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

  • STATUS
    Recruiting
  • End date
    Jan 15, 2024
  • participants needed
    66
  • sponsor
    AbbVie
Updated on 7 October 2022
cancer
cyclophosphamide
rituximab
vincristine
monoclonal antibodies
prednisone
measurable disease
experimental drug
follicular lymphoma
cancer chemotherapy
diffuse large b-cell lymphoma
marginal zone lymphoma
large b-cell lymphoma
r-chop
anti-cd20 monoclonal antibody
fludeoxyglucose f-18

Summary

B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). The purpose of this study is to assess the safety and toxicity of epcoritamab as a monotherapy and when combined with standard of care therapy [Rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) or Rituximab and lenalidomide (R2)] in adult participants in China with B-Cell Non-Hodgkin Lymphoma. Adverse events and change in disease activity will be assessed.

Epcoritamab is an investigational drug being developed for the treatment of B-Cell Non-Hodgkin Lymphoma. Study doctors put the participants in groups called treatment arms. A monotherapy of epcoritamab and two different combination of epcoritamab with standard of care therapy (R-CHOP or R2) will be explored. Each treatment arm receives a different treatment combination depending on stage of the study and eligibility. Approximately 66 adult participants with B-Cell Non-Hodgkin Lymphoma will be enrolled in the study in approximately 21 sites in China.

In the monotherapy arm (Cohort 1), participants will receive subcutaneous epcoritamab in 28-day cycles. In the combination arms (Cohorts 2 and 3), participants in Cohort 2 will receive subcutaneous epcoritamab with standard of care therapy (R-CHOP) in 21-day cycles followed by 28-day cycles, participants in Cohort 3 will receive subcutaneous epcoritamab with standard of care therapy (R2) in 28-day cycles.

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.

Details
Condition B-Cell Non-Hodgkin Lymphoma
Treatment Rituximab, cyclophosphamide, prednisone, vincristine, doxorubicin, Lenalidomide, Epcoritamab
Clinical Study IdentifierNCT05201248
SponsorAbbVie
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

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
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
Cohort 2 Specific Criteria
Must have newly diagnosed DLBCL
Following safety run-in and up to the 12th participant (including the number of safety
Double-/triple-hit DLBCL (categorized in WHO 2016 as high-grade B-cell lymphoma [HGBCL] with MYC and BCL2 and/or BCL6 rearrangements)
run-in participants) in Cohort 1, participant must have received at least 1
Note: other histologies with MYC and BCL2 and/or BCL6 translocations are excluded
prior line of systemic therapies which must include an anti-CD20 monoclonal
Eligible for standard R-CHOP for 6 cycles
antibody containing combination therapy (e.g., rituximab). After 12
participants have been enrolled at dose A of epcoritamab, participants must
Cohort 3 Specific Criteria
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 be eligible for R2 per investigator determination
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
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
Cohort 2 Specific Criteria
History of prior systemic anti-lymphoma therapy (including definitive radiotherapy) for Diffuse large B-cell lymphoma (DLBCL) other than corticosteroids
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
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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