NL-OMON55940招募中2 期
A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants With RCC (KEYMAKER-U03): Substudy 03B - MK3475-03B
Merck Sharp & Dohme (MSD)0 个研究点目标入组 9 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 9
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
- •# The participant has provided documented informed consent for this study.
- •# Male or female from 18 years to 120 years at the time of signing the informed
- •consent form.
- •# Histologically confirmed diagnosis of locally advanced/metastatic ccRCC (with
- •or without sarcomatoid features).
- •# Disease progression on or after systemic treatment for locally advanced or
- •metastatic RCC with a PD-(L)1 checkpoint inhibitor (in sequence or in
- •combination with a VEGF-TKI). Criteria for PD-(L)1 checkpoint inhibitor
- •treatment progression are per protocol.
- •# Disease progression on or after systemic treatment for locally advanced or
- •metastatic RCC with a VEGF-TKI (in sequence or in combination with a PD-[L]1
- •checkpoint inhibitor). Criterion for VEGF-TKI treatment progression is per
- •# Measurable disease by RECIST 1.1 (assessed by a Blinded Independent Central
- •# Karnofsky Performance Status >=70% (within 10 days before
- •randomization/allocation).
- •# Able to swallow oral medication.
- •# Presence of an evaluable archival or newly obtained tumor tissue sample for
- •central analysis.
- •# Adequate organ function (within 10 days before the start of study
- •intervention).
- •# If on bone resorptive therapy, this must be initiated at least 2 weeks before
- •randomization/allocation.
- •# Toxic effects of prior therapy are resolved to <= grade 1 (exceptions per
- •protocol) and for systemic steroid therapy due to an irAE the dose should not
- •exceed 10 mg daily of prednisone (or equivalent).
- •# Adequately controlled blood pressure with or without antihypertensive
- •medications.
- •# A male participant must agree to use contraception as detailed in the
- •# A female participant is eligible to participate if not pregnant or
- •breastfeeding, agrees to follow the contraceptive guidance as detailed in the
- •protocol, or is not of child-bearing potential.
排除标准
- •# Prior treatment with pembrolizumab plus lenvatinib in combination.
- •# Prior treatment with belzutifan or another HIF-2a inhibitor.
- •# Treated with more than 4 previous systemic anticancer treatment regimens.
- •# Previously randomized/allocated to study intervention in any substudy of
- •protocol MK3475-U03.
- •# Received an investigational product or used an investigational device within
- •4 weeks before the first dose of study intervention.
- •# Prior radiotherapy within 2 weeks before the first dose of study intervention
- •or radiation-related toxicities requiring corticosteroids (exceptions per
- •# Live or live attenuated vaccine within 30 days before the first dose of study
- •intervention.
- •# Allogeneic tissue/solid organ transplant.
- •# Clinically significant cardiovascular disease within 12 months before first
- •dose of study intervention (details per protocol).
- •# Prolongation of QTcF interval to >480 ms.
- •# LVEF below the institutional normal range as determined by MUGA or ECHO.
- •# Major surgery within 3 weeks before first dose of study intervention.
- •# Urine protein >=1 g/24 hours.
- •# History of interstitial lung disease, history of (noninfectious) pneumonitis
- •that required steroids, or current pneumonitis.
- •# Symptomatic pleural effusion (details per protocol).
- •# History of inflammatory bowel disease.
- •# Preexisting grade >=3 GI or non-GI fistula, or malabsorption due to prior GI
- •surgery or GI disease.
- •# Active hemoptysis within 3 weeks prior to the first dose of study
- •intervention.
- •# Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy
- •(or any other form of immunosuppressive therapy) within 7 days before the first
- •dose of study intervention.
- •# Known additional malignancy that is progressing or required active treatment
- •within the past 3 years (exceptions per protocol).
- •# Known active CNS metastases and/or carcinomatous meningitis (exceptions per
- •# Radiographic evidence of encasement or invasion of a major blood vessel, or
- •of intratumoral cavitation.
- •# History of (severe) hypersensitivity reaction to any of the investigational
- •products included in this study.
- •# Active autoimmune disease that required systemic treatment in the past 2
- •years (details and exceptions per protocol).
- •# Active infection requiring systemic therapy.
- •# Known history of HIV and/or hepatitis B infection, or known active hepatitis
- •C infection.
- •# Pulse oximeter reading <92% at rest, or requiring intermittent or chronic
- •supplemental oxygen.
- •# Known psychiatric or substance abuse disorder that would interfere with the
- •participant*s ability to cooperate with the requirements of the study.
- •# 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 in
- •the best interest of the participant to participate, in the opinion of the
- •treating investigator.
研究者
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