ISRCTN95561634进行中（未招募）2 期
A phase II trial of cemiplimab alone or in combination with standard of care chemotherapy in locally advanced or metastatic penile carcinoma
niversity Hospitals Bristol NHS Foundation Trust0 个研究点目标入组 47 人开始时间: 2021年3月30日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 47
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
- •1. Male >=18 years
- •2. Histologically-proven squamous cell carcinoma of the penis or penile urethra.
- •M0,Tx,N3 (i.e. involvement of pelvic lymph nodes, or extracapsular extension in a node) or;
- •M0,Tx,N2 (i.e. involvement of 3 or more ipsilateral inguinal lymph nodes, or to bilateral inguinal lymph nodes) and deemed inoperable by MDT, or;
- •M0,T3,N1 (tumour invades corpus cavernosum with/ without urethral invasion or;
- •M0,T4 (tumour invades other adjacent structures such as scrotum, prostate or pubic bone)
- •4. Performance Status ECOG 0, 1 or 2
- •5. Written, informed consent
- •6. Measurable disease as per RECIST 1.1
- •7. No previous chemotherapy for treatment of penile cancer. Patients who have had weekly cisplatin with radiotherapy (chemo-radiation) prior to advanced penile cancer diagnosis is allowed
- •8. Agree to use an adequate method of contraception for the course of the study and for at least 1 year after treatment has ended NB abstinence is acceptable if this is the usual lifestyle and preferred contraception for the participant.
- •9. Adequate organ function as evidenced by the following peripheral blood counts and serum biochemistry at enrolment:
- •Neutrophils >=1.0 x 10^9/L
- •Haemoglobin >=90 g/L
- •Platelets >=100 x 10^9/L
- •Total bilirubin <=0.5 upper limit of normal (ULN)
- •Alanine aminotransferase transaminase (ALT) <=2.5 x ULN
- •Serum creatinine <=1.5 x ULN.
排除标准
- •1. Pure veruccous carcinoma of the penis
- •2. T1 N1 M0 disease or T2 N1 M0 disease
- •3. Unfit for the trial regimen (as assessed by the multidisciplinary team)
- •4. Contraindication to chemotherapy and/or immunotherapy
- •5. Previous chemotherapy (except chemo-radiation) for penile cancer
- •6. Patients who have received radiotherapy to target lesions and have no other lesions that can act as target lesions instead (previous radiotherapy to non-target lesions is permitted)
- •7. ECOG Performance Status >2
- •8. History of an additional malignancy within 5 years of randomisation with the exception of those malignancies with a negligible risk of metastasis or death and treated with curative intent. Please confirm patient eligibility with the CI
- •9. Uncontrolled diabetes mellitus
- •10. Other concurrent serious illness or medical condition that in the investigator’s opinion precludes entry into the trial
- •11. History of severe hypersensitivity to another monoclonal antibody
- •12. History of severe hypersensitivity reaction (> = grade 3) to polysorbate 80 containing drugs
- •13. HIV, Hepatitis B or Hepatitis C infection
- •14. Active infection requiring systemic antibiotic or anti-fungal medication
- •15. Active or recent (within 5 years) systemic auto-immune disease requiring prolonged systemic steroids
- •16. Previous pneumonitis requiring systemic corticosteroid therapy
- •17. Interstitial lung disease
- •18. Receiving treatment with immunosuppressive therapy including systemic corticosteroids within 2 weeks of treatment start (Cycle 1 Day 1)
- •19. Treatment with systemic immunostimulatory agents (including, but not limited to, IFNs, IL-2) within 28 days or 5 half-lives of the drug, whichever is shorter, prior to treatment start (Cycle 1 Day 1)
- •20. Treatment with PI3K inhibitors e.g. idelalisib
- •21. Participation in another clinical trial with any investigational drug within 30 days prior to study registration
- •22. Receipt of a live virus within 28 days of randomisation
研究者
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