CTIS2023-508155-40-00招募中1 期
Phase II investigational study of pembrolizumab combination with chemotherapy in platinum-sensitive recurrent low-grade serous ovarian cancer - NOGGO-ov44
ord-Ostdeutsche Gesellschaft Fuer Gynaekologische Onkologie e.V.0 个研究点目标入组 33 人开始时间: 2024年1月17日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 33
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
- 年龄范围
- 18 至 65+（—）
入选标准
- •Female, age at least 18 years., Histologically diagnosed low-grade serous ovarian-, fallopian tube- and/or primary peritoneal cancer., Patients must have completed at least 1 previous course of platinum-containing therapy (e.g., combination with carboplatin or cisplatin. Maintenance therapy with bevacizumab and/or endocrine agents (e.g. letrozole) is allowed. Neoadjuvant chemotherapy in the first line therapy will be counted as one line of therapy. Patients may, but are not required to, have a previous cytoreductive surgery in the first as well as in the second line., Patients must have platinum sensitive disease, e.g. progression or recurrence after platinum-containing therapy, occurring no sooner than 6 months after completion of the last dose of platinum chemotherapy., Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1., Women of childbearing potential should not become pregnant while on the study therapy and should not be pregnant at the beginning of treatment. A pregnancy test should be performed on all women of childbearing potential prior to receiving the study therapy. Women of childbearing potential must agree to follow contraceptive guidance in Appendix 3 of the protocol during the treatment period and for 6 months after receiving the last dose of the study therapy., The participant provides written informed consent for the trial., Availability of archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue., Have adequate organ and bone marrow function as defined in Table 1 of the study protocol.
排除标准
- •High-grade ovarian cancer or other than low grade serous ovarian cancer ovarian malignancy., Has a known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded., Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable, i.e. without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment., Has a bleeding tumor, Has hypersensitivity to any of the study drugs the patient will be treated with and/or to any of the excipients of the study drugs the patient will be treated with., Has hypersensitivity to platin-containing compounds other than carboplatin., Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment, Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease., Has an active infection requiring systemic therapy., Has active infection with SARS-CoV-2 (antigen test)., Has a history of Human Immunodeficiency Virus (HIV) infection (known HIV1/HIV2 antibodies positive, mandatory testing for HIV during screening is required)., Persistent =Grade 2 non-hematologic toxicity from prior cancer therapy, Has a history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or active Hepatitis C virus (defined as HCV RNA [qualitative] has been detected) infection (mandatory testing for Hepatitis B and Hepatitis C during screening is required)., Has a known history of active TB (Bacillus Tuberculosis)., 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 full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator., Has had an allogenic tissue/ solid organ transplant., Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial., Is pregnant or breastfeeding, or expecting to conceive within the projected duration of the study, starting with the screening visit through 6 months after the last dose of trial treatment, Patients unable to be regularly followed for any reason (geographic, familiar, social, psychologic, housed in an institution e.g. prison because of a court agreement or administrative order according to § 40 Abs. 1 S. 3 Nr. 4 AMG)., Subjects that are depending on the sponsor/CRO or investigational site as well as on the investigator., Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory
研究者
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