2024-515080-54-00招募中2 期
Pre-operative phase II trial for breast cancer with nivolumab in combination with novel IO (BELLINI trial)
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年12月2日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- pathological complete response rate per cohort, with a pCR defined as no residual invasively growing tumor cells detected by microscopic examination in breast and axilla.
研究概览
简要总结
To determine whether short-term pre-operative nivolumab either as monotherapy or in combination with ipilimumab or relatlimab or novel IO combinations can induce pathological complete response
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent
- •18 years or older at moment of inclusion
- •Female gender
- •WHO performance status 0 or 1
- •Resectable primary breast cancer stage I-III. Nodal status must be examined by ultrasound, fine needle aspiration, sentinel node biopsy, or FDG-PET scan (cohort 3B, 4B ,5B and 2A and 3A: PET-CT mandatory).
- •The tumors must be: >5 mm (minimum cT1b) as determined by MRI. TNBC (all cohorts B) defined as ER<10%, HER2-negative. Luminal B (cohort 1A) defined as ER≥10%, HER2- negative with either Ki67≥20% or PR ≤20% OR grade 3 AND TIL ≥1%. High-risk ER (cohort 2A and 3A) cT3-4N0 OR clinically node positive AND grade 3 OR grade 2 with ER levels of 50% or lower or TIL≥1%. For cohort 3B: N0 status, TNBC and TIL ≥50%. For cohort 4B: N0 status, TNBC and TIL 30-49%. For cohort 5B: N0 status, TNBC and TIL ≥50%.
- •Patients with multifocal/multicentric breast cancer are eligible if subtype histology as well as sufficient TIL percentages (30-49% in cohort 4B, ≥50% in cohort 5B) have been confirmed in all tumor lesions.
排除标准
- •evidence or suspicion of metastatic disease. Evaluation of the presence of distant metastases may include chest X-ray, liver ultrasound, isotope bone-scan, CT-scan of chest and abdomen and/or FDG-PET scan, according to local procedures
- •other prior invasive malignancy 1) in the breast or 2) localized in the near proximity of the breast, that was treated with radiotherapy at the localization of the new breast tumor
- •occult breast cancer
- •previous anti-cancer hormone therapy or chemotherapy
- •prior treatment with checkpoint inhibitors (including anti-PD1, -PD-L1, -CTLA-4, -LAG3)
- •concurrent anti-cancer treatment, neoadjuvant therapy or another investigational drug (except for neoadjuvant chemotherapy in cohort 2A / 3A)
结局指标
主要结局
pathological complete response rate per cohort, with a pCR defined as no residual invasively growing tumor cells detected by microscopic examination in breast and axilla.
pathological complete response rate per cohort, with a pCR defined as no residual invasively growing tumor cells detected by microscopic examination in breast and axilla.
次要结局
- incidence, nature and severity of Adverse Events graded according to NCI-CTCAE v5.0 collected during treatment and up to 3 weeks post-surgery.
- Radiological response using breast MRI per cohort
- Event-free survival (EFS)
- Overall survival (OS)
- Immune activation after pre-operative nivolumab, either as monotherapy or in combination with ipilimumab or relatlimab or novel IO combinations
研究者
Marleen Kok
Scientific
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
研究点 (1)
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