NL-OMON55669已完成不适用
A Phase I/II Study of MEDI4736 (Anti-PD-L1 Antibody) in Combination with Olaparib (PARP inhibitor) in Patients with Advanced Solid Tumors - MEDIOLA - D081KC00001
Astra Zeneca0 个研究点目标入组 27 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
- 27
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
- •Inclusion criteria are presented separately for each cohort of Modules 1 to 7
- •Small cell lung cancer cohort:
- •Patients must have histologically or cytologically confirmed progressive
- •metastatic or recurrent solid tumor (as defined below for each tumor
- •type). To be enrolled in the SCLC cohort, only the tumor types and
- •settings described below are allowed (see in the Protocol)
- •At least 1 measurable lesion that can be accurately assessed at baseline
- •by computed tomography (CT) (or magnetic resonance imaging [MRI]
- •where CT is contraindicated) and is suitable for repeated assessment as
- •per RECIST 1.1. The baseline scan must be obtained
- •within 28 days prior to the first dose of olaparib. Biomarker-only disease
- •is not considered evaluable.
- •Breast cancer cohort:
- •Patients must have histologically or cytologically confirmed progressive
- •metastatic or recurrent solid tumor (as defined below for each tumor
- •type). To be enrolled in the gBRCAm breast cancer cohort, only the
- •tumor types and settings described below are allowed (see in the
- •At least 1 measurable lesion that can be accurately assessed at baseline
- •by computed tomography (CT) (or magnetic resonance imaging [MRI]
- •where CT is contraindicated) and is suitable for repeated assessment as
- •per RECIST 1.1. The baseline scan must be obtained
- •within 28 days prior to the first dose of olaparib. Biomarker-only disease
- •is not considered evaluable.
- •gBRCAm human epidermal growth factor receptor 2 (HER2)-negative
- •breast cancer patients with metastatic or locally advanced disease,
- •which is unresectable (or the patient is not a candidate for resection),
- •may be first, second or third line but all patients must meet the following
- •specific criteria:
- •Must have confirmation of a germline mutation in BRCA1 or BRCA2 that
- •is predicted to be deleterious or suspected deleterious (known or
- •predicted to be detrimental/lead to loss of function).
- •Must have previously received treatment with an anthracycline (eg,
- •doxorubicin, epirubicin) unless contraindicated and/or a taxane (eg,
- •paclitaxel, docetaxel) in either a neo-adjuvant/adjuvant or metastatic
- •For all ovarian cancer (OC) cohorts:
- •Patients must have histologically confirmed recurrent ovarian cancer.
- •Patients must be naïve to prior PARP inhibitor treatment and
- •immunotherapy naïve
- •Patients must have had at least 1 prior line of platinum-based therapy
- •and be platinum sensitive (relapsed >= 24 weeks after administration of
- •last platinum treatment).
- •For 1st stage gBRCAm OC and 2nd stage expansion OC cohorts:
- •Patients must have a gBRCA mutation.
- •For 2nd stage doublet and triplet non-gBRCAm OC cohorts:
- •Patients must not have a gBRCA mutation.
- •Gastric cancer cohort:
- •Patients must have histologically or cytologically confirmed progressive
- •metastatic or recurrent solid tumor (as defined below for each tumor
- •type). To be enrolled in the gastric cancer cohort, only the tumor types
- •and settings described below are allowed (see in the
- 另有 6 项未显示
排除标准
- •Exclusion criteria are presented separately for each cohort in Modules 1 to 7
- •Small cell lung cancer cohort:
- •Prior chemotherapy or other systemic anticancer therapy (eg, targeted
- •biotherapy or hormonal agents) within 4 weeks prior to start of olaparib
- •treatment; 6 weeks for nitrosoureas or mitomycin. Exceptions and
- •treatments of particular importance are noted below (see Protocol)
- •Radiation therapy within 4 weeks prior to start of olaparib treatment
- •(includes radiation targeting bone metastases) or radionuclide
- •treatment within 6 weeks of treatment start.
- •Patients with mixed small cell and non-small cell lung cancer histology.
- •Breast cancer cohort:
- •Prior chemotherapy or other systemic anticancer therapy (eg, targeted
- •biotherapy or hormonal agents) within 4 weeks prior to start of olaparib
- •treatment; 6 weeks for nitrosoureas or mitomycin. Exceptions and
- •treatments of particular importance are noted below (see the Protocol).
- •Radiation therapy within 4 weeks prior to start of olaparib treatment
- •(includes radiation targeting bone metastases) or radionuclide
- •treatment within 6 weeks of treatment start.
- •Patients with HER2-positive disease (3+ by immunohistochemistry [IHC]
- •or in situ hybridization amplified >=2.0).
- •Patients cannot have received more than 2 prior lines of cytotoxic
- •chemotherapy for metastatic disease. Prior treatments with hormonal
- •therapy and non-hormonal targeted therapy are allowed and not counted
- •as a prior line of cytotoxic chemotherapy. For the purposes of this
- •protocol, the combination of an aromatase inhibitor and everolimus or
- •palbociclib, are not considered cytotoxic chemotherapy.
- •BRCA1 and/or BRCA2 variants that are considered to be non-detrimental
- •(eg, Variants of uncertain clinical significance or Variant of unknown
- •significance or Variant, favor polymorphism or benign
- •polymorphism etc).
- •1st stage OC cohort:
- •Prior chemotherapy or other systemic anticancer therapy within 4 weeks
- •prior to start of study treatment.
- •Radiation therapy within 4 weeks prior to start of olaparib treatment.
- •Other malignancy within 5 years.
- •2nd stage cohorts (expansion OC, doublet OC and triplet cohorts)
- •Same as 1st stage gBRCAm OC cohort
- •Patients who received more than 3 prior lines of chemotherapy.
- •Gastric cancer cohort:
- •Prior chemotherapy or other systemic anticancer therapy (eg, targeted
- •biotherapy or hormonal agents) within 4 weeks prior to start of olaparib
- •treatment; 6 weeks for nitrosoureas or mitomycin. Exceptions and
- •treatments of particular importance are noted below (see in the
- •Radiation therapy within 4 weeks prior to start of olaparib treatment
- •(includes radiation targeting bone metastases) or radionuclide
- •treatment within 6 weeks of treatment start
- •For HER2-negative patients: More than 1 prior chemotherapy regimen
- •(except for adjuvant/neoadjuvant chemotherapy with more than 6
- •months wash-out period) for the treatment of gastric cancer in the
- •metastatic or recurrent setting.
- 另有 5 项未显示
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