KCT0008625尚未招募Unknown
Pazopanib with or without Pembrolizumab for Metastatic Soft Tissue Sarcoma: open-label, multicenter, randomized, phase 2 trials
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 116
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
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1. Histologically confirmed STS progression to 1 or 2 (less than 3) prior chemotherapy
- •: Exclude pazopanib-resistant subtype - embryonal rhabdomyosarcoma, chondrosarcoma, osteosarcoma, Ewing tumours, primitive neuroectodermal tumour, gastrointestinal stromal tumour, dermatofibrosarcoma protuberans, inflammatory myofibroblastic sarcoma, and liposarcoma
- •2. Age > 19 years at time of study entry.
- •3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (within 7 days before screening)
- •4. Measurable disease by Response Evaluation Criteria in Solid Tumors Version 1.1
- •5. Adequate normal organ and marrow function as defined below:
- •? Haemoglobin =9.0 g/dL
- •? Absolute neutrophil count (ANC) = 1500 per mm3
- •? Platelet count = 100,000 per mm3
- •? Serum bilirubin =1.5 x institutional upper limit of normal (ULN).
- •? AST (SGOT)/ALT (SGPT) =2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be =5x ULN
- •? Creatinine=1.5 x ULN or Measured or calculated(CrCl should be calculated per institutional standard) creatinine clearance(GFR can also be used in place of creatinine or CrCl) = 1.5 x institutional ULN
- •? International normalized ratio (INR) OR prothrombin time (PT) and activated partial thromboplastin time (aPTT) : =1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants
- •6. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
- •7. A male or female participant must agree to use a contraception as detailed in Appendix 2 of this protocol during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.
- •8. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- •a. Not a woman of childbearing potential (WOCBP) as defined in Appendix 2
- •b. A WOCBP who agrees to follow the contraceptive guidance in Appendix 2 during the treatment period and for at least 120 days after the last dose of study treatment.
- •9. Archival tumor tissue sample or newly obtained [core, incisional or excisional] biopsy of a tumor lesion not previously irradiated has been provided. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue
排除标准
- •1. Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) 28 days prior to the first dose of study drug
- •2. Any previous treatment with a PD1 or PD-L1 inhibitor, anti-PD-L2 agent, stimulatory/co-inhibitory T-cell receptor (eg. CTLA-4, OX-40, CD137), and/or pazopanib
- •3. Any unresolved toxicity NCI CTCAE Grade =2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
- •4. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.
- •5. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.
- •6. A WOCBP who has a positive urine pregnancy test within 72 hours prior to randomization. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- •7. Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (=2 weeks of radiotherapy) to non-CNS disease.
- •8. Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
- •9. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
- •10. Known additional malignancy that is progressing or has required active treatment within the past 3 years.
- •Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, urothelial cancer, or carcinoma in situ that have undergone potentially curative therapy are not excluded.
- •11. Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable: without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study intervention).
- •12. 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 treatment and is allowed.
- •13. Has a history of or current(non-infectious) pneumonitis/interstitial lung disease that required steroids
- •14. Has a known history of Human Immunodeficiency Virus (HIV) infection.
- •Note: No HIV testing is required unless mandated by local health authority.
- •15. Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection.
- •? Note: Hepatitis B and C screening tests are not require
研究者
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