A Randomized, Open-Label, Multicenter, Global, Phase 2 Trial to Evaluate the Efficacy and Safety of Epcoritamab (GEN3013; DuoBody®-CD3×CD20) as Monotherapy or in Combination with Lenalidomide as First-Line Therapy for Anthracycline-Ineligible Subjects with Diffuse Large B-Cell Lymphoma

Genmab A/S47 个研究点分布在 8 个国家目标入组 102 人2024年1月18日

概览

阶段: 2 期
干预措施: 未指定
疾病 / 适应症: 未指定
发起方: Genmab A/S
入组人数: 102
试验地点: 47
主要终点: Complete response (CR) rate determined by Lugano criteria
状态: 招募中
最后更新: 11个月前

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

Evaluate the clinical efficacy of epcoritamab monotherapy or epcoritamab and lenalidomide

注册库

euclinicaltrials.eu

开始日期

2024年1月18日

结束日期

待定

最后更新

11个月前

研究者

发起方

Genmab A/S

责任方

Principal Investigator

主要研究者

Information

Scientific

Genmab A/S

入排标准

入选标准

•Must have newly diagnosed CD20+ large cell lymphoma.
•Is ineligible for anthracycline-based therapy/cytotoxic chemotherapy due to: oBeing age ≥80 years; AND/OR oBeing age ≥75 years and having important comorbid condition(s), which are likely to have a negative impact on tolerability of anthracycline-based therapy/cytotoxic chemotherapy, Have Immune Effector Cell-Associated Encephalopathy (ICE) score of at least 8 out of
•Have Ann Arbor Stage II-IV disease.
•Have ECOG PS of 0, 1, or 2; (ECOG PS of 3 may be considered if impairment is attributed to current lymphoma/DLBCL and if pre-phase treatment during the screening phase results in an improvement of ECOG PS to ≤2 prior to enrollment.)
•Have measurable disease as per Lugano criteria.
•Have acceptable organ function based on baseline bloodwork.
•Must have fresh (preferred) or archival biopsy material at screening.

排除标准

•Has known active, clinically significant bacterial, viral, fungal, mycobacterial, parasitic, or other infection at trial enrollment, including COVID-19 infection.
•Has suspected active or inadequately treated latent tuberculosis.
•Has a known history of seropositivity for HIV. Note: HIV testing is required at screening only if required per local health authorities or institutional standards.
•Has severe cardiovascular disease (other than those eligibility criteria that preclude the subject from receiving anthracycline-based therapy/cytotoxic chemotherapy).
•Has been exposed to/received any of the following prior therapies, treatments, or procedures within the specified timeframes: oMajor surgery within 4 weeks prior to the first dose of epcoritamab; oNon-investigational antineoplastic agents or any investigational drug within 4 weeks or 5 half-lives, whichever is shorter, prior to the first dose of epcoritamab; oAutologous hematopoietic stem cell transplantation (HSCT), CAR-T, allogeneic stem cell transplantation, or solid organ transplantation; oLive, attenuated vaccines within 30 days prior to initiation of epcoritamab; oInvestigational vaccines within 28 days before the planned first dose of epcoritamab (ie, experimental and/or non-authorized SARS-CoV-2 vaccinations and therapies are not allowed); oInvasive investigational medical device use within 28 days before the planned first dose of epcoritamab.
•Has primary central nervous system (CNS) tumor or known CNS involvement or intracranial involvement as confirmed by mandatory brain magnetic resonance imaging/computed tomography (MRI/CT) scan at screening and, if clinically indicated, by lumbar puncture.
•Has a seizure disorder requiring anti-epileptic therapy or experienced a seizure within 6 months of signing an informed consent form.
•Has known past or current malignancy other than inclusion diagnosis, with exceptions as stated in protocol.
•Has known or suspected allergies, hypersensitivity, or intolerance to either of the trial treatments or has known or suspected contraindication to the use of all locally available anti-cytokine therapies per local guidelines for management of cytokine release syndrome (CRS).
•Has active hepatitis B virus (HBV) (DNA polymerase chain reaction [PCR]-positive) or hepatitis C virus (HCV) (RNA PCR-positive) infection, current alcohol abuse, or cirrhosis.

结局指标

主要结局

Complete response (CR) rate determined by Lugano criteria

次要结局

Duration of response (DOR) determined by Lugano criteria
Duration of complete response (DOCR) determined by Lugano criteria
Time to response (TTR) determined by Lugano criteria
Overall response rate (ORR) determined by Lugano criteria
Progression-free survival (PFS) determined by Lugano criteria
Time to next (anti-lymphoma) therapy (TTNT).
Rate and duration of minimal residual disease (MRD) negative status
Overall survival (OS)
Incidence of dose-limiting toxicities (DLTs)
Incidence and severity of adverse events (AEs)
Incidence and severity of changes in laboratory values
Incidence of antidrug antibodies (ADAs) to epcoritamab
PK parameters (clearance, volume of distribution, area under-the- concentration-time curve [AUC0-last and AUC0-∞], maximum concentration [Cmax], time of Cmax [Tmax], predose values, and halflife [t½])
Changes in lymphoma symptoms as measured by the Functional Assessment of Cancer Therapy – Lymphoma (FACT-Lym)