NL-OMON54331招募中2 期
A Randomized, Open-label Phase 2 Clinical Trial of BMS-986012 in Combination with Carboplatin, Etoposide, and Nivolumab as First-line Therapy in Extensive-stage Small Cell Lung Cancer - CA001-050
Bristol-Myers Squibb0 个研究点目标入组 16 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 16
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
- •1. Participants must have histologically or cytologically documented Extensive
- •Stage Small Cell Lung Cancer (ES SCLC). Participants must present with
- •extensive stage IV disease based on the American Joint Committee on Cancer, 7th
- •edition guidelines. The following grades will be considered: T any, N any, M1a,
- •or M1b, or T3-4 due to multiple lung nodules that are too extensive or tumour
- •or nodal volume that is too large to be encompassed in a tolerable radiation
- •plan. 2. a. Archived tumor specimens, in the form of blocks or sectioned
- •slides, are mandatory for all participants except those participating in the
- •separate PET tracer sub-study for whom the archived tumor specimen is optional.
- •b. Participants taking part in the separate PET tracer sub-study must provide a
- •fresh tumor biopsy from any disease site (primary or metastatic). Mandatory
- •minimum of 3 cores to be processed as 2 fresh frozen and the rest as formalin
- •fixed paraffin embedded. Refer to Section 9.8.1 and the Laboratory Manual for
- •further details on procedures for collecting fresh tumor samples. Note: if
- •during the attempt to collect the tumor biopsy there are safety issues and a
- •sample may not be obtained or is not suitable for the study per protocol
- •requirements, the participant may still be allowed to enter in the study after
- •consultation with BMS Medical Monitor. 3. Eastern Cooperative Oncology Group
- •(ECOG) Performance Score (PS) 0 or 1. 4. Participants must have at least 1
- •measurable lesion, measured by computed tomography (CT) or magnetic resonance
- •imaging (MRI). This will be evaluated per Response Evaluation Criteria in Solid
- •Tumours version 1.1 (RECIST v1.1) criteria. 5. Participants must be suitable to
- •receive a platinum-based chemotherapy regimen as per locally approved drug
- •labels and institutional guidelines. 6. Adequate hematologic and end organ
- •function as defined below: a. Absolute neutrophil count >= 1,500/mm3 (stable off
- •any growth factor within 2 weeks of the first study drug administration) b.
- •Platelets >= 100,000/mm3 (transfusion to achieve this level is not permitted
- •within 2 weeks of the first study drug administration) c. Hemoglobin >= 9 g/dL
- •(transfusion to achieve this level is not permitted within 2 weeks of the first
- •study drug administration) d. White blood cells >= 2000/mm3 e. Total bilirubin <=
- •1.5 x upper limit of normal (ULN) f. Aspartate aminotransferase (AST; serum
- •glutamic-oxaloacetic transaminase) and alanine aminotransferase (ALT; serum
- •glutamic-pyruvic transaminase) <= 3 x ULN g. Serum creatinine <= 1.5 x ULN or
- •calculated creatinine clearance > 50 mL/min (using the Cockcroft-Gault formula)
- •7. Males and Females aged 18 years or older a. Women who are not of
- •childbearing potential are exempt from contraceptive requirements b. Women
- •participants must have documented proof that they are not of childbearing
- •potential c. Women of Childbearing Potential (WOCBP) must have a negative
- •highly sensitive urine or serum pregnancy test (minimum sensitivity 25 IU/L or
- •equivalent units of human chorionic gonadotropin (HCG) within 24 hours prior to
- •the start of study treatment). An extension up to 72 hours prior to the start
- •of study treatment is permissible in situations where results cannot be
- •obtained within the standard 24-hour window. d. WOCBP must agree to follow
- •instructions f
排除标准
- •1. Medical Conditions a. Women who are pregnant or breastfeeding. b. Any
- •significant acute or chronic medical illness that would interfere with study
- •treatment or follow-up c. Inability to undergo venepuncture and/or tolerate
- •venous access. d. Any other sound medical, psychiatric, and/or social reason as
- •determined by the investigator e. Participants with symptomatic brain or other
- •central nervous system (CNS) metastases. Participants are eligible if brain or
- •other CNS metastases are asymptomatic and do not require immediate treatment or
- •have been adequately treated. They must have neurologically returned to
- •baseline (except for residual signs or symptoms related to the CNS treatment)
- •for at least 2 weeks prior to randomization. In addition, participants must be
- •either off corticosteroids or on a stable or decreasing dose of <= 10 mg daily
- •prednisone (or equivalent) for at least 2 weeks prior to randomization. f.
- •Paraneoplastic autoimmune syndrome requiring systemic treatment. g. History of
- •idiopathic pulmonary fibrosis, drug-induced pneumonitis, idiopathic
- •pneumonitis, organizing pneumonia, or evidence of active pneumonitis on
- •screening chest CT scan. History of radiation pneumonitis is permitted. h.
- •Grade >= 2 peripheral sensory neuropathy at study entry. i. Participant has
- •uncontrolled or active systemic fungal, bacterial, viral, or other infection
- •despite appropriate anti-infective treatment, within 7 days prior to the first
- •dose of study drug. j. Known human immunodeficiency virus (HIV) positive with
- •an acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection
- •within the past year or a current CD4 count < 350 cells/uL. Participants with
- •known HIV are eligible if: i.) They have received antiretroviral therapy (ART)
- •for at least 4 weeks prior to randomisation as clinically indicated while
- •enrolled on study ii.) They continue on ART as clinically indicated while
- •enrolled on study iii.) CD4 counts and viral load are monitored as per standard
- •of care by a local health care provider. NOTE: Testing for HIV must be
- •performed at sites where mandated locally. HIV-positive participants must be
- •excluded where mandated locally (see Appendix 8). k. Significant uncontrolled
- •cardiovascular disease, including, but not limited to, any of the following:
- •i.) Uncontrolled hypertension, which is defined as systolic blood pressure >
- •160 mm Hg or diastolic blood pressure > 100 mm Hg, despite optimal medical
- •management. ii.) Active coronary artery disease, including unstable or newly
- •diagnosed angina within 3 months of study enrollment. iii.) Myocardial
- •infarction in the past 6 months. iv.) History of congenital long QT syndrome.
- •v.) History of clinically significant arrhythmias, such as ventricular
- •tachycardia, ventricular fibrillation, or Torsade de pointes. vi.)Uncontrolled
- •heart failure, defined as Class 3 or 4 by New York Heart Association functional
- •classification. vii.) History or current diagnosis of myocarditis. l.
- •Participants with an active, known or suspected autoimmune disease or
- •inflammatory disorder. Participants 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 trig
研究者
相似试验
进行中（未招募）
2 期
A Randomized Study of BMS-986012 in Combination with Carboplatin, Etoposide, and Nivolumab in Participants with Extensive-stage Small Cell Lung CancerExtensive-stage Small Cell Lung CancerJPRN-jRCT2051210111Tannenbaum-Dvir Sarah10
进行中（未招募）
1 期
An Investigational Study of Immunotherapy Combinations withChemotherapy in Patients with Gastric or Gastroesophageal Junction (GEJ)CancersEUCTR2018-001069-18-ITBRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO420
进行中（未招募）
1 期
An Investigational Study of Immunotherapy Combinations with Chemotherapy in Patients with Gastric or Gastroesophageal Junction (GEJ) CancersGastric or Gastroesophageal Junction AdenocarcinomaMedDRA version: 21.1Level: PTClassification code 10017758Term: Gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: LLTClassification code 10056267Term: Gastroesophageal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2018-001069-18-ATBristol-Myers Squibb International Corporation420
进行中（未招募）
1 期
An Investigational Study of Immunotherapy Combinations with Chemotherapy in Patients with Gastric or Gastroesophageal Junction (GEJ) CancersGastric or Gastroesophageal Junction AdenocarcinomaMedDRA version: 21.1Level: PTClassification code 10017758Term: Gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: LLTClassification code 10056267Term: Gastroesophageal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2018-001069-18-NOBristol-Myers Squibb International Corporation420
进行中（未招募）
1 期
An Investigational Study of Immunotherapy Combinations with Chemotherapy in Patients with Gastric or Gastroesophageal Junction (GEJ) CancersEUCTR2018-001069-18-DEBristol-Myers Squibb International Corporation420