EUCTR2019-001172-11-ES进行中（未招募）1 期
A Multicenter, Open-Label, Single-ARm, PHase II Clinical Trial to Evaluate the Efficacy and Safety of INCMGA00012 in Advanced Penile SquamoUS Cell Carcinoma. ORPHEUSPhase II Study of the Efficacy of INCMGA00012 in Penile Squamous Cell Carcinoma(ORPHEUS) - Phase II Study of the Efficacy of INCMGA00012 in Penile Squamous Cell Carcinoma (ORPHEUS
Medica Scientia Innovation Research (MedSIR)0 个研究点目标入组 15 人开始时间: 2020年1月14日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
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
- Male
入选标准
- •Patients must meet ALL of the following inclusion criteria to be eligible for enrolment into the study:
- •Patients have been informed about the nature of study, and have agreed to participate in the study, and signed the informed consent form (ICF) prior to participation in any study-related activities.
- •Male patients = 18 years of age at the time of signing ICF.• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1.
- •Life expectancy =12 weeks.
- •Histologically-proven PSqCC.
- •Locally advanced unresectable or metastatic stage 4 PSqCC that is not amenable to resection with curative intent (T4 or N3 or M1).
- •Radiological evidence of locally advanced or metastatic disease.
- •Patients must have measurable disease or evaluable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v.)1.1 criteria.•
- •Willingness and ability to provide blood samples (liquid biopsy) at the time of inclusion, after 2 cycles of study treatment (C3D1), and upon PD or study termination.
- •Adequate organ function:
- •Hematological: White blood cell (WBC) count > 3.0 x 109/L, absolute neutrophil count (ANC) = 1.5 x 109/L, platelet count = 75.0 x109/L, and hemoglobin > 9.0 g/dL.
- •Hepatic: Bilirubin = 1.5 times the upper limit of normal (× ULN) (< 3 x ULN in the case of Gilbert’s disease); aspartate transaminase (AST), and alanine transaminase (ALT) = 2.5 times × ULN (in the case of liver metastases = 5 × ULN); Albumin > 2.5 mg/mL.
- •Serum creatinine = 1.5 x ULN; alternately measured
- •or calculated creatinine clearance =30 mL/min with
- •creatinine levels >1.5 × institutional ULN (glomerular
- •filtration rate [GFR] can also be used in place of creatinine
- •or creatinine clearance).
- •Coagulation: Activated Partial Thromboplastin Time (aPTT)
- •=1.5 X ULN and International Normalized Ratio (INR) orProthrombin Time (PT) =1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is
- •within therapeutic range of intended use of anticoagulants.
- •Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.• Subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 180 days after the last dose of study treatment.
- •Patients that have received prior chemotherapy regimens or radiotherapy for locally recurrent and/or metastatic disease are not excluded but patients nai¨ve of systemic treatment can also be included.
- •For pretreated patients, last dose of chemotherapy administered = 28 days from study entry.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 18
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 18
排除标准
- •1. Locally PSqCC candidate for curative treatment.
- •2. Prior therapy with an anti–PD-1, anti–PD-L1, or anti–PD-L2
- •3. Known hypersensitivity to any of the excipients of
- •INCMGA00012.
- •4. Receipt of anticancer therapy or participation in another
- •interventional clinical study within 28 days before the first
- •administration of study drug; 6 weeks for mitomycin C.
- •5. Radiotherapy within 14 days of first dose of study treatment with
- •the following caveat: 28 days for pelvic radiotherapy.
- •6. Toxicity of prior therapy that has not recovered to = Grade 1 or
- •baseline (with the exception of any grade of alopecia and
- •anemia not requiring transfusion support). Endocrinopathy, if
- •well-managed, is not exclusionary and should be discussed
- •with Sponsor’s medical monitor.
- •7. Major surgery (defined as requiring general anesthesia) or
- •significant traumatic injury within 4 weeks of start of study drug,
- •or patients who have not recovered from the side effects of any
- •major surgery, or patients who may require major surgery
- •during the study.
- •8. Known active uncontrolled or symptomatic Central Nervous
- •System (CNS) metastases, carcinomatous meningitis, or
- •leptomeningeal disease as indicated by clinical symptoms,
- •cerebral edema, and/or progressive growth. Patients with a
- •history of CNS metastases or cord compression are eligible if
- •they have been definitively treated (e.g., radiotherapy,
- •stereotactic surgery) and are clinically stable off anticonvulsants
- •and steroids for at least 4 weeks before randomization.
- •9. Metabolic: Uncontrolled hyper/hypothyroidism or diabetes
- •mellitus type 1 (T1DM). Patients with hypothyroidism stable on
- •hormone replacement will not be excluded from the trial.
- •Patients with controlled T1DM on a stable insulin regimen may
- •be eligible for this study.
- •10. Diagnosis of immunodeficiency or is receiving systemic steroid
- •therapy or immunosuppressive therapy within seven days prior
- •to study treatment initiation.
- •11. Active autoimmune disease that has required systemic
- •treatment in past 2 years (i.e., with use of disease modifying
- •agents, corticosteroids, or immunosuppressive drugs).
- •Note: Replacement therapy (e.g., thyroxine, insulin, or
- •physiologic steroid replacement therapy (= 10 mg prednisone
- •daily) for adrenal or pituitary insufficiency, etc.) is not
- •considered a form of systemic treatment.
- •12. Prior allogenic stem cell or solid organ transplantation.
- •13. Has received a live vaccine within 28 days of the planned start
- •of study drug.
- •Note: Examples of live vaccines include, but are not limited to,
- •the following: measles, mumps, rubella, chicken pox/zoster,
- •yellow fever, rabies, Bacillus Calmette–Guérin (BCG), and
- •typhoid vaccine. Seasonal influenza vaccines for injection are
- •generally killed virus vaccines and are allowed; however,
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