NL-OMON55840招募中2 期
A Phase 1b-2 study of Mitomycin-C / Capecitabine chemoradiotherapy combined with Ipilumimab and Nivolumab or Nivolumab monotherapy as bladder sparing curative treatment for muscle Invasive bladder Cancer: the CRIMI study. - CRIMI
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
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 Be willing and able to provide written informed consent for the trial.
- •2 Be >= 18 years of age on day of signing informed consent.
- •3 Wish to preserve their bladder function or be ineligible for cystectomy.
- •4 Must have undergone transurethral biopsy of the bladder tumor, within 35
- •days of planned treatment commencement. The patient should have a
- •histologically-confirmed diagnosis of muscle-invasive T2-T4a, N0-1M0 urothelial
- •cell carcinoma of the bladder.
- •5 Must have undergone maximal transurethral resection of the bladder tumour,
- •to an extent that is judged as safe by the urologist performing the resection,
- •within 35 days of planned treatment commencement.
- •6 Subjects with tumors of mixed urothelial/non-urothelial cell histology are
- •allowed, but urothelial cell carcinoma must be the predominant histology
- •(>50%). Subjects with predominant or exclusively non-urothelial cell histology
- •are not allowed.
- •7 Have planned for chemoradiotherapy as definitive treatment.
- •8 Have a performance status of 0 or 1 on the ECOG Performance Scale
- •9 Have a bladder function that is accessible for cystoscopical follow up.
- •10 Demonstrate adequate organ function as defined below. All screening labs
- •should be performed within 28 days of registering the patient on the trial.
- •11 Female participants of childbearing potential should have a negative urine
- •or serum pregnancy within 72 hours prior to registering the patient. If the
- •urine test is positive or cannot be confirmed as negative, a serum pregnancy
- •test will be required.
- •12 Female participants of childbearing potential should be willing to one
- •highly effective method of birth control or be surgically sterile, or abstain
- •from heterosexual activity for the course of the study through 5 month after
- •the last dose of study medication Participants of childbearing potential are
- •those who have not been surgically sterilized or have not been free from menses
- •for > 1 year.
- •13 Male participants should agree to use condoms starting with the first dose
- •of study therapy through 7 month after the last dose of study therapy.
- •14 Willing to consent to the use of their collected tumor specimen, blood and
- •urine as detailed in the protocol for future scientific research including but
- •not limited to DNA, RNA and protein based biomarker detection.
排除标准
- •1 Has DPD deficiency.
- •2 Has concurrent extra-vesical (i.e. urethra, ureter or renal pelvis)
- •urothelial cell carcinoma of the urothelium. Patients who have involvement of
- •the prostatic urethra with urothelial cell cancer may be included if the
- •location can be safely incorporated in the radiation field.
- •3 Extensive or multifocal bladder carcinoma in situ (CIS) precluding curative
- •chemoradiotherapy.
- •4 Evidence of distant metastatic disease on a CT or FDG PET/CT
- •chest/abdomen/pelvis performed within 28 days prior to study entry. Up to 3
- •metastatic lymph nodes in the pelvis (below the common iliac arteries) are
- •allowed, if these can be incorporated in the radiotherapy field.
- •5 Prior pelvic lymph-adenectomy
- •6 Prior pelvic radiotherapy
- •7 Has had prior intravenous chemotherapy, targeted small molecule therapy, or
- •radiation therapy for treatment of bladder cancer. Prior intravesical use of
- •BCG and MMC is permittedssible.
- •8 Unsuitable for concurrent MMC / capecitabine based ChRT based on
- •pre-existing medical conditions.
- •9 Is currently participating and receiving study therapy or has participated
- •in a study of an investigational agent and received study therapy or used an
- •investigational device within 4 weeks prior to the first dose of treatment. An
- •exception is fiducials that are aimed at improving positional stability during
- •the radiotherapy treatment course. These are allowed.
- •10 Has a diagnosis of immunodeficiency or is receiving systemic steroid
- •therapy over 10mg daily prednisone (or equivalent) or any other form of
- •immunosuppressive therapy within 14 days prior to registering the patient.
- •Patients with adrenal insufficiency receiving replacement dose steroids are
- •allowed on the trial.
- •11 Has a known history of active TB (Bacillus Tuberculosis)
- •12 Hypersensitivity to nivolumab and/or ipilimumab or any of its excipients.
- •13 Prior or concurrent known additional malignancy of any site unless disease
- •free for 5 years. 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, Stage T1a well differentiated prostatic
- •carcinoma in men (Gleason = 3+3, PSA <5)
- •14 Has any history of active autoimmune disease, Stevens-Johnson syndrome or
- •Guillain-Barre. Exceptions to this are:
- •a. Patients with autoimmune-related hypothyroidism on a stable dose of thyroid
- •replacement hormone
- •b. Patients with controlled Type I diabetes mellitus on a stable dose of
- •insulin regimen
- •15 Has known history of, or any evidence of active, non-infectious
- •pneumonitis.
- •16 Has an active infection requiring systemic therapy.
- •17 Has a history or current evidence of any condition, therapy, or laboratory
- •abnormality that might confound the results of the trial, interfere with the
- •patient*s participation for the full duration of the trial, or is not in the
- •best interest of the participant to participate, in the opinion of the treating
- •investigator.
- •18 Has known psychiatric or substance abuse disorders that would interfere
- 另有 4 项未显示
研究者
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