2023-504832-16-00招募中2 期
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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 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
研究概览
简要总结
Evaluate the clinical efficacy of epcoritamab monotherapy or epcoritamab and lenalidomide
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Stage 2
- 盲法
- None
入排标准
- 年龄范围
- 65 years 至 65+ years（65+ Years）
- 接受健康志愿者
- 否
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.
- •Has active cytomegalovirus (CMV) infection (DNA PCR-positive) requiring treatment.
结局指标
主要结局
Complete response (CR) rate determined by Lugano criteria
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)
研究者
Information
Scientific
Genmab A/S
研究点 (47)
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