EUCTR2017-003792-63-GB进行中（未招募）1 期
Phase II trial of maintenance pembrolizumab following weekly paclitaxel for recurrent ovarian, fallopian tube or peritoneal cancer - PROMPT
niversity College London0 个研究点目标入组 28 人开始时间: 2018年9月6日最近更新:
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
- 入组人数
- 28
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
- Female
入选标准
- •1.Patients must have a diagnosis of high grade recurrent ovarian/fallopian tube or primary non-mucinous peritoneal cancer
- •2.Be willing and able to provide written informed consent for the trial, indicating that the patient has been informed of and understands the experimental nature of the study, possible risks and benefits, trial procedures, and alternative options
- •3.Be ? 18 years of age on day of signing informed consent
- •4.Patients should be treated with at least 4 cycles of weekly paclitaxel for their first non-platinum-based therapy. [Non-platinum-based therapy given for CT/MR documented recurrence where further platinum therapy considered unsuitable]
- •5.Patients can have had up to 3 prior lines of treatment for ovarian cancer before starting weekly paclitaxel
- •6.Patients must have achieved at least stable disease or response to a minimum for four cycles of weekly paclitaxel (measured by CT/MR)
- •7.Trial treatment must start within 8 weeks after last paclitaxel dose
- •8.Availability of archival tissue
- •9.Patient has disease amenable to biopsy after paclitaxel
- •10. Patient is willing to have a biopsy at baseline and before start of the 4th cycle of pembrolizumab
- •11.CT chest, abdominal and pelvic scan within 28 days of registration
- •12.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •13.Willing and able to comply with the protocol for the duration of the study, including the treatment plan, investigations required and follow up visits
- •14.Demonstrate adequate organ function as defined in Table 1 of protocol, all screening labs should be performed within 10 days of treatment initiation.
- •15.For patients of childbearing potential should have a negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- •16.For patients of childbearing potential (defined in Section 6.3.1) must be willing to use an adequate method of contraception as outlined in Section 6.3.4 from the start of treatment through to 4 months after the last dose of study medication
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •1.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 T-cell receptor (eg, CTLA-4, OX 40, CD137)
- •2.Has a diagnosis of low grade or mucinous ovarian cancer
- •3.Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment (n.b. the use of physiologic doses of corticosteroids may be approved after consultation with UCL CTC), excepting use of inhaled steroids.
- •4.Has a known history of active TB (Bacillus Tuberculosis)
- •5.Has known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known Hepatitis C virus (defined as HCV RNA [qualitative] is detected)*
- •6.Has a known history of Human Immunodeficiency Virus (HIV). *
- •7.Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks (could consider shorter interval for kinase inhibitors or other short half-life drugs) prior to randomisation.
- •Note: Participants must have recovered from all AEs due to previous therapies to =Grade 1 or baseline. Participants with =Grade 2 neuropathy may be eligible.
- •Note: If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.
- •8.Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (=2 weeks of radiotherapy) to non-CNS disease.
- •9.Patients with concurrent or previous malignancy within the last 5 years (except Stage I grade 1 endometrial cancer; in situ cervical cancer; DCIS of the breast) that could compromise assessment of the primary or secondary endpoints of the trial
- •10.Active central nervous system (CNS) metastases and/or carcinomatous meningitis; patients with previously treated brain metastases may participate provided they are:
- •a) radiologically stable
- •b)without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening)
- •c)clinically stable
- •d)without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
- •11.Has active autoimmune disease that required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids (at doses >10mg prednisolone daily or equivalent) or immunosuppressive drugs) except vitiligo or resolved childhood asthma/atopy. Replacement therapy (e.g. levothyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is permitted
- •12.Has a corrected serum calcium of >1.5 x ULN despite maximal anti-hypercalcaemic therapy
- •13.Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis or has a history of interstitial lung disease
- •14.Has a newly diagnosed venous thrombotic event (e.g. PE, DVT) untreated with anticoagulation. Patients must have received at least 14 days of anticoagulation for a new thrombotic event and be suitable for continued therapeutic anticoagulation during trial participation. Patients are excluded if they have a history of art
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