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
18 Years and older, Male and Female
M22-132 (primary)
NCI-2022-03844
2021-005725-24
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.
Eligibility
- 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).
Treatment Sites in Georgia
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
Click here to learn more about clinical trials.