EUCTR2021-003397-32-IT进行中（未招募）1 期
A Phase 2 Open-label Clinical Study to Evaluate the Efficacy and Safety of Zilovertamab Vedotin (MK-2140) in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma - A Single-Cohort Study of MK-2140 in rrDLBC
MERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.0 个研究点目标入组 100 人开始时间: 2021年10月7日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Has relapsed or refractory DLBCL and have failed at least 2 lines of prior therapy, and have failed auto-SCT or are auto-SCT ineligible. Must have received prior rituximab/anti-CD20 monoclonal antibody.
- •a Relapsed disease: progression after achieving an overall response of PR or CR in response to the most recent therapy.
- •b Refractory disease: failure to achieve CR or PR to the most recent therapy.
- •c Ineligibility for auto-SCT: Is >65 years old
- •Has organ dysfunction or comorbidities precluding the use of HDT or auto-SCT
- •Has not responded to salvage therapy
- •Has refused auto-SCT
- •Has an inability to successfully collect peripheral blood stem cells. Histologically confirmed diagnosis of DLBCL, according to the WHO classification of neoplasms of the hematopoietic and lymphoid tissues.
- •3. a. Has radiographically measurable DLBCL per the Lugano Response Criteria, with at least 1 nodal lesion (non-irradiated) that is >1.5 cm in the long axis, regardless of length of the short axis, AND/OR extranodal lesion of >=1.0 cm in the long and short axis.
- •b. Has PET positive disease verified by BICR at Screening defined as 4-5 on a 5-point scale.
- •4. Life expectancy of at least 3 months, in the opinion of the investigator.
- •5. Is male or female, from 18 years of age inclusive, at the time of signing the informed consent.
- •6. Male participants are eligible to participate if they agree to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention. The length of time required to continue contraception for each study intervention is:
- •Zilovertamab vedotin: 110 days
- •Refrain from donating sperm
- •PLUS either:
- •Be abstinent from heterosexual intercourse as their preferred and usual lifestyle and agree to remain abstinent
- •Must agree to use contraception unless confirmed to be azoospermic as detailed below:
- •- Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a WOCBP who is not currently pregnant.
- •Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions is more stringent than the requirements above, the local label requirements are to be followed.
- •7. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
- •Is not a WOCBP
- •Is a WOCBP and:
- •- Uses a contraceptive method that is highly effective, with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis), during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period. The length of time required to continue contraception for each study intervention is as follows:
- •Zilovertamab Vedotin 50 days
- •The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention.
- •-Contraceptive use by women should be consistent with local regulations regarding the me
排除标准
- •1. Has received a diagnosis of PMBCL.
- •2. Has undergone solid organ transplant at any time.
- •3. Has clinically significant (ie, active) cardiovascular disease: cerebral vascular accident/stroke (<6 months prior to enrollment), myocardial infarction (<6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class >= II), serious cardiac arrhythmia requiring medication, arterial
- •thromboembolism, cerebrovascular thromboembolism (<6 months prior to enrollment), uncontrolled Grade >=3 hypertension (diastolic blood pressure >=100 mm Hg or systolic blood pressure >=160 mm Hg) despite antihypertensive therapy; or significant conduction system ECG abnormalities, including second-degree AV block type II, third-degree AV block, or Grade >=2 bradycardia, or serious cardiac arrhythmia requiring medication.
- •4. Known history of liver cirrhosis.
- •5. Has pericardial effusion or clinically significant pleural effusion.
- •6. Has baseline peripheral neuropathy > Grade 1.
- •7. Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years.
- •8. Has a demyelinating form of Charcot-Marie-Tooth disease.
- •9. Has received prior therapy with a ROR1-directed therapy.
- •10. Has contraindication to any of the study intervention components.
- •11. Transformed DLBCL from indolent lymphoma.
- •12. In participants with prior allo-SCT, acute GVHD or ongoing evidence of chronic GVHD manifesting as Grade >=2 serum bilirubin, Grade >=3 skin involvement, or Grade >=3 diarrhea or requiring treatment for their GVHD.
- •13. Has received prior systemic anticancer therapy, including investigational agents within 4 weeks prior to the first dose of study intervention.
- •14. Has received prior radiotherapy within 4 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (<=2 weeks of radiotherapy) to non-CNS disease.
- •15. Has ongoing corticosteroid therapy (exceeding 30 mg daily of prednisone equivalent). Prednisone equivalent dosing must have been stable for at least 4 weeks prior to C1D1.
- •16. Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
- •For more exclusion criteria please see the protocol.
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