EUCTR2020-003429-41-ES进行中（未招募）1 期
iVOlumab for Luminal advanced/metastatic breast cancer to Taper ct-dnA In endocrine REsistance (VOLTAIRE trial) - VOLTAIRE
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- SOLTI
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Male/female participants who are at least 18 years of age.
- •2.Men/Women with advanced BC not amenable to curative therapy.
- •3.Patients with luminal BC defined by histologically documented HR+ and HER2- tumors by local testing:
- •a)HER2 negativity is defined as either of the following by local laboratory assessment: IHC 0, IHC 1+ or IHC2+/in situ hybridization (ISH) negative as per most recent American Society of Clinical Oncology (ASCO)-College of American Pathologists Guideline (CAP) guideline (ISH negative is defined as a ratio of HER2 to CEP17 <2.0).
- •b)ER and/or PgR positivity are defined as >1% of cells expressing HR via IHC analysis as per most recent ASCO-CAP guideline.
- •4.The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
- •5.Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- •6.Postmenopausal, as defined by the study protocol.
- •7.Pre/perimenopausal.
- •8.Patients who have not received or have received one ET line for advanced BC.
- •9.Prior radiation therapy for metastatic disease is permitted. Patients must have recovered from radiotherapy toxicities prior to allocation.
- •10.Availability of formalin-fixed paraffin-embedded (FFPE) tumour block for biomarker analysis. See Section 10.1.1 (Tumor Tissue Samples).
- •11.Participants must have the ability to swallow oral medication.
- •12.easurable disease or non-measurable (but evaluable), as defined by RECIST v1.1.
- •13.Adequate hematologic and end-organ function, defined by the following laboratory results (Table 5 of the protocol) obtained within 3 days prior to Cycle 1, Day 1.
- •14.Have corrected QT interval of = 470 milliseconds on screening ECG.
- •Male participants:
- •15.A male participant must agree to use contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 5 months after the last dose of nivolumab and refrain from donating sperm during this period.
- •Female participants:
- •16.A female participant is eligible to participate if she is not pregnant, not breastfeeding (see Appendix 3 of the protocol).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1. A WOCBP who has a positive urine pregnancy test within 72 hours prior to the allocation (see Appendix 3).
- •2.Has received prior therapy with an anti-PD1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor.
- •3.Prior therapy with any CDK4/6 inhibitors as therapy for advanced BC. Note: Prior therapy with CDK4/6 inhibitors as (neo)adjuvant treatment is allowed whenever the patient has progress > 12 months since last dose of CDK4/6 inhibitor.
- •4. Patients who received more than two chemotherapy line for advanced BC.
- •5. No resolution of all acute toxic effects of prior anti-cancer therapy or major surgical procedures to NCI CTCAE version 5.0 Grade = 1
- •6. Uncontrolled pleural effusion, pericardial effusion, or ascites
- •7.Uncontrolled hypercalcemia (>1.5 mmol/L [>6 mg/dL] ionized calcium or serum calcium [uncorrected for albumin] >3 mmol/L [>12 mg/dL] or corrected serum calcium >ULN) or clinically significant (symptomatic) hypercalcemia.
- •8. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- •9.Has known active central nervous system metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable.
- •10. Has a history of or active or known autoimmune disease, or other syndrome that requires systemic steroids (> 10 mg daily prednisone equivalent) or autoimmune agents for the past 2 years (see exceptions at the protocol).
- •11.Has a prior allogeneic stem cell or solid organ transplantation.
- •12.Has a personal history of any of the following conditions: syncope of either unexplained or cardiovascular etiology, ventricular arrhythmia, long or short QT syndrome, Brugada syndrome, or known history of corrected QT prolongation, Torsade de Pointes, or sudden cardiac arrest.
- •13.Other nonmalignant systemic disease that would preclude the participant from receiving study treatment or would prevent required follow up.
- •14.Class III or Class IV myocardial disease as described by the New York Heart Association; a recent history (within 6 months prior to enrolment) of myocardial infarction, or symptomatic arrhythmia at the time of allocation/treatment. Has a history of allergy or hypersensitivity (=Grade 3) to study drug components.
- •15.Has received a live/attenuated vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette–Guérin (BCG) and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.
- •Note: It is not recommended the use of live or attenuated COVID-19 vaccines within 30 days of initiation or during study treatment. However, if vaccination with these vaccines is required, please ask for advice on how to proceed the Medical Monitor.
- •16.Has a known history of Human Immunodeficiency Virus (HIV).
- •17.Active hepatitis B or hepatitis C with abnormal liver function tests
- •18.Has a known history of active TB (Bacillus Tuberculosis).
- •19.Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject’s participation for the
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