A Sub-study Trial of Epcoritamab vs Investigator's Choice Chemotherapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL) in China
NCT ID: NCT07226752
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
72 participants
INTERVENTIONAL
2022-10-08
2028-06-14
Brief Summary
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Epcoritamab will be injected under the skin. Investigator's choice chemotherapy will be given intravenously.
Trial details include:
The trial duration will be up to 5 years after last participant is randomized. All trial participants have a 21-day screening period, a treatment period, and a follow-up period that continues until death.
The estimated trial duration for an individual participant depends upon the treatment arm assigned:
Participants who receive epcoritamab will have 28-day treatment cycles. Epcoritamab will be given once weekly for the first 3 months, then every other week for 6 months, then every 28 days until lymphoma progression or unacceptable adverse events.
Participants who receive investigator's choice (standard of care) chemotherapy will receive treatments either:
R-GemOx: On Day 1 (or Day 1 \& Day 2), and Day 15 (or Day 15 \& Day 16) every 28 days, for up to 4 months; or BR: On Day 1 and Day 2 every 3 weeks for up to 4.5 months.
Detailed Description
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This study is a sub-study of the master protocol GCT3013-05 (NCT04628494).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Epcoritamab (GEN3013; DuoBody®CD3xCD20)
Epcoritamab will be administered in Cycles of 28 days until any of the discontinuation criteria is met.
Epcoritamab
Following mandatory pre-medication, participants will be administered epcoritamab as a subcutaneous injection.
Investigator's choice of chemotherapy
R-GemOx will be administrated in Cycles of 28 days until maximum cycles completion or any of the discontinuation criteria is met
BR will be administrated in Cycles of 21 days until maximum cycles completion or any of the discontinuation criteria is met
Investigator's Choice Chemotherapy
Following mandatory pre-medication, participants will be administered intravenously either BR or R-GemOx.
Interventions
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Epcoritamab
Following mandatory pre-medication, participants will be administered epcoritamab as a subcutaneous injection.
Investigator's Choice Chemotherapy
Following mandatory pre-medication, participants will be administered intravenously either BR or R-GemOx.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. One of the confirmed histologies below with CD20-positivity:
1\. DLBCL, not otherwise specified (NOS), including de novo or histologically transformed from follicular lymphoma (FL) 2. "Double-hit" or "triple-hit" DLBCL (technically classified in World Health Organization (WHO) 2016 as high-grade B-cell lymphoma (HGBCL), with MYC and BCL2 and/or BCL6 translocations), including de novo or histologically transformed from FL 3. FL Grade 3B 4. T-cell/histiocyte-rich large B-cell lymphoma
3\. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0-2 4. Failed previous HDT-ASCT or not eligible for high-dose therapy autologous stem cell transplant (HDT-ASCT) at screening 5. Participants must have detectable disease by positron emission tomography (PET) scan and measurable by computed tomography (CT) scan or magnetic resonance imaging (MRI) 6. Acceptable renal and liver function 7. Life expectancy \>2 months on standard of care treatment
Exclusion Criteria
2. Any prior therapy with a bispecific antibody targeting CD3 and CD20
3. Major surgery within 4 weeks prior to randomization
4. Chemotherapy and other non-investigational antineoplastic agents (except CD20 mAbs) within 4 weeks or 5 half-lives (whichever is shorter) prior to randomization
5. Any investigational drug within 4 weeks or 5 half-lives, whichever is longer, prior to randomization
6. Autologous stem cell transplant (ASCT) within 100 days of randomization
7. Treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 100 days prior to randomization
8. Seizure disorder requiring anti-epileptic therapy
9. Clinically significant cardiac disease
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Genmab
INDUSTRY
Responsible Party
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Principal Investigators
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Study Official
Role: STUDY_DIRECTOR
Genmab
Locations
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Affiliated Hospital of Hebei University
Baoding, , China
Beijing Cancer Hospital
Beijing, , China
Beijing Tongren Hospital, Capital Medical University
Beijing, , China
Peking University Third Hospital
Beijing, , China
The First Hospital of Jilin University
Changchun, , China
West China Hospital, Sichuan University
Chengdu, , China
The Second Hospital of Dalian Medical University
Dalian, , China
Guangdong Provincial Peoples Hospital
Guandong, , China
Guangxi Medical University Affiliated Tumor Hospital
Guangxi, , China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, , China
Hubei Cancer Hospital
Hubei, , China
Hunan Cancer Hospital
Hunan, , China
The First Affiliated Hospital of Nanchang University
Nanchang, , China
Qingdao Central Hospital
Qingdao, , China
Shanxi Provincial Cancer Hospital
Shanxi, , China
Shengjing Hospital of China Medical University
Shenyang, , China
Shenzhen Peoples Hospital
Shenzhen, , China
The First Affiliated Hospital of Soochow University
Suzhou, , China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, , China
EC of Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, , China
Yantai Yuhuangding Hospital
Yantai, , China
Henan Cancer Hospital
Zhengzhou, , China
The Second Affiliated Hospital Zhejiang University School of Medicine
Zhenjiang, , China
Countries
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Other Identifiers
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CTR20221558
Identifier Type: REGISTRY
Identifier Source: secondary_id
GCT3013-05 Sub-study
Identifier Type: -
Identifier Source: org_study_id