Clinico Universitario de Valencia /ID# 243269
46010 Valencia
SpainRekrutierend» Google-Maps
China Medical University Hospital /ID# 242893
40447 Taichung
TaiwanRekrutierend» Google-Maps
National Cheng Kung University Hospital /ID# 242894
704 Tainan
TaiwanRekrutierend» Google-Maps
Taipei Veterans General Hosp /ID# 242892
11217 Taipei
TaiwanRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

1. Number of Participants with Dose-Limiting Toxicities (DLT) (Time Frame - 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:

1. Best Overall Response (BOR) per Investigator (Time Frame - Up to Approximately 5 Years):
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.

2. Duration of response (DOR) per Investigator (Time Frame - 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) (Time Frame - 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) (Time Frame - 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) (Time Frame - 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 Antilymphoma Therapy (TTNT) (Time Frame - Up to Approximately 5 Years):
Time to next antilymphoma therapy.

7. Rate of Minimal Residual Disease (MRD) Negativity (Time Frame - Up to Approximately 5 Years):
MRD is defined as the percentage of participants with assessment of the minimal residual disease.

8. Overall Survival (OS) (Time Frame - Up to Approximately 5 Years):
(OS) is defined as the time in months from first dose of epcoritamab to death from any cause.

Studien-Arme

  • 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.
  • 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.
  • 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.
  • Experimental: Arm 4: Dose Escalation
    Participants with R/R DLBCL will receive escalating doses of SC epcoritamab in combination with oral CC-99282 in 28 day cycles.
  • Experimental: Arm 5: Dose Escalation
    Participants with R/R follicular lymphoma (FL) will receive escalating doses of SC epcoritamab in combination with oral CC-99282 in 28 day cycles.
  • Experimental: Arm 6A: Dose Escalation
    Participants with R/R mantle cell lymphoma (MCL) will receive escalating doses of SC epcoritamab in combination with oral ibrutinib in 28 day cycles.
  • Experimental: Arm 6B: Dose Escalation
    Participants with R/R MCL will receive escalating doses of SC epcoritamab in combination with oral ibrutinib, and oral venetoclax in 28 day cycles.
  • Experimental: Arm 7: Dose Escalation
    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.
  • 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.
  • 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.
  • 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.
  • Experimental: Arm 4: Dose Expansion
    Participants with R/R DLBCL will receive the recommended dose of SC epcoritamab in combination with oral CC-99282 in 28 day cycles.
  • Experimental: Arm 5: Dose Expansion
    Participants with R/R FL will receive the recommended dose of SC epcoritamab in combination with oral CC-99282 in 28 day cycles.
  • Experimental: Arm 6: Dose Expansion
    Participants with R/R MCL will receive the recommended dose of SC epcoritamab in combination with oral ibrutinib in 28 day cycles.
  • Experimental: Arm 7: Dose Expansion
    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.

Geprüfte Regime

  • Epcoritamab (ABBV-GMAB-3013;):
    Subcutaneous Injection (SC)
  • Lenalidomide:
    Oral; Capsule
  • Ibrutinib (Imbruvica):
    Oral; Capsule
  • Rituximab:
    Intravenous (IV); Injection
  • Cyclophosphamide:
    IV; Injection
  • Doxorubicin Hydrochloride [HCl]:
    IV; Injection
  • Prednisone:
    Oral; Tablet
  • Polatuzumab Vedotin:
    IV; Injection
  • Venetoclax (Venclexta; / ABT-199 / GDC-0199 / ):
    Oral; Tablet
  • CC-99282:
    Oral; Capsule

Quelle: ClinicalTrials.gov


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