EUCTR2017-000976-27-NL进行中（未招募）1 期
Biomarker discovery study to identify patients with advanced urothelial cancer benefitting from pembrolizumab treatment - RESPONDER
Erasmus MC Cancer Institute0 个研究点目标入组 80 人开始时间: 2017年7月12日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
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
入选标准
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- •1.Should have signed informed consent for CPCT-02.
- •Note: when a safe biopsy of a metastatic or locally advanced lesion is not deemed possible by the treating investigator, subject may be included in the trial without participation in the CPCT-02 trial only upon approval by the central principal investigator.
- •2.Be willing and able to provide written informed consent for the trial.
- •3.Be ? 18 years of age on day of signing informed consent.
- •4.Have histologically or cytologically-confirmed urothelial cancer that is not
- •amenable to curative treatment with local and/or systemic therapies.
- •5.Second-line treatment: have progressive disease after platinum containing chemotherapy as defined by:
- •-Disease progression after treatment with a platinum-containing regimen for recurrent (disease not amenable to curative treatment)/metastatic disease
- •-Recurrence/progression within 12 months of prior therapy containing platinum
- •First-line treatment: have received no prior systemic chemotherapy for advanced/unresectable (inoperable) or metastatic urothelial
- •a.Adjuvant platinum based chemotherapy, following radial cystectomy, with recurrence > 12 months from completion of therapy is permitted
- •b.Neoadjuvant platinum based chemotherapy, with recurrence > 12 months since completion of therapy is permitted.
- •Note: Low-dose chemotherapy (e.g., low dose cisplatin, cisplatin+5FU, mytomycin+5FU, or cisplatin+paclitaxel) given concurrent with radiation to the primary tumor site is not considered as systemic therapy.
- •And subject must be considered ineligible to receive cisplatin-based combination therapy, based on having at least one of the following criteria:
- •a.Creatinine clearance (calculated or measured) < 60 mL/min but >30 mL/min
- •Note: Subjects with a creatinine clearance (calculated or measured) < 30 mL/min or on dialysis are excluded from the trial.
- •b.CTCAE v.4, Grade >2 audiometric hearing loss (25dB in two consecutive wave ranges)
- •c.CTCAE v.4, Grade >2 peripheral neuropathy
- •d.NYHA Class III heart failure (Appendix 13.1)
- •6.Cisplatin-unfit patients should have a PD-L1 CPS of ?10, determined with the use of the commercially available PD-L1 IHC 22C3 pharmDx assay on a DAKO stainer.
- •PD-L1 expression may be determined prior to enrollment or during the screening phase.
- •7.Have measurable disease based on RECIST 1.1. Tumor lesions located in a previously irradiated area are considered measurable if progression has been demonstrated in these lesions.
- •8.Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly
- •8.-Note: newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 1. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the Sponsor.
- •-Note: when a safe biopsy of a metastatic or locally advanced lesion is n
排除标准
- •1. Treamtent with an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
- •2. Has a diagnosis of immunodeficiency or is receiving high dose systemic steroid therapy (defined as > 20 mg prednisone or equivalent per day) or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
- •3. Has a known history of active TB (Bacillus Tuberculosis).
- •4. Hypersensitivity to pembrolizumab or any of its excipients.
- •5. Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., = Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
- •6. Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., = Grade 1 or at baseline) from adverse events due to a previously administered agent.
- •- Note: Subjects with = Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
- •- Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
- •- Note: Radiation therapy to a symptomatic solitary lesion or to the brain may be allowed at the investigator’s discretion
- •7. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or
- •squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
- •Diagnosis of prostate carcinoma in cystectomy material is not an exclusion criterium.
- •8. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain
- •metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose
- •of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and
- •are not using high dose steroids (defined as > 20 mg prednisone or equivalent per day) for at least 7 days prior to trial treatment. This
- •exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
- •9. 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 (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- •10. Has known history of, or any evidence of active, (non-infectious) pneumonitis that required steroids, evidence of interstitial lung disease or active, non-infectious pneumonitis.
- •11. Has an active infection requiring systemic therapy.
- •12. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the sub
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