A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab As Monotherapy or Combined With Standard of Care Therapies in Adult Participants in China With B-Cell Non-Hodgkin Lymphoma
B-Cell Non-Hodgkin Lymphoma
About this trial
This is an interventional treatment trial for B-Cell Non-Hodgkin Lymphoma focused on measuring B-Cell Non-Hodgkin Lymphoma, Epcoritamab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, R-CHOP, Rituximab, Lenalidomide, R2, ABBV-GMAB-3013, Cancer, EPCORE
Eligibility Criteria
Inclusion Criteria:
All Cohorts:
- Must have an Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 2.
Has one or more measurable disease sites:
- Fluorodeoxyglucose-positron emission tomography (FDGPET) scan demonstrating positive lesion compatible with computed tomography (CT) or magnetic resonance image (MRI)-defined anatomical tumor sites.
- >= 1 measurable nodal lesion (long axis >= 1.5 cm and short axis > 1.0 cm) or >= 1 measurable extra-nodal lesion (long axis >= 1 cm) on CT scan or MRI. Note: A previously irradiated lesion must have demonstrated progression or residual disease in the lesion after radiotherapy to be considered measurable.
Cohort 1 Part 1 (Monotherapy Safety Run-in) Specific Criteria:
- Must have histologically confirmed CD20+ Diffuse large B-cell lymphoma (DLBCL), or High-grade B-cell lymphoma (HGCBL) with MYC and BCL2 and/or BCL6 translocations and DLBCL feature, and follicular Lymphoma (FL) at most recent (previous or current) representative tumor biopsy based on the pathology report, according to the World Health Organization (WHO) 2016 classification.
- Must have at least one prior treatment with an anti-CD20 monoclonal antibody (e.g., rituximab) potentially in combination with chemotherapy and/or relapsed after autologous stem cell rescue.
- Must have relapsed or refractory disease. Relapsed disease is defined as disease that has recurred >= 6 months after completion of therapy. Refractory disease is defined as disease that either progressed during therapy or progressed within 6 months (<6 months) of completion of therapy.
Cohort 1 Part 2 (Monotherapy Expansion) Specific Criteria:
Must have histologically confirmed DLBCL and documented in pathology report, inclusive of the following pathology report, according to the World Health Organization (WHO) 2016 classification.
- DLBCL, not otherwise specified (NOS) including de novo or histologically transformed from an earlier diagnosis of indolent lymphoma such as FL and nodal marginal zone lymphoma with a subsequent development of DLBCL relapse or.
- "Double-hit" or "triple-hit" with DLBCL morphology (technically classified in WHO 2016 as HGBCL, with MYC and BCL2 and/or BCL6 translocations). Note: Double- /triple-hit lymphomas without DLBCL morphology and those classified in WHO 2016 as HGBCL, NOS are not eligible.
- FL Grade 3B.
- Following safety run-in and up to the 12th participant (including the number of safety run-in participants) in Cohort 1, participant must have received at least 1 prior line of systemic therapies which must include an anti-CD20 monoclonal antibody containing combination therapy (e.g., rituximab). After 12 participants have been enrolled at dose A of epcoritamab, participants must have received at least 2 prior lines of systemic therapies.
- Must have either failed prior autologous HSCT, or be ineligible for autologous HSCT due to age, comorbidities, performance status, comorbidities, or insufficient response to prior treatment.
- Must have relapsed or refractory disease.
Cohort 2 Specific Criteria:
- Must have newly diagnosed DLBCL.
Double-/triple-hit DLBCL (categorized in WHO 2016 as high-grade B-cell lymphoma [HGBCL] with MYC and BCL2 and/or BCL6 rearrangements)*
* Note: other histologies with MYC and BCL2 and/or BCL6 translocations are excluded.
- Eligible for standard R-CHOP for 6 cycles.
Cohort 3 Specific Criteria:
- Must have histologically confirmed Grade 1 - 3a Follicular Lymphoma stage II, III, or IV with no evidence of histologic transformation to an aggressive lymphoma at most recent (previous or current) representative tumor biopsy and CD20+ on a representative tumor biopsy based on the pathology report, according to the WHO 2016 classification.
- Must have R/R disease to at least one prior systemic anti-lymphoma treatment which must include an anti CD20 monoclonal antibody (e.g., rituximab). Participant who received only prior anti-CD20 monoclonal antibody monotherapy is not eligible. Note: Relapsed disease is defined as disease that previously responded to therapy but progressed >= 6 months after completion of therapy. Refractory disease is defined as disease that either progressed during therapy, failed to achieve an objective response or progressed within 6 months (< 6 months) of completion of therapy.
- Must be eligible for R2 per investigator determination.
- Willing to take aspirin prophylaxis (participants with low or intermediate risk for thromboembolism) or prophylactic anticoagulant (if high risk for a thromboembolic event) (lenalidomide treated participants only).
Exclusion Criteria:
All Cohorts:
- History of primary mediastinal lymphoma.
- Autologous Stem Cell Transplantation within 100 days prior to enrollment.
- Have received prior allogeneic hematopoietic stem cell transplantation at any time.
- Have been treated with a bispecific antibody targeting CD3 and CD20.
Cohort 2 Specific Criteria:
- History of prior systemic anti-lymphoma therapy (including definitive radiotherapy) for Diffuse large B-cell lymphoma (DLBCL) other than corticosteroids.
Sites / Locations
- Peking University Third Hospital /ID# 228138Recruiting
- Fujian Medical University Union Hospital /ID# 231890Recruiting
- Sun Yat-Sen University Cancer Center /ID# 228033Recruiting
- Guangdong Provincial People's Hospital /ID# 228028Recruiting
- Nanfang Hospital of Southern Medical University /ID# 227916Recruiting
- Henan Cancer Hospital /ID# 228772Recruiting
- Hunan Cancer Hospital /ID# 231859Recruiting
- The First Affiliated Hospital of Soochow University /ID# 228024Recruiting
- The Affiliated Hospital of Xuzhou Medical University /ID# 228774Recruiting
- The First Affiliated Hospital of Nanchang University /ID# 228771Recruiting
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 227724Recruiting
- West China Hospital, Sichuan University /ID# 231434Recruiting
- Tianjin Medical University Cancer Institute and Hospital /ID# 228135Recruiting
- The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 228154Recruiting
- Zhejiang Cancer hospital /ID# 228776Recruiting
- The Fifth Medical Center of PLA General Hospital /ID# 230520Recruiting
- Jiangxi Cancer Hospital /ID# 231944Recruiting
- Union Hospital affiliated to Tongji Medical College of Huazhong University of Sc /ID# 231221Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Cohort 1 Part 1: Epcoritamab Monotherapy
Cohort 1 Part 2: Epcoritamab Expansion
Cohort 2: Epcoritamab + RCHOP
Cohort 3: Epcoritamab + R2
Participants will receive subcutaneous (SC) epcoritamab in 28 day cycles.
Participants will receive SC epcoritamab in 28 day cycles.
Participants will receive SC epcoritamab in combination with [intravenously (IV) infused rituximab, IV injected cyclophosphamide, IV infused doxorubicin, IV infused vincristine, and oral prednisone (R-CHOP)] in 21 day cycles followed by 28 day cycles.
Participants will receive SC epcoritamab in combination with [intravenously (IV) infused rituximab, and oral lenalidomide (R2)] in 28 day cycles.