NL-OMON53900尚未招募2 期
A Phase 2 Study to Evaluate the Efficacy and Safety of Belzutifan (MK-6482, formerly PT2977) Monotherapy in Participants with Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), or von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Advanced Solid Tumors With HIF-2a related Genetic Alterations - MK6482-015
Merck Sharp & Dohme (MSD)0 个研究点目标入组 5 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 5
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
- 12 至 99（—）
入选标准
- •The below mentioned inclusion criteria are the most important ones. A complete
- •list of specific inlcusion criteria can be found in the protocol.
- •Cohort A1: (PPGL)
- •1. Has documented histopathological diagnosis (local report) of
- •pheochromocytoma or paraganglioma.
- •2. Has locally advanced or metastatic disease that is not amenable to surgery
- •or curative intent treatment.
- •3. Adequately controlled blood pressure defined as BP <=150/90 mm Hg (<=135/85 mm
- •Hg for adolescents) and with no change in antihypertensive medications (for
- •participants with concomitant hypertension) for at least 2 weeks prior to start
- •of study treatment.
- •Cohort A2: (pNET)
- •4. Has documented histopathological or cytopathological diagnosis (local
- •report) of well-differentiated, low or intermediate grade (G1 or G2 pNET per
- •2017 WHO classification and grading) pNET.
- •5. Has locally advanced disease or metastatic disease that is:
- •a. Not amenable for surgery, radiation, locoregional therapies or combination
- •modality of such treatments with curative intent.
- •b. Experienced disease progression on or after at least 1 line of prior
- •systemic therapy that includes an approved targeted agent such as everolimus
- •(mTOR inhibitor) or sunitinib (anti-VEGF targeted agent). Participants who have
- •received >3 prior systemic therapies will be capped to <=20% of the cohort.
- •6. Has disease progression within the past 12 months from Screening.
- •7. Has measurable disease per RECIST 1.1 by CT or MRI as assessed by local site
- •investigator/radiology assessment and verified by BICR.
- •a. Irradiated lesions or lesions treated with locoregional therapies should not
- •be used as target lesions unless they clearly demonstrate growth since
- •completion of radiation.
- •b. Metastatic lesions situated in the brain are not considered measurable and
- •should be considered nontarget lesions. (This criterion does not apply to
- •Cohort B1 participants)
- •c. Only lesions of the primary indication for the cohort may be evaluated for
- •measurability; other neoplastic lesions will be documented by the investigator
- •and this information provided to the independent reviewers to ensure that such
- •lesions are not included in the RECIST assessment. See also Exclusion Criterion
- •2. For Cohort B1 tumor specific requirements refer inclusion criteria #16 and
- •8. Is male or female, 12 years of age inclusive (>=40 kg for adolescents [12-17
- •years of age]), at the time of providing the informed consent. Only adult
- •participants (>=18 years of age) are eligible to participate for Cohort B1.
- •9. Male participants are eligible to participate if they agree to the following
- •during the intervention period and for at least 7 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
- •Must agree to use contraception unless confirmed to be azoospermic
- •(vasectomized or secondary to medical cause [Appendix 5]) 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. Note: Men with a pregnant or breastfeeding partner must agree to
- •remain abstinent from penile-vaginal intercourse or
排除标准
- •The below mentioned exclusion criteria are the most important ones. A complete
- •list of specific inlcusion criteria can be found in the protocol.
- •1. Is unable to swallow orally administered medication or has a disorder that
- •might affect the absorption of belzutifan.
- •2. Has a history of a second malignancy, unless potentially curative treatment
- •has been completed with no evidence of malignancy for 2 years with some
- •exceptions, refer to the protocol
- •3. Has known CNS metastases and/or carcinomatous meningitis.
- •4. Has any of the following:
- •o A pulse oximeter reading <92% at rest, or
- •o Requires intermittent supplemental oxygen, or
- •o Requires chronic supplemental oxygen.
- •5. Has clinically significant cardiac disease, including unstable angina, acute
- •myocardial infarction, or arterial bypass (CABG) or PTCA <=6 months from Day 1
- •of study drug administration, or New York Heart Association Class III or IV
- •congestive heart failure. Concurrent uncontrolled hypertension defined as
- •BP>150/90 mm Hg despite optimal antihypertensive medications within 2 weeks
- •prior to the first dose of study treatment.
- •6. Has a known psychiatric or substance abuse disorder that would interfere
- •with cooperation with the requirements of the study.
- •7. Has had major surgery <=4 weeks prior to first dose of study intervention.
- •Note: Adequate wound healing after major surgery must be assessed clinically,
- •independent of time elapsed for eligibility.
- •8. Has received prior treatment (except somatostatin analogs for pNET
- •participants) with chemotherapy, targeted therapy biologics, or other
- •investigational therapy within the past 4 weeks of first dose of study
- •intervention.
- •Note: Refer to exclusion criterion#2g for Cohort B1 participants.
- •9. Has received prior locoregional therapies or radiation within the past 4
- •weeks of first dose of study intervention.
- •10. Has received prior treatment with PRRT/radionuclide therapy (such as
- •177Lu-Dotatate) or other radiopharmaceutical therapy within the past 12 weeks
- •from Screening for participants with pNET.
- •Note: Refer to exclusion criterion#2g for Cohort B1 participants.
- •11. Has received MIBG therapy or other radiopharmaceutical therapy within the
- •past 12 weeks from Screening for participants with PPGL.
- •Note: Refer to exclusion criterion#2g for Cohort B1 participants.
- •12. Has received prior treatment with any HIF-2a inhibitor (including
- •belzutifan).
- •13. Has a known hypersensitivity to the study treatment and/or any of its
- •excipients.
- •14. Has toxicities from prior locoregional or systemic or any other therapies
- •that is not recovered to CTCAE <=Grade 1 (with the exception of alopecia).
- •15. Has received colony-stimulating factors (eg, G-CSF, GM-CSF, or recombinant
- •EPO) <=28 days prior to the first dose of study intervention.
- •16. Is currently receiving strong) inhibitors of CYP3A4 that cannot be
- •discontinued for the duration of the study. Note: Topical preparations are
- •acceptable.
- •17. Is currently receiving either strong or moderate inducers of CYP3A4 that
- •cannot be discontinued for the duration of the study.
- 另有 4 项未显示
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