EUCTR2021-003313-18-PL进行中（未招募）1 期
A Phase 2/3 Multicenter, Open-label, Randomized, Active-Control Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (waveLINE-003). - A Multi-Cohort Study of MK-2140 in Combination With Standard of Care in DLBC
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 420
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
- •Type of Participant and Disease Characteristics
- •1.Has a histologically confirmed diagnosis of DLBCL, according to the WHO classification of neoplasms of the hematopoietic and lymphoid tissues
- •2.Has radiographically measurable DLBCL per the Lugano response criteria with at least 1 nodal lesion (nonirradiated) 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.
- •3.Has relapsed or refractory DLBCL and is ineligible for or have failed ASCT and have failed at least 1 line of prior therapy. Participants with DLBCL who have failed at least 2 lines of prior therapy will be capped at 50%
- •4.Has post-CAR-T cell therapy failure or is ineligible for CAR-T cell therapy
- •5.Has relapsed or refractory DLBCL and is ineligible for or have failed ASCT and have failed at least 2 lines of prior therapy
- •6.Has post-CAR-T therapy failure or is ineligible for CAR-T cell therapy
- •Demographics
- •7.Is male or female, from 18 years of age inclusive, at the time of signing the informed consent.
- •8.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 as follows:
- •-Zilovertamab vedotin 110 days
- •-Chemotherapy 90 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.
- •Female Participants
- •9.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 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 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
- •?Chemotherapy: 180 days
- •The investigator should evaluate the potential for contraceptive method failure in relationship to the first dose of study intervention. Contraceptive use by women 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.
- •-Has a negative highly sensitive pregnancy test within 24 hours for urine and 72 hours for serum before the first dose of study intervention.
- •-Abstains from breastfeeding during the study intervention period and for at lea
排除标准
- •Medical Conditions
- •1. Has history of transformation of indolent disease to DLBCL
- •2. Has received solid organ transplant at any time
- •3. Has received a diagnosis of PMBCL
- •4. 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), or serious cardiac arrhythmia requiring medication
- •5. Has ongoing GVHD of any grade, or is receiving treatment for their GVHD
- •6. Has pericardial effusion or clinically significant pleural effusion
- •7. Has ongoing Grade >1 peripheral neuropathy
- •8. Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years
- •9. Has a demyelinating form of Charcot-Marie-Tooth disease
- •Prior/Concomitant Therapy
- •10. Has received prior therapy with a ROR1-directed therapy. Prior exposure to MMAEcontaining drugs (eg, polatuzumab vedotin) is allowed
- •11. Has contraindication to any of the study intervention components
- •12. Has received prior systemic anticancer therapy, including investigational agents within 4 weeks prior to the first dose of study intervention
- •13. 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
- •14. 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
- •15. Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed
- •16. Has received a strong inhibitor or inducer of CYP3A4 (including itraconazole, ketoconazole, posaconazole, or voriconazole) within 7 days prior to C1D1 or expected requirement for chronic use of a strong CYP3A4 inhibitor or inducer during Cycle 1 of study therapy
- •Prior/Concurrent Clinical Study Experience
- •17. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks before the first dose of study intervention
- •Diagnostic Assessments
- •18. Has known active CNS lymphoma involvement or active CNS involvement by lymphoma. Participants with prior CNS involvement are eligible if their CNS disease is in radiographic, cytological (for cerebrospinal fluid disease), and clinical remission
- •19. Has an active infection requiring systemic therapy
- •20. Has a known history of HIV infection. No HIV testing is required unless mandated by local health authority
- •21. Has a known active hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection
- •22. Has a history or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator
- •23. Has a known psychiatric or substance abuse disorder that would interfere with the participant’s ability to cooperate with the requirements of the study
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