Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL) (EPCORE™ NHL-2)

  • STATUS
    Recruiting
  • End date
    Nov 30, 2024
  • participants needed
    396
  • sponsor
    Genmab
Updated on 2 May 2022
cyclophosphamide
cytarabine
rituximab
vincristine
prednisone
measurable disease
dexamethasone
doxorubicin
lenalidomide
carboplatin
diffuse large b-cell lymphoma
b-cell lymphoma
large b-cell lymphoma
bendamustine

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 in combination with other standard of care (SOC) agents in subjects with B-cell Non-Hodgkin Lymphoma (B-NHL).

Description

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 subjects with previously untreated diffuse large B-cell lymphoma (DLBCL)
  • Arm 2: epcoritamab + rituximab and lenalidomide (R2) in subjects with relapsed/refractory (R/R) follicular lymphoma (FL)
  • Arm 3: epcoritamab + rituximab and bendamustine (BR) in subjects with previously untreated FL
  • Arm 4: epcoritamab + rituximab, cytarabine, dexamethasone, and oxaliplatin/ carboplatin (R-DHAX/C) in subjects with R/R DLBCL eligible for autologous stem cell transplant (ASCT)
  • Arm 5: epcoritamab + gemcitabine and oxaliplatin (GemOx) in subjects with R/R DLBCL ineligible for ASCT due to age, performance status (PS), or comorbidity
  • Arm 6: epcoritamab + R2 in subjects with previously untreated FL
  • Arm 7: epcoritamab maintenance in subjects 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 subjects with previously untreated DLBCL who are ineligible to receive full-dose anthracycline

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. Part 2 includes all 8 arms (Arm 1-8) 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 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.

Details
Condition Diffuse Large B-Cell Lymphoma, Follicular Lymphoma
Treatment gemcitabine and oxaliplatin, Epcoritamab, rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone, rituximab and lenalidomide, rituximab and bendamustine, rituximab, cisplatin, cytarabine, and dexamethasone, rituximab, cytarabine, dexamethasone, and oxaliplatin/carboplatin, Epcoritamab Maintenance, rituximab, cyclophosphamide, reduced dose of doxorubicin, vincristine, and prednisone
Clinical Study IdentifierNCT04663347
SponsorGenmab
Last Modified on2 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Subject must sign an Informed Consent Form (ICF)
At least 18 years of age
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
DLBCL, NOS
Arm 4
Documented DLBCL and eligible for HDT-ASCT
double-hit" or "triple-hit" DLBCL
FL Grade 3B
DLBCL, NOS
double-hit" or "triple-hit" DLBCL
Arm 5
FL Grade 3B
Relapsed or refractory documented DLBCL and ineligible for HDT-ASCT
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

Exclusion Criteria

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)
Neuropathy > grade 1
Receiving immunostimulatory agent
Prior allogeneic HSCT
Active tuberculosis or history of completed treatment for active tuberculosis within the past 12 months
Current seizure disorder requiring anti-epileptic therapy
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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