EUCTR2019-001172-11-IT招募中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. ORPHEUS - ORPHEUS
MEDICA SCIENTIA INNOVATION RESEARCH, ARO0 个研究点目标入组 18 人开始时间: 2020年10月21日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 18
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
- 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 agent.
- •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, intranasal influenza vaccines (e.g., FluMist®) are liveattenuated vaccines and are not allowed.
- •14. Active/history of pneumonitis requiring treatment with steroids or active/history of interstitial lung disease.
- •15. Active uncontrolled infection at the time of screening.
- •16. Latent tuberculosis determined by a positive TST followed by confirmation by pulmonologists.
- •17. Participants who are known to be human immunodeficiency virus (HIV)-positive, unless all of the following criteria are met:
- •a. CD4-positive count = 300/µL;
- •b. Undetectable viral load;
- •c. Receiving highly active antiretroviral therapy.
- •18. Active hepatitis A virus (HAV) (positivity for HAV IgM antibody), hepatitis B virus (HBV) (patients with neg
研究者
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