Non Hodgkin Lymphoma Clinical Trial
Safety and Efficacy Trial of Epcoritamab Combinations in Subjects With B-cell Non-Hodgkin Lymphoma (B-NHL)
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).
Full 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 participants with previously untreated diffuse large B-cell lymphoma (DLBCL)
Arm 2: epcoritamab + rituximab and lenalidomide (R2) in participants with relapsed/refractory (R/R) 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.
Eligibility Criteria
Key Inclusion Criteria
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
Key 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)
Active tuberculosis or history of completed treatment for active tuberculosis within the past 12 months
Neuropathy > grade 1
Receiving immunostimulatory agent
Prior allogeneic HSCT
Current seizure disorder requiring anti-epileptic therapy
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 50 Locations for this study
Birmingham Alabama, 35294, United States
Los Angeles California, 90048, United States
Los Angeles California, 90095, United States
San Francisco California, 94143, United States
Boston Massachusetts, 02215, United States
Ann Arbor Michigan, 84109, United States
Hackensack New Jersey, 07601, United States
New York New York, 10029, United States
New York New York, 10065, United States
Charlotte North Carolina, 28204, United States
Pittsburgh Pennsylvania, 15232, United States
Dallas Texas, 75390, United States
Clayton Victoria, 3084, Australia
Heidelberg , VIC 3, Australia
Nedlands , 6009, Australia
Brugge , 8000, Belgium
Gent , 9000, Belgium
Yvoir , 5530, Belgium
Hradec Králové , , Czechia
Ostrava - Poruba , , Czechia
Prague , 15006, Czechia
Praha 2 , , Czechia
Arhus , , Denmark
Copenhagen , 2100, Denmark
Odense , , Denmark
Vejle , , Denmark
Helsinki , 33520, Finland
Kuopio , 70210, Finland
Lahti , 15850, Finland
Bordeaux , 33076, France
Dijon , 21000, France
Lille , 59037, France
Marseille , 13005, France
Paris , 75475, France
Pierre-Bénite , 69495, France
Bergamo , 24127, Italy
Bologna , , Italy
Candiolo , 10060, Italy
Meldola , 47014, Italy
Milan , 20122, Italy
Pavia , 27100, Italy
Reggio Emilia , 42123, Italy
Amsterdam , 1105 , Netherlands
Groningen , 9713, Netherlands
Leiden , 2333 , Netherlands
Maastricht , 6229 , Netherlands
Rotterdam , , Netherlands
Utrecht , 3584, Netherlands
Oslo , 310, Norway
Barcelona , 08908, Spain
Barcelona , 8035, Spain
Madrid , 28040, Spain
Madrid , 28046, Spain
Salamanca , 37007, Spain
Borås , , Sweden
Göteborg , 413 4, Sweden
Lund , , Sweden
Solna , , Sweden
Umeå , , Sweden
Uppsala , , Sweden
London , NW1 2, United Kingdom
Manchester , , United Kingdom
Newcastle Upon Tyne , NE7 7, United Kingdom
Plymouth , PL6 8, United Kingdom
How clear is this clinincal trial information?