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).

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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 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.

View Eligibility Criteria

Eligibility Criteria

Key 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

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

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.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

396

Study ID:

NCT04663347

Recruitment Status:

Recruiting

Sponsor:

Genmab

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There are 50 Locations for this study

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University of Alabama at Birmingham
Birmingham Alabama, 35294, United States
Cedars-Sinai Medical Center
Los Angeles California, 90048, United States
David Geffen School of Medicine at UCLA
Los Angeles California, 90095, United States
University of California San Francisco
San Francisco California, 94143, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 84109, United States
John Theurer Cancer Center at Hackensack UMC
Hackensack New Jersey, 07601, United States
Mount Sinai
New York New York, 10029, United States
Memorial Sloan Kettering CC
New York New York, 10065, United States
Levine Cancer Center
Charlotte North Carolina, 28204, United States
UMPC Hillman Cancer Center Cancer Pavillion
Pittsburgh Pennsylvania, 15232, United States
UT Southwestern Medical Center
Dallas Texas, 75390, United States
Monash Medical Centre
Clayton Victoria, 3084, Australia
Austin Health
Heidelberg , VIC 3, Australia
Linear Clinical Research Limited
Nedlands , 6009, Australia
AZ Sint-Jan
Brugge , 8000, Belgium
Universitair Ziekenhuis Gent
Gent , 9000, Belgium
CHU UCL Namur Site Godinne
Yvoir , 5530, Belgium
Fakultni nemocnice Hradec Kralove
Hradec Králové , , Czechia
Fakultni nemocnice Ostrava
Ostrava - Poruba , , Czechia
Fakultni nemocnice v Motole
Prague , 15006, Czechia
Vseobecna Fakultni Nemocnice
Praha 2 , , Czechia
Århus Hospital
Arhus , , Denmark
Rigshospitalet
Copenhagen , 2100, Denmark
Odense University Hospital
Odense , , Denmark
Vejle Sygehus
Vejle , , Denmark
Tampere University Hospital
Helsinki , 33520, Finland
Kuopio University Hospital
Kuopio , 70210, Finland
HUS Cancer Center
Lahti , 15850, Finland
Institut Bergonié
Bordeaux , 33076, France
CHU Dijon - Hopital du Bocage
Dijon , 21000, France
Hopital Claude Huriez - CHRU Lille
Lille , 59037, France
Hôpital de la Timone
Marseille , 13005, France
Hôpital Saint-Louis
Paris , 75475, France
Centre Hospitalier Lyon Sud
Pierre-Bénite , 69495, France
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
Bergamo , 24127, Italy
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
Bologna , , Italy
Fondazione del Piemonte per l Oncologia Istituto di Candiolo IRCCS
Candiolo , 10060, Italy
Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori
Meldola , 47014, Italy
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milan , 20122, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia , 27100, Italy
Arcispedale S. Maria Nuova Azienda Ospedaliera di Reggio Emilia
Reggio Emilia , 42123, Italy
Amsterdam UMC, Locatie VUMC
Amsterdam , 1105 , Netherlands
Universitair Medisch Centrum Groningen (UMCG)
Groningen , 9713, Netherlands
Leids Universitair Medisch Centrum
Leiden , 2333 , Netherlands
Maastricht University Medical Center
Maastricht , 6229 , Netherlands
Erasmus Medisch Centrum
Rotterdam , , Netherlands
UMC Utrecht
Utrecht , 3584, Netherlands
Oslo Universitetssykehus HF, Radiumhospitalet
Oslo , 310, Norway
ICO l Hospitalet
Barcelona , 08908, Spain
Hospital Universitari Vall d'Hebron
Barcelona , 8035, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid , 28040, Spain
Hospital Universitario La Paz
Madrid , 28046, Spain
Hospital Universitario de Salamanca
Salamanca , 37007, Spain
Södra Älvsborgs Sjukhus
Borås , , Sweden
Sahlgrenska Sjukhuset
Göteborg , 413 4, Sweden
Skånes Universitetssjukhus
Lund , , Sweden
Karolinska Universitetssjukhuset
Solna , , Sweden
Norrlands Universitetssjukhus
Umeå , , Sweden
Akademiska Sjukhuset
Uppsala , , Sweden
University College London Hospitals
London , NW1 2, United Kingdom
The Christie NHS Foundation Trust
Manchester , , United Kingdom
Freeman Hospital
Newcastle Upon Tyne , NE7 7, United Kingdom
Derriford Hospital
Plymouth , PL6 8, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

396

Study ID:

NCT04663347

Recruitment Status:

Recruiting

Sponsor:


Genmab

How clear is this clinincal trial information?

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