NL-OMON50266已完成2 期
An Open-label Phase 1b/2 Study of Binimetinib Administered in Combination with Nivolumab or Nivolumab Plus Ipilimumab in Patients with Previously Treated Microsatellite-stable (MSS) Metastatic Colorectal Cancer with RAS Mutation. - ARRAY-162-202
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 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
- •Prescreening Inclusion Criteria:, 1. Provide a signed and dated Prescreening
- •2. Male or female * 18 years of age at the time of signing the Screening
- •3. Measurable, histologically/cytologically confirmed mCRC per RECIST v1.1.
- •4. Have willingness and ability to participate in the study.
- •5. Able to provide a sufficient amount (tumor block or minimum of 6
- •slides) of representative tumor specimen (primary or metastatic,
- •archival or newly obtained) for central laboratory testing of RAS
- •mutation status and MSS.
- •a. If a fresh tissue sample is provided, a blood sample is required.
- •6. Have received no more than 2 prior lines of systematic therapy in the
- •metastatic setting (maintenance
- •therapy given in the metastatic setting will not be considered a separate
- •regimen). Generally, treatments that are separated by an event of progression
- •are considered different regimens.
- •7. Have received prior systemic treatment as recommended by National
- •Comprehensive Cancer Network (NCCN) or European Society for Medical
- •Oncology (ESMO) guidelines, including fluoropyrimidines, oxaliplatin,
- •irinotecan or bevacizumab in the metastatic setting or similar
- •treatments, as per local guidelines.
- •8. No known contraindications to study treatment., Screening Inclusion
- •Criteria:, 1. Patients must meet all Prescreening inclusion criteria.
- •2. Provide a personally signed and dated Screening ICF.
- •3. mCRC categorized as MSS by immunohistochemistry (IHC) or
- •polymerase chain reaction (PCR)-based local assay at any time prior to
- •Screening or by the central laboratory.
- •4. RAS mutation per local assay at any time prior to Screening or by the
- •central laboratory.
- •5. Have received at least 1 prior line of systematic therapy in the
- •metastatic setting as recommended by National Comprehensive Cancer
- •Network (NCCN) or European Society for Medical Oncology (ESMO)
- •guidelines, including fluoropyrimidines, oxaliplatin, irinotecan or
- •bevacizumab, or similar treatments, as per local guidelines, and meets at
- •least one of the following criteria:
- •a. were unable to tolerate the prior first-line regimen
- •b. experienced disease progression during or after prior first-line
- •regimen for metastatic disease
- •c. progressed during or within 6 months of completing adjuvant
- •chemotherapy
- •Note: Generally, treatments that are separated by an event of
- •progression are considered different regimens.
- •6. Eastern Cooperative Oncology Group (ECOG) performance status (PS)
- •of 0 or 1.
- •7. Female patients are either postmenopausal for at least 1 year, are
- •surgically sterile for at least 6 weeks; if a female patient is of
- •childbearing potential, she must agree to follow instructions for
- •acceptable or highly effective method(s) of contraception for the
- •duration of study treatment and for 5 months after the last dose of study
- •treatment with nivolumab (i.e., 30 days [duration of ovulatory cycle]
- •plus the time required for the investigational drug to undergo
- •approximately 5 half-lives)
- 另有 6 项未显示
排除标准
- •Prescreening Exclusion Criteria:, 1. Prior treatment with any MEK inhibitor.
- •2. Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-
- •CD137, or anti-CTLA-4 antibody, or any other antibody or drug
- •specifically targeting T-cell co-stimulation or checkpoint pathways.
- •3. Any untreated central nervous system (CNS) lesion. However, patients
- •are eligible if: a) all known CNS lesions have been treated with
- •radiotherapy or surgery, and b) patients remained without evidence of
- •CNS disease progression * 4weeks after treatment, and c) patients must
- •be off corticosteroid therapy for * 3 weeks.
- •4. Patients with an active, known or suspected autoimmune disease, with the
- •following exceptions:
- •patients with type I diabetes mellitus, hypothyroidism only requiring
- •hormone replacement, skin disorders (such as vitiligo, psoriasis, or
- •alopecia) not requiring systemic treatment, or conditions not expected
- •to recur in the absence of an external trigger are permitted to enroll.
- •5. Partial or complete bowel obstruction.
- •6. Impaired gastrointestinal function or disease that may significantly
- •alter the absorption of binimetinib (e.g., ulcerative diseases,
- •uncontrolled vomiting, malabsorption syndrome, small bowel resection
- •with decreased intestinal absorption) or baseline diarrhea * Grade 1.
- •7. Known history of RVO.
- •8. Concurrent or previous other malignancy within 5 years of study
- •entry, except cured basal or squamous cell skin cancer, superficial
- •bladder cancer, prostate intraepithelial neoplasm, carcinoma in-situ of
- •the cervix, or other noninvasive or indolent malignancy
- •9. Known history of Gilbert's syndrome.
- •10. Severe uncontrolled medical illness.
- •11. Psychiatric illness inhibiting informed consent or protocol
- •compliance.
- •12. Pregnant or breastfeeding females.
- •13. History of severe hypersensitivity reactions to mAbs.
- •14. History of allergy or intolerance (unacceptable AEs) to study drug
- •components or polysorbate-80-containing infusions., Screening Exclusion
- •Criteria:, 1. Patients must not meet any of the Prescreening exclusion criteria.
- •2. Treatment with systemic immunosuppressive medications (including
- •but not limited to prednisone, cyclophosphamide, azathioprine,
- •methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF]
- •agents) within 2 weeks prior to first day of study treatment:
- •a. The use of inhaled corticosteroids and mineralocorticoids (e.g.,
- •fludrocortisone) and topical steroids are allowed. Patients who have
- •received acute and/or low-dose systemic immunosuppressant
- •medications (e.g., a one-time dose of dexamethasone for nausea or
- •chronic use of * 10 mg/day of prednisone or dose-equivalent
- •corticosteroid) may be enrolled in the study after discussion with and
- •approval by the Sponsor's Medical Monitor.
- •3. Impaired gastrointestinal function or disease that may significantly
- •alter the absorption of binimetinib (e.g., ulcerative diseases,
- •uncontrolled vomiting, malabsorption syndrome, small bowel resection
- •with decreased intestinal absorption) or baseline diarrhea * Grade 1.
- •4. History of thromboembolic or cerebrovascular events * 6 months prior
- 另有 4 项未显示
研究者
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