NL-OMON56267已完成2 期
Phase 2 Study of MK-6482 in Participants With Advanced Renal Cell Carcinoma - MK6482-013
Merck Sharp & Dohme (MSD)0 个研究点目标入组 19 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
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. Must have a histologically confirmed diagnosis of locally
- •advanced/metastatic RCC with clear cell component (with or without sarcomatoid
- •features) 2. Has measurable disease per RECIST 1.1 as assessed by BICR. 3.
- •Submit an archival tumor tissue sample or newly obtained core or excisional
- •biopsy of a tumor lesion not previously irradiated. FFPE tissue blocks are
- •preferred to slides. Newly obtained biopsies are preferred to archived tissue.
- •4. Has experienced disease progression on or after having received first-line
- •systemic treatment for locally advanced or metastatic RCC with prior
- •anti-PD-1/L1 + anti-CTLA4 combination or anti-PD-1/L1 + VEGF-targeted TKI
- •combination. - PD-1/L1 checkpoint inhibitor-based combination regimens (with
- •either VEGFtargeted TKI or anti-CTLA-4) treatment progression is defined by
- •meeting ALL of the following criteria: o Has received at least 2 doses of an
- •anti-PD-1/L1 mAb. o Has demonstrated radiographic disease progression during or
- •after an anti-PD- 1/L1 mAb as assessed by investigator. - If the participant
- •has received >1 prior regimen, there must have been demonstrated radiographic
- •disease progression after the most recently received regimen. 5. Has received
- •no more than 3 prior systemic regimens for locally advanced or metastatic RCC.
- •6. Is male or female, who is at least 18 years of age at the time of signing
- •the informed consent. 7. Has a KPS score of at least 70% [Karnofsky, D. A., et
- •al 1948] assessed within 10 days prior to the first dose of study intervention.
- •8. Male participants are eligible to participate if they agree to the following
- •during the intervention period and for at least 5 days after the last dose of
- •study intervention: • Be abstinent from heterosexual intercourse as their
- •preferred and usual lifestyle (abstinent on a long term and persistent basis)
- •and agree to remain abstinent OR • Must agree to use contraception unless
- •confirmed to be azoospermic (vasectomized or secondary to medical cause) 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. • Male participants must also agree to use male condom
- •when engaging in any activity that allows for passage of ejaculate to another
- •person of any sex. • Contraceptive use by men should be consistent with local
- •regulations regarding the methods of contraception for those participating in
- •clinical studies. 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 OR • Is a WOCBP and using a contraceptive method that
- •is highly effective (with a failure rate of <1% per year), 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 30 days after the last dose of study
- •intervention. The investigator should evaluate the potential for contraceptive
- •method failure (ie, noncompliance, recently initiated) in relationship to the
- •first dose of study intervention. • A WOCBP must have a negative highly
- •sensitive pregnancy test (urine or serum as required by local regulations)
- •within 24 hours before the
排除标准
- •1. A WOCBP who has a positive urine pregnancy test within 24 hours prior to
- •randomization (see Appendix 5). If the urine test is positive or cannot be
- •confirmed as negative, a serum pregnancy test will be required. 2. Has any of
- •the following: - Hypoxia as defined by a pulse oximeter reading <92% at rest,
- •or - Requires intermittent supplemental oxygen, or - Requires chronic
- •supplemental oxygen. 3. Has a known additional malignancy that is progressing
- •or has required active treatment within the past 3 years. 4. Has known CNS
- •metastases and/or carcinomatous meningitis. 5. Has clinically significant
- •cardiac disease, including unstable angina, acute myocardial infarction <=6
- •months from Day 1 of study drug administration, or New York Heart Association
- •Class III or IV congestive heart failure. Medically controlled arrhythmia
- •stable on medication is permitted. 6. Has moderate to severe hepatic impairment
- •(Child-Pugh B or C). 7. Received colony-stimulating factors (eg, G-CSF, GM-CSF
- •or recombinant EPO) <=28 days prior to the first dose of study intervention. 8.
- •Has a known psychiatric or substance abuse disorder that would interfere with
- •cooperation with the requirements of the study. 9. Is unable to swallow orally
- •administered medication or has a gastrointestinal disorder affecting absorption
- •(eg, gastrectomy, partial bowel obstruction, malabsorption). 10. Has known
- •hypersensitivity or allergy to the active pharmaceutical ingredient or any
- •component of the study intervention (MK-6482) formulations. 11. Has received
- •prior treatment with MK-6482 or another HIF-2a inhibitor. 12. Has received any
- •type of small molecule kinase inhibitor (including investigational kinase
- •inhibitor) <=2 weeks before randomization. 13. Has received any type of systemic
- •anticancer antibody (including investigational antibody) <=4 weeks before
- •randomization. 14. Has received prior radiotherapy <=2 weeks prior to first dose
- •of study intervention. Participants must have recovered from all
- •radiation-related toxicities and not require corticosteroids. A 1-week washout
- •is required for palliative radiation (<=2 weeks of radiotherapy) to non-CNS
- •disease. 15. Has had major surgery <=3 weeks prior to first dose of study
- •intervention. 16. Is currently receiving either strong (phenobarbital,
- •enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine,
- •nevirapine and St John*s Wort) or moderate (eg, bosentan, efavirenz, modafinil)
- •inducers of CYP3A4 that cannot be discontinued for the duration of the study.
- •17. Is currently participating in a study of an investigational agent or is
- •currently using an investigational device. 18. Has an active infection
- •requiring systemic therapy. 19. Has active TB. 20. Has a diagnosis of
- •immunodeficiency. 21. Has a known history of HIV infection. 22. Has a known
- •history of HBV (defined as HBsAg reactive) or known active HCV (defined as HCV
- •RNA [qualitative] is detected) infection. 23. 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, or is not the best interest of the participant to
- •participate, in the opinion of the treating investigator.
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