EUCTR2020-001907-18-NL进行中（未招募）1 期
Phase 2 Study of MK-6482 in Participants With Advanced Renal Cell Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
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
- •A participant will be eligible for inclusion in the study if the participant:
- •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
- •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
- •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 first dose of study intervention.
- •If a urine test cannot be confirmed as negative (eg, an
排除标准
- •The participant must be excluded from the study if the participant:
- •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.
研究者
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