Clinical trial NCT06508658: A Study of Subcutaneously Injected Epcoritamab Plus Oral Lenalidomide Tablets Compared to Intravenously (IV) Infused Rituximab Plus IV Infused Gemcitabine and IV Infused Oxaliplatin in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Official title: A Phase 3, Multicenter, Randomized, Open-Label Study of Epcoritamab Plus Lenalidomide Compared to Rituximab Plus Gemcitabine and Oxaliplatin in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Diffuse Large B-Cell Lymphoma
Keywords: Epcoritamab
Lenalidomide
Rituximab
Gemcitabine
Oxaliplatin
Diffuse Large B-Cell Lymphoma
DLBCL
Epkinly
ABBV-GMAB-3013
Lead sponsor: Genmab
Sponsor class: INDUSTRY
Collaborators: name: AbbVie
First posted: 2024-07-18
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). This study will assess how safe and effective epcoritamab plus lenalidomide (E-Len) is compared to rituximab plus gemcitabine and oxaliplatin (R-GemOx) )in treating adult participants with relapsed or refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL). Adverse events and change in disease condition will be assessed.

Epcoritamab is an investigational drug being developed for the treatment of DLBCL. Study doctors put the participants in 1 of 3 groups, called treatment arms. Each group receives a different treatment. Around 360 adult participants with R/R DLBCL will be enrolled in approximately 165 sites across the world.

Participants in arm A will receive subcutaneous (SC) injections of epcoritamab plus oral lenalidomide capsules (E-Len) for up to 12 cycles (each cycle is 28 days). Participants in arm B will receive intravenously (IV) infused R-GemOx for up to 4 cycles (each cycle is 28 days). Participants in arm C will receive SC injections of epcoritamab for up to 12 cycles (each cycle is 28 days).

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 a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility criteria: Inclusion Criteria:

* Eastern Cooperative Oncology Group Performance status score of 0 to 2.
* Histologically confirmed CD20+ Diffuse Large B-Cell Lymphoma (DLBCL) and documented in the most recent and representative pathology report, inclusive of the following according to the World Health Organization (WHO) 2022 as per the protocol.
* Must have relapsed or refractory (R/R) disease and have been previously treated with at least 1 line of systemic antineoplastic therapy including anti-CD20 mAb-containing combination chemotherapy since DLBCL diagnosis.
* Participant must meet at least 1 of the following criteria:

  * Failed prior autologous stem cell transplant (ASCT), defined as relapsed after ASCT or been refractory to high-dose therapy (HDT)-ASCT.
  * Not be considered a candidate for ASCT due to age, performance status, comorbidities and/or insufficient response to prior treatment, or have refused ASCT.
  * Be ineligible for or unable to receive chimeric antigen receptor T-cell (CAR-T) meeting at least 1 of the following criteria:

    * Unable to receive CAR-T therapy due to fitness and/or comorbidity.
    * Lymphocyte apheresis failure.
    * Unwilling to receive CAR-T therapy.
    * Unable to receive CAR-T therapy due to financial, geographic, insurance, access, and/or manufacturing constraints.
    * Relapsed/progressed after having achieved at least a Partial Response (PR) or Complete Response (CR) while on prior CAR-T therapy.
* Must have measurable disease.
* Life expectancy \> 3 months on standard of care treatment at the time of enrolling in the study

Exclusion Criteria:

* Current evidence of primary central nervous system (CNS) lymphoma or known CNS involvement by lymphoma including leptomeningeal disease, at screening.
* History of prior treatment with a bispecific antibody targeting CD3 and CD20 or prior treatment with rituximab plus gemcitabine and oxaliplatin (R-GemOx) or gemcitabine and oxaliplatin (GemOx).
* Documented refractoriness to lenalidomide.

Primary outcomes:
measure: Arm A vs Arm B: Progression-Free Survival (PFS)
timeFrame: Up to 4 Years
Secondary outcomes:
measure: Arm A vs Arm B: Percentage of Participants Who Achieve Complete response (CR)
timeFrame: Up to 4 Years
measure: Arm A vs Arm B: Overall Survival (OS)
timeFrame: Up to 4 Years
measure: Arm A vs Arm B: Percentage of Participants Who Achieve Minimal Residual Disease (MRD) Negativity Rate
timeFrame: Up to 4 Years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Valkyrie Clinical Trials /ID# 269935
state: California
city: Golden
country: United States
facility: Lutheran Medical Center- Cancer Centers of Colorado /ID# 265823
state: Colorado
city: Dyer
country: United States
facility: Northwest Cancer Center - Dyer Clinic /ID# 269787
state: Indiana
city: Wichita
country: United States
facility: Cancer Center of Kansas - Wichita /ID# 270117
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky Chandler Medical Center /ID# 242087
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland, Baltimore /ID# 242216
state: Maryland
city: Gulfport
country: United States
facility: Gulfport Memorial Hospital /ID# 268104
state: Mississippi
city: Valhalla
country: United States
facility: New York Medical College /ID# 265799
state: New York
city: Knoxville
country: United States
facility: Thompson Cancer Survival Ctr /ID# 242149
state: Tennessee
city: Ogden
country: United States
facility: Community Cancer Trials Of Utah /ID# 271715
state: Utah
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists - Salt Lake City /ID# 268603
state: Utah
city: Salt Lake City
country: United States
facility: Veterans Affairs Medical Center - Salt Lake City /ID# 265329
state: Utah
city: Canberra
country: Australia
facility: Canberra Hospital /ID# 265312
state: Australian Capital Territory
city: Sydney
country: Australia
facility: Royal Prince Alfred Hospital /ID# 263242
state: New South Wales
city: Wollongong
country: Australia
facility: Wollongong Hospital /ID# 244646
state: New South Wales
city: Toowoomba
country: Australia
facility: Toowoomba Hospital /ID# 263243
state: Queensland
city: Clayton
country: Australia
facility: Monash Health - Monash Medical Centre /ID# 262783
state: Victoria
city: Perth
country: Australia
facility: Royal Perth Hospital /ID# 243790
state: Western Australia
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel /ID# 242574
state: Bruxelles-Capitale
city: Boussu
country: Belgium
facility: Centre Hospitalier Epicura - site d'Hornu /ID# 265148
state: Hainaut
city: Yvoir
country: Belgium
facility: Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant /ID# 242565
state: Namur
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven /ID# 246671
state: Vlaams-Brabant
city: Roeselare
country: Belgium
facility: AZ-Delta /ID# 264740
state: West-Vlaanderen
city: Plovdiv
country: Bulgaria
facility: UMHAT Sveti Georgi /ID# 242905
city: Sofia
country: Bulgaria
facility: UMHAT Sveti Ivan Rilski /ID# 242389
city: Sofia
country: Bulgaria
facility: SHAT Hematologic Diseases /ID# 242708
city: Varna
country: Bulgaria
facility: UMHAT Sveta Marina /ID# 262761
city: Montreal
country: Canada
facility: CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 262751
state: Quebec
city: Beijing
country: China
facility: Peking University Third Hospital /ID# 242941
state: Beijing
city: Fuzhou
country: China
facility: Fujian Province Cancer Hospital /ID# 265075
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen /ID# 264305
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center /ID# 242712
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital /ID# 242942
state: Guangdong
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University /ID# 242944
state: Hebei
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital /Id# 242961
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital /ID# 242700
state: Henan
city: Wuhan
country: China
facility: Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 242702
state: Hubei
city: Wuhan
country: China
facility: Hubei Cancer Hospital /ID# 242963
state: Hubei
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University /ID# 242939
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University /ID# 242703
state: Jiangxi
city: Nanchang
country: China
facility: Jiangxi Provincial Cancer Hospital /ID# 242968
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University /ID# 242940
state: Jilin
city: Shenyang
country: China
facility: The First Hospital of China Medical University /ID# 242701
state: Liaoning
city: Jinan
country: China
facility: Shandong Cancer Hospital /ID# 264036
state: Shandong
city: Shanghai
country: China
facility: Shanghai Tongji Hospital /ID# 263952
state: Shanghai
city: Tianjin
country: China
facility: Tianjin Cancer Hospital /ID# 243940
state: Tianjin
city: Tianjin
country: China
facility: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 243139
state: Tianjin
city: Urumqi
country: China
facility: The Affiliated Cancer Hospital of Xinjiang Medical University /ID# 242966
state: Xinjiang
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 242960
state: Zhejiang
city: Hangzhou
country: China
facility: The second affiliated hospital of Zhejiang University school of medicine /ID# 243137
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Cancer hospital /ID# 242711
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University /ID# 263951
state: Zhejiang
city: Zagreb
country: Croatia
facility: Klinicka bolnica Merkur /ID# 262619
state: Grad Zagreb
city: Zagreb
country: Croatia
facility: Klinicki bolnicki centar Sestre milosrdnice /ID# 262620
state: Grad Zagreb
city: Zagreb
country: Croatia
facility: Klinicki bolnicki centar Zagreb /ID# 262617
state: Grad Zagreb
city: Osijek
country: Croatia
facility: Klinicki bolnicki centar Osijek /ID# 262621
state: Osjecko-baranjska Zupanija
city: Rijeka
country: Croatia
facility: Klinički Bolnički Centar Rijeka /ID# 266004
state: Primorsko-goranska Zupanija
city: Split
country: Croatia
facility: Klinicki Bolnicki Centar (KBC) Split /ID# 262618
state: Splitsko-dalmatinska Zupanija
city: Hradec Králové
country: Czechia
facility: Fakultní nemocnice Hradec Králové - Sokolská /ID# 264071
state: Hradec Kralove
city: Tours CEDEX 9
country: France
facility: CHRU Tours - Hopital Bretonneau /ID# 244580
state: Indre-et-Loire
city: Avignon
country: France
facility: Centre Hospitalier D'Avignon /ID# 243072
state: Provence-Alpes-Cote-d Azur
city: Bayonne
country: France
facility: Centre Hospitalier de la Cote Basque /ID# 243065
state: Pyrenees-Atlantiques
city: Poitiers
country: France
facility: CHU Poitiers - La miletrie /ID# 243074
state: Vienne
city: Caen
country: France
facility: CHU de CAEN - Hopital de la Cote de Nacre /ID# 243075
city: Lille Cedex
country: France
facility: Hopital Saint Vincent de Paul /ID# 243070
city: Strasbourg
country: France
facility: Institut de cancérologie Strasbourg Europe (ICANS) /ID# 264068
city: Athens
country: Greece
facility: General Hospital of Athens Laiko /ID# 262809
state: Attiki
city: Athens
country: Greece
facility: University General Hospital Attikon /ID# 242041
state: Attiki
city: Athens
country: Greece
facility: General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 242039
city: Thessaloniki
country: Greece
facility: General University Hospital of Thessaloniki AXEPA /ID# 242038
city: Thessaloniki
country: Greece
facility: Theageneio Anticancer Hospital /ID# 242036
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem Klinikai Kozpont /ID# 262924
state: Baranya
city: Gyor
country: Hungary
facility: Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz /ID# 262901
state: Gyor-Moson-Sopron
city: Debrecen
country: Hungary
facility: Debreceni Egyetem-Klinikai Kozpont /ID# 242451
state: Hajdu-Bihar
city: Nyiregyhaza
country: Hungary
facility: Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz /ID# 242468
state: Szabolcs-Szatmar-Bereg
city: Budapest
country: Hungary
facility: Semmelweis Egyetem /ID# 242455
city: Budapest
country: Hungary
facility: Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 262923
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet /ID# 242457
city: Toyoake
country: Japan
facility: Fujita Health University Hospital /ID# 265968
state: Aichi
city: Matsuyama
country: Japan
facility: National Hospital Organization Shikoku Cancer Center /ID# 265977
state: Ehime
city: Fukuoka-shi
country: Japan
facility: Kyushu University Hospital /ID# 267624
state: Fukuoka
city: Fukushima-shi
country: Japan
facility: Fukushima Medical University Hospital /ID# 264667
state: Fukushima
city: Sapporo
country: Japan
facility: Sapporo Medical University Hospital /ID# 264928
state: Hokkaido
city: Kagoshima-shi
country: Japan
facility: Kagoshima University Hospital /ID# 248259
state: Kagoshima
city: Isehara
country: Japan
facility: Tokai University Hospital /ID# 265433
state: Kanagawa
city: Hirakata-shi
country: Japan
facility: Kansai Medical University Hospital /ID# 266018
state: Osaka
city: Osakasayama-shi
country: Japan
facility: Kindai University Hospital /ID# 265474
state: Osaka
city: Kitaadachi-gun
country: Japan
facility: Saitama Cancer Center /ID# 265277
state: Saitama
city: Chuo
country: Japan
facility: University of Yamanashi Hospital /ID# 264671
state: Yamanashi
city: Busan
country: Korea, Republic of
facility: Inje University - Busan Paik Hospital /ID# 262842
state: Busan Gwang Yeogsi
city: Busan
country: Korea, Republic of
facility: Dong-A University Medical Center /ID# 262841
state: Busan Gwang Yeogsi
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital /ID# 242405
state: Gyeonggido
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital /ID# 262840
state: Gyeongsangbugdo
city: Jeonju
country: Korea, Republic of
facility: Jeonbuk National University Hospital /ID# 242958
state: Jeonrabugdo
city: Hwasun-gun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital /ID# 262843
state: Jeonranamdo
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 242407
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center /ID# 242409
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center /ID# 242408
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Marys Hospital /ID# 242406
state: Seoul Teugbyeolsi
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital /ID# 242956
state: Ulsan Gwang Yeogsi
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden /ID# 245501
state: Friesland
city: 's-Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis, locatie 's-Hertogenbosch /ID# 265204
state: Noord-Brabant
city: Amsterdam
country: Netherlands
facility: OLVG - Locatie Oost /ID# 263355
state: Noord-Holland
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis /ID# 245197
state: Utrecht
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis, locatie Dordwijk /ID# 263361
state: Zuid-Holland
city: Auckland
country: New Zealand
facility: North Shore Hospital /ID# 266060
city: Wellington
country: New Zealand
facility: Wellington Hospital /ID# 265966
city: Krakow
country: Poland
facility: Pratia MCM Krakow /ID# 262882
state: Malopolskie
city: Warsaw
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Bada /ID# 263314
state: Mazowieckie
city: Kielce
country: Poland
facility: Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej /ID# 242436
state: Swietokrzyskie
city: Poznan
country: Poland
facility: Aidport sp z o.o. /ID# 262766
state: Wielkopolskie
city: Lisbon
country: Portugal
facility: Hospital da Luz /ID# 262965
state: Lisboa
city: Porto
country: Portugal
facility: Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE /ID# 262961
city: Porto
country: Portugal
facility: Unidade Local de Saude de Sao Joao, EPE /ID# 262962
city: Bucharest
country: Romania
facility: Fundeni Clinical Institute /ID# 266734
state: Bucuresti
city: Cluj Napoca
country: Romania
facility: Institutul Oncologic Prof Dr I Chiricuta /ID# 243753
state: Cluj
city: Jassi
country: Romania
facility: Institutul Regional de Oncologie /ID# 244367
state: Iasi
city: Bucharest
country: Romania
facility: Spitalul Clinic Coltea /ID# 243694
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Zvezdara /ID# 263059
state: Beograd
city: Belgrade
country: Serbia
facility: Institute for Oncology and Radiology of Serbia /ID# 263055
state: Beograd
city: Belgrade
country: Serbia
facility: University Clinical Center Serbia /ID# 263057
state: Beograd
city: Belgrade
country: Serbia
facility: Clinical Hospital Center - Bežanijska Kosa /ID# 263053
state: Beograd
city: Niš
country: Serbia
facility: University Clinical Center Nis /ID# 263701
state: Nisavski Okrug
city: Sremska Kamenica
country: Serbia
facility: Institute for Oncology of Vojvodina /ID# 263052
state: Vojvodina
city: Novi Sad
country: Serbia
facility: University Clinical Center Vojvodina /ID# 264138
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore /ID# 267015
state: Central Singapore
city: Singapore
country: Singapore
facility: National University Hospital /ID# 264016
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital /ID# 266061
city: Johannesburg
country: South Africa
facility: Wits Clinical Research /ID# 264656
state: Gauteng
city: Pretoria
country: South Africa
facility: Alberts Cellular Therapy /ID# 262720
state: Gauteng
city: Kuilsrivier
country: South Africa
facility: Haemalife Inc. /ID# 262719
state: Western Cape
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital /ID# 243300
state: Taipei
city: Taichung
country: Taiwan
facility: China Medical University Hospital /ID# 242931
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital /ID# 242937
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital /ID# 243301
city: Ankara
country: Turkey
facility: Ankara Universitesi Fakultesi /ID# 242410
city: Aydin
country: Turkey
facility: Adnan Menderes University /ID# 242418
city: Edirne, Istanbul
country: Turkey
facility: Trakya University Medical Facu /ID# 242419
city: Samsun
country: Turkey
facility: Ondokuz mayis University Facul /ID# 242412
city: Trabzon
country: Turkey
facility: Karadeniz Technical University Farabi Hospital /ID# 264694
city: Şişli
country: Turkey
facility: Istanbul Florence Nightingale Hospital /ID# 271544
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital /ID# 265129
state: Nottinghamshire
city: Newcastle upon Tyne
country: United Kingdom
facility: The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 242923
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: