NL-OMON47607已完成不适用
A Phase 1/2a Study of BMS-986179 Administered in Combination with Nivolumab (BMS-936558) in Subjects with Advanced Solid Tumors - CA013-004 Phase I/IIa BMS-986179 plus nivolumab in solid tumors
Bristol-Myers Squibb0 个研究点目标入组 15 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
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 64（—）
入选标准
- •Signed informed consent including consent for submission of a fresh tumor
- •sample (and if available archival).
- •At least 18 years old and have histological or cytological confirmation of a
- •malignancy that is advanced (metastatic and unresectable) with measureable
- •disease and have at least 1 lesion that is biopsy-accessible.
- •For parts 1A and 1B
- •Subjects must have received, and then progressed or been intolerant to, at
- •least 1 standard treatment regimen in the advanced or metastatic setting, if
- •such a therapy exists. Subjects who refuse or are ineligible for standard
- •therapy will be allowed to enroll provided their refusal/ineligibility is
- •documented in medical records
- •All solid tumor histologies will be permitted except for subjects with primary
- •CNS tumors or with CNS metastases as the only site of active disease.
- •Subjects must have either NSCLC, RCC, CRPC, SCCHN, melanoma or pancreatic
- •Subjects must have received, and then progressed or been intolerant to, at
- •least 1 standard treatment regimen.
- •All Subjects
- •Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance
- •status of * 1.
- •Subjects who have prior exposure to any agent specifically targeting checkpoint
- •pathway inhibition or any agent specifically targeting T-cell co-stimulation
- •pathways are permitted after at least a 4 week washout period.
- •Prior palliative radiotherapy must have been completed at least 2 weeks prior
- •to first dose of the study drug.
- •Subjects must have adequate organ function
- •Ability to comply with treatment, PK, immunogenicity, biomarker, and PD sample
- •collection, and required study follow-up.
排除标准
- •Subjects with known or suspected CNS metastases, untreated CNS metastases, or
- •with the CNS as the only site of disease are excluded.
- •Subjects with carcinomatous meningitis are excluded
- •Subjects who have participated in any prior clinical study with nivolumab in
- •which OS is listed as the primary or co primary endpoint and which has not
- •completed analysis based on the primary endpoint are excluded.
- •For subjects with pancreatic cancer those subjects with clinically relevant
- •ascites at baseline or with moderate radiographic ascites are excluded.
- •Subjects with a prior malignancy, different from the one used for enrolment in
- •this study, diagnosed less than 2 years ago are excluded.
- •Any anti-cancer therapy within 4 weeks of the start of study drug
- •Subjects who have received prior therapy with an anti-CD73 antibody, an
- •anti-CD39 antibody, or an adenosine 2A receptor inhibitor are excluded
- •Subjects with active, known or suspected autoimmune disease.
- •Subjects with interstitial lung disease or chronic obstructive pulmonary disease
- •Subjects with a condition requiring systemic treatment with either
- •corticosteroids (> 10 mg daily prednisone equivalents) or other
- •immunosuppressive medications
- •Subjects with uncontrolled or significant cardiovascular disease
- •Subjects with active hepatitis, active bacterial, viral, or fungal infections,
- •a known history of testing positive for human immunodeficiency virus (HIV)
- •Subjects who have undergone any major surgery within 4 weeks of study drug
- •administration are excluded
- •Subjects with a history of any significant drug allergy or ongoing adverse
研究者
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