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临床试验/NL-OMON52808
NL-OMON52808已完成2 期

PERICLES (PEnile cancer Radio- and Immunotherapy CLinical Exploration Study) - a Phase 2 study of atezolizumab with or without radiotherapy in penile cancer - PERICLES study

Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 32 人开始时间: 待定最近更新:
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适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
32
研究概览入排标准研究者记录与标识符相似试验

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

  • •- Age >= 18 years at time of study entry., - Advanced histologically
  • •documented, squamous cell carcinoma of the penis or distal urethra. Advanced
  • •disease is defined as:, -Distant metastases, OR, -LRAPC, defined as a large or
  • •inoperable primary tumor (T4), palpable nodes >3cm in diameter or fixed
  • •nodes, suspicion of extra-nodal extension or pelvic node involvement (N2/N3),
  • •Arm A: Locoregional disease (with or without distant metastases), likely to
  • •derive benefit from locoregional radiotherapy and not previously treated with
  • •radiotherapy., Arm B: Benefit of locoregional radiotherapy unlikely OR
  • •previously treated with irradiation. , Adequate normal organ and marrow
  • •function as defined below: , -Haemoglobin >= 5.6/mmol/L, -White blood cell
  • •count (WBC) >= 2 x 109/L (> 1500 per mm3), -Absolute neutrophil count (ANC) >=
  • •1.5 x 109/L (> 1500 per mm3), -Platelet count >= 100 x 109/L (>100,000 per
  • •mm3), -Serum bilirubin <= 1.5 x institutional upper limit of normal (ULN). This
  • •will not apply to subjects with confirmed Gilbert*s syndrome, who will be
  • •allowed in consultation with a study physician., -AST/ALT <= 2.5 x institutional
  • •ULN unless liver metastases are present, in which case it must be <= 5x ULN.,
  • •-Serum creatinine clearance >30 mL/min by calculation with the
  • •Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine
  • •collection measurement.

排除标准

  • •1. Involvement in the planning and/or conduct of the study (applies to both
  • •Roche staff and/or staff at the study site). Previous enrolment in the present
  • •study., 2. Participation in another clinical study with an investigational
  • •product during the last 4 weeks, 3. Any previous treatment with a PD1 or PD-L1
  • •inhibitor, 4. History of another primary malignancy except for:, •Malignancy
  • •treated with curative intent and with no known active disease >=2 years before
  • •the first dose of study drug, •Low potential risk of 3-year cancer-specific
  • •death (estimated<5%), including adequately treated non-melanoma skin cancer
  • •without evidence of disease, adequately treated carcinoma in situ without
  • •evidence of disease, or localized prostate cancer treated with curative intent
  • •and absence of prostate-specific antigen (PSA) relapse or incidental prostate
  • •cancer (Gleason score <= 7 and PSA < 10 ng/mL) undergoing active
  • •surveillance., 5. Treatment with the last dose of any systemic anti-cancer
  • •therapy <= 21 days prior to the first dose of study drug. Local treatment of
  • •isolated lesions for palliative intent is acceptable (eg, local surgery or
  • •radiotherapy). , 6. Current or prior use of immunosuppressive medication within
  • •14 days before the first dose of study drug, with the exceptions of intranasal
  • •and inhaled corticosteroids or systemic corticosteroids at systemic doses
  • •below <= 10 mg/day of prednisone, or an equivalent corticosteroid., 7. History
  • •of primary immunodeficiency, allogeneic organ transplant or autoimmune
  • •disease, including, but not limited to, myasthenia gravis, myositis,
  • •autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis,
  • •inflammatory bowel disease, vascular thrombosis associated with
  • •antiphospholipid syndrome, Wegener*s granulomatosis, Sjögren*s syndrome,
  • •Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.*
  • •Patients with a history of autoimmune-related hypothyroidism on a stable dose
  • •of thyroid replacement hormone will not be excluded from this study. Patients
  • •with controlled diabetes mellitus type 1 on a stable dose of insulin regimen
  • •may be eligible for this study. , 8. Uncontrolled intercurrent illness
  • •including, but not limited to, ongoing or active infection (including acute or
  • •chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV),
  • •symptomatic congestive heart failure, unstable angina pectoris, cardiac
  • •arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses
  • •or psychiatric illness/social situations that would limit compliance with study
  • •requirements or compromise the ability of the subject to give written informed
  • •consent, 9. Known active tuberculosis, 10. Any condition that, in the opinion
  • •of the investigator, would interfere with evaluation of study treatment or
  • •interpretation of patient safety or study results, 11. Brain metastases or
  • •leptomeningeal disease. Inclusion of patients with brain metastases is allowed
  • •if patients have been adequately treated and no signs of progression on brain
  • •imaging >=*28 days after completion of treatment (including surgery,
  • •radiotherapy or treatment with systemic corticosteroids). , 12. Subjects with
  • •uncontrolled seizures.

研究者

发起方
Antoni van Leeuwenhoek Ziekenhuis

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