NL-OMON53077已完成2 期
Biomarker discovery study to identify patients with advanced urothelial cancer benefitting from pembrolizumab treatment - RESPONDER
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 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
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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:
- •a. Disease progression after treatment with a platinum-containing regimen for
- •recurrent (disease not amenable to curative treatment)/metastatic disease
- •b. 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
- •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-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 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.
- •9. Have a performance status of 0 or 1 on the ECOG Performance Scale.
- •10. Demonstrate adequate organ function according to screening labs, which
- •should be performed within 10 days of
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
- •- 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
- •- Note: Radiation therapy to a symptomatic solitary lesion 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
- •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
- •subject's participation for the full duration of the trial, or is not in the
- •best interest of the subject to participate, in the opinion of the treating
- •investigator.
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