NL-OMON52475招募中不适用
A Phase 1 Study of MK-5890 as Monotherapy and in Combination with Pembrolizumab in Participants with Advanced Solid Tumors - MK5890-001
Merck Sharp & Dohme (MSD)0 个研究点目标入组 51 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 51
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. a) Dose Escalation/Confirmation Phase (Arms 1 and 2): Have a histologically
- •or cytologically confirmed advanced/metastatic solid tumor by pathology report
- •and have received or been intolerant to all treatment known to confer clinical
- •b) Dose Escalation/Confirmation Phase (Arm 3): Have a histologically or
- •cytologically confirmed diagnosis of stage IV non-squamous NSCLC.
- •c) Dose Expansion Phase (Arm 2a): Have a diagnosis of TNBC. Participants must
- •have received or been intolerant to not more than 2 lines of therapy for
- •metastatic disease known to confer clinical benefit. Prior therapy should have
- •included anthracycline and/or taxane for early-stage or metastatic disease.
- •Participants must have lactate dehydrogenase (LDH) <=2 x ULN at screening.
- •Enrollment will be capped at a maximum of 7-10 participants who are PD-1/PD-L1
- •inhibitor treatment-refractory.
- •d) Dose Expansion Phase (Arm 1a, 2b, and 2c): Have a diagnosis of endometrial
- •cancer. Participants must have received or been intolerant to no more than 2
- •prior lines of treatment known to confer clinical benefit. Prior therapy should
- •have included platinum-containing regimens for early-stage or metastatic
- •disease. Enrollment will be capped at a maximum of 5-7 participants per
- •treatment arm who are PD-1/PD-L1 inhibitor treatment-refractory.
- •e) Dose Expansion Phase (Arm 4): Have TNBC with tumor PD-L1 CPS<10, that is
- •either locally recurrent, inoperable, not previously treated with chemotherapy
- •and which cannot be treated with curative intent or metastatic disease not
- •previously treated with chemotherapy.
- •2. Have measureable disease by RECIST 1.1. as assessed by the local site
- •investigator/radiologist. Target lesions situated in a previously irradiated
- •area are considered measurable if progression has been demonstrated in such
- •3. Have adequate organ function as defined in the protocol. Specimens must be
- •collected within 7 days before the first dose of study treatment.
- •4. Be male or non-pregnant and non-breast feeding female, >18 years of age on
- •the day of signing informed consent.
- •5. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •6. A male participant must agree to use contraception during the treatment
- •period and for at least 120 days after the last dose of MK-5890 or
- •pembrolizumab OR 180 days after the last dose of chemotherapeutic agents and
- •refrain from donating sperm during this period.
- •7. A female participant is eligible to participate if she is not pregnant , not
- •breastfeeding, and at least one of the following conditions applies:
- •a.) She is not a woman of childbearing potential (WOCBP)
- •b.) She is a WOCBP who agrees to follow the contraceptive guidance during the
- •treatment period and for at least 120 days after the last dose of MK-5890 or
- •pembrolizumab OR 180 days after the last dose of chemotherapeutic agents.
- •8. The participant (or legally acceptable representative if applicable)
- •provides documented informed consent/assent for the study. The participant may
- •also provide consent/assent for Future Biomedical Research, however he/she may
- •participate in the main study without participating in Future Biomedical
- •9. Submit an evaluable baseline tumor sample for analysis (either a newly
- •obtained or archival tumor sample). Formalin-fixed, p
排除标准
- •1. Has a history of a second malignancy, unless potentially curative treatment
- •has been completed with no evidence of malignancy for 2 years.
- •Note: The time requirement does not apply to the disease under study,
- •participants who underwent successful definitive resection of basal cell
- •carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder
- •cancer, in situ cervical cancer, or other in situ cancers.
- •2. Has clinically active central nervous system (CNS) metastases and/or
- •carcinomatous meningitis. Participants with previously-treated brain or
- •meningeal metastases may participate and be eligible for treatment provided
- •they are stable and asymptomatic (without evidence of progression by magnetic
- •resonance imaging [MRI] scan of the brain separated by at least 4 weeks after
- •treatment), have no evidence of new or enlarging brain metastases, are
- •evaluated within 4 weeks before the start of study treatment, and are off
- •immunosuppressive doses of systemic steroids for at least 2 weeks prior to
- •enrollment.
- •3. Has had a severe hypersensitivity reaction to treatment with a mAb and/or
- •other components of the study treatment.
- •4. Has an active infection requiring systemic treatment.
- •5. Has a history of interstitial lung disease.
- •6. Has a history of (noninfectious) pneumonitis that required steroids or
- •current pneumonitis.
- •7. Has symptomatic ascites or pleural effusion. Participants who are clinically
- •stable after treatment of these conditions (including therapeutic
- •thoracocentesis or paracentesis) will not be excluded from participation in
- •this study.
- •8. Has previously had a stem cell or bone marrow transplant.
- •9. Has previously had a solid organ transplant.
- •10. Has an active autoimmune disease that has required systemic treatment in
- •the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or
- •immunosuppressive drugs) except vitiligo or resolved childhood asthma/atopy.
- •Replacement therapy, such as thyroxine, insulin, or physiologic corticosteroid
- •replacement therapy for adrenal or pituitary insufficiency, is not considered a
- •form of systemic treatment and is allowed. Use of nonsystemic steroids is
- •11. Has known human immunodeficiency virus ([HIV]; HIV 1 or 2 antibodies)
- •and/or active and acute Hepatitis B or C infections (eg, positive for HBsAg/HBV
- •DNA or HCV RNA).
- •12. Has a history or current evidence of any condition, therapy, or laboratory
- •abnormality that might confound the results of the study, interfere with the
- •participant*s participation for the full duration of the study, make
- •administration of the study treatments hazardous, or make it difficult to
- •monitor adverse effects such that it is not in the best interest of the
- •participant to participate, in the opinion of the treating investigator.
- •13. Has not fully recovered from any effects of major surgery without
- •significant detectable infection. Surgeries that required general anesthesia
- •must be completed at least 2 weeks before the start of study treatment.
- •Surgeries that required regional/epidural anesthesia must be completed at least
- •72 hours before the first dose of study treatment and participants should be
- •14. Has known psychiatric or substance abuse disorders that would interfere
- •with the participant*s ability to cooperate with the requirements
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