Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)
a study on Diffuse Large B-Cell Lymphoma Lymphoma Non-Hodgkin Lymphoma Hodgkin's Lymphoma
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at San Francisco, California and other locations
- Dates
- study startedestimated completion
Description
Summary
A phase 1b/2, open-label, multinational, interventional trial to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics/biomarkers, immunogenicity, and preliminary efficacy of epcoritamab (EPKINLY™) in combination with other standard of care (SOC) agents in participants with B-cell Non-Hodgkin Lymphoma (B-NHL).
Official Title
A Phase 1b/2, Open-Label Trial to Assess the Safety and Preliminary Efficacy of Epcoritamab (GEN3013; DuoBody®-CD3xCD20) in Combination With Other Agents in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)
Details
All participants in the trial will receive epcoritamab, as monotherapy or in combination. The following regimens will be investigated:
- Arm 1: epcoritamab + rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in participants with previously untreated diffuse large B-cell lymphoma (DLBCL)
- Arm 2: epcoritamab + rituximab and lenalidomide (R2) in participants with relapsed/refractory (R/R) follicular lymphoma (FL)
- Arm 3: epcoritamab + rituximab and bendamustine (BR) in participants with previously untreated FL
- Arm 4: epcoritamab + rituximab, cytarabine, dexamethasone, and oxaliplatin/ carboplatin (R-DHAX/C) in participants with R/R DLBCL eligible for autologous stem cell transplant (ASCT)
- Arm 5: epcoritamab + gemcitabine and oxaliplatin (GemOx) in participants with R/R DLBCL ineligible for ASCT due to age, performance status (PS), or comorbidity
- Arm 6: epcoritamab + R2 in participants with previously untreated FL
- Arm 7: epcoritamab maintenance in participants with FL who achieve a complete response (CR) or a partial response (PR) with SOC treatment
- Arm 8: epcoritamab + reduced dose of R-CHOP (R mini-CHOP) in participants with previously untreated DLBCL who are ineligible to receive full-dose anthracycline
- Arm 9: epcoritamab + lenalidomide for second-line treatment in participants with FL who progressed within 24 months of initiation of first-line anti-CD20-containing immunochemotherapy
- Arm 10: epcoritamab + rituximab, ifosfamide, carboplatin, and etoposide phosphate (R-ICE) in participants with R/R DLBCL eligible for ASCT
The trial consists of two parts: Part 1 ('Dose Escalation') and Part 2 ('Dose Expansion'). The primary objective of Part 1 is safety, and it includes Arm 1-5 and Arm 10. Part 2 includes all 10 arms (Arm 1-10) and the primary goal of all arms, except Arm 7, is preliminary efficacy. For Arm 7, the primary goal is safety. Patients in Arm 1-5 and Arm 10 can only participate in either Part 1 or Part 2. Dose Limiting Toxicities (DLTs) will be assessed in Part 1 and for a selected number of patients in Arm 8 during a 28-day period ('safety-run phase'). The arms are conducted in parallel.
Keywords
Diffuse Large B-Cell Lymphoma, Follicular Lymphoma, DuoBody®, monoclonal antibodies, anti-CD3, anti-CD20, Lymphoma, Non-Hodgkin Lymphoma, B-Cell Lymphoma, Lymphoma, Large B-Cell, Diffuse, Cytarabine, Dexamethasone, Prednisone, Cyclophosphamide, Bendamustine Hydrochloride, Ifosfamide, Rituximab, Carboplatin, Gemcitabine, Doxorubicin, Liposomal doxorubicin, Oxaliplatin, Etoposide, Vincristine, Lenalidomide, Etoposide phosphate, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone, rituximab and lenalidomide, rituximab and bendamustine, rituximab, cytarabine, dexamethasone, and oxaliplatin/carboplatin, gemcitabine and oxaliplatin, Epcoritamab, rituximab, cyclophosphamide, reduced dose of doxorubicin, vincristine, and prednisone, rituximab, ifosfamide, carboplatin, and etoposide phosphate, Epcoritamab + R-CHOP, Epcoritamab + R2, Epcoritamab + BR, Epcoritamab + R-DHAX/C, Epcoritamab + GemOx, Epcoritamab maintenance, Epcoritamab + R mini-CHOP, Epcoritamab + Lenalidomide, Epcoritamab + R-ICE
Eligibility
You can join if…
Open to people ages 18 years and up
- Measurable disease defined as ≥1 measurable nodal lesion (long axis >1.5 cm and short axis >1.0 cm) or ≥1 measurable extra-nodal lesion (long axis >1.0 cm) on computed tomography (CT) or magnetic resonance imaging (MRI)
- Eastern Cooperative Oncology Group (ECOG) PS score of 0, 1 or 2
- Acceptable organ function at screening
- CD20-positive non-Hodgkin lymphoma (NHL) at most recent representative tumor biopsy
- If of childbearing potential subject must practicing a highly effective method of birth control
A man who is sexually active with a woman of childbearing potential must agree to use a barrier method of birth control
Arm 1:
- Newly Diagnosed Documented diffuse large B-cell lymphoma (DLBCL)
- DLBCL, NOS
- "double-hit" or "triple-hit" DLBCL
FL Grade 3B
Arm 2: R/R FL Arm 3: Newly diagnosed, previously untreated FL grade 1-3A Arm 4:
- Documented DLBCL and eligible for HDT-ASCT
- DLBCL, NOS
- "double-hit" or "triple-hit" DLBCL
FL Grade 3B
Arm 5:
- Relapsed or refractory documented DLBCL and ineligible for HDT-ASCT
- DLBCL, NOS
- "double-hit" or "triple-hit" DLBCL
FL Grade 3B
Arm 6: Newly diagnosed, previously untreated FL grade 1-3A Arm 7:
- FL Grade 1-3A
If PR or CR per Lugano criteria following first-line or second-line treatment with SOC regimen, and last dose of SOC within 6 months prior to enrollment.
Arm 8:
- DLBCL, NOS
- T-cell/histiocyte rich DLBCL
- "double-hit" or "triple-hit" DLBCL
FL Grade 3B
Arm 9:
- R/R FL
Progressed within 24 months of initiating first-line treatment
Arm 10:
- Documented DLBCL and eligible for HDT-ASCT
- DLBCL, NOS
- "double-hit" or "triple-hit" DLBCL
- FL Grade 3B
You CAN'T join if...
- Chemotherapy, radiation therapy, or major surgery within 4 weeks prior to the first dose of epcoritamab
- Any prior treatment with a bispecific antibody targeting CD3 and CD20.
- Treatment with CAR-T therapy within 30 days prior to first dose of epcoritamab
- Clinically significant cardiovascular disease
- Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
- CNS lymphoma or known CNS involvement by lymphoma at screening as confirmed by MRI/CT scan of the brain and, if clinically indicated, by lumbar puncture
- Active positive tests for hepatitis B virus or hepatitis C virus indicating acute or chronic infection
- Known history of seropositivity of human immunodeficiency virus (HIV)
Active tuberculosis or history of completed treatment for active tuberculosis within the past 12 months
10. Neuropathy > grade 1 11. Receiving immunostimulatory agent 12. Prior allogeneic HSCT 13. Current seizure disorder requiring anti-epileptic therapy NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Locations
- UCSF
accepting new patients
San Francisco California 94143 United States - Cedars-Sinai Medical Center
accepting new patients
Los Angeles California 90048 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Genmab
- ID
- NCT04663347
- Phase
- Phase 1/2 research study
- Study Type
- Interventional
- Participants
- Expecting 662 study participants
- Last Updated
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