ISRCTN12606219进行中（未招募）2 期
A Randomised phase II trial of Enhancement of efficacy of Atezolizumab by Radiotherapy in Metastatic urothelial carcinoma
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 102
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
- All
入选标准
- •Current inclusion criteria as of 31/07/2023:
- •1. Histologically confirmed metastatic urothelial carcinoma not amenable to curative treatment with surgery or radiotherapy. Mixed histology is permitted if predominantly TCC
- •2. Patients experiencing progressive disease (according to local investigator assessment) during up to six months of treatment with either open-label atezolizumab* (first, second or third line¥) or maintenance avelumab (following platinum-based chemotherapy); or patients with an overall best response of stable disease after a minimum of 3 cycles and a maximum of six months of open label atezolizumab
- •3. At least one extra-cranial metastatic site suitable for radiotherapy (see section 9.1)
- •4. At least one RECIST v1.1 measurable lesion distant to the planned site of radiotherapy
- •5. No radiotherapy within four weeks prior to starting pre-study atezolizumab/avelumab or during atezolizumab or avelumab treatment
- •6. Satisfactory haematological and biochemical profile (Hb >90 g/L, Plt>100 x 109/L, WBC > 3.0 x 109/L, creatinine < 1.5 ULN, AST or ALT <3X ULN, bilirubin <1.5x ULN)
- •7. ECOG PS 0-1
- •8. Age =18 years
- •9. Written informed consent
- •* In accordance with therapeutic indications as stated in the current summary of product characteristics
- •¥ Neoadjuvant treatment received more than a year prior to trial entry will not be considered a line of treatment
- •Previous inclusion criteria:
- •1. Histologically confirmed metastatic urothelial carcinoma not amenable to curative treatment with surgery or radiotherapy. Mixed histology is permitted if predominantly TCC
- •2. Received a minimum of 3 cycles and maximum of 6 cycles of open label atezolizumab treatment* (either first, second or third line¥) with an overall best response of stable disease according to local investigator assessment
- •3. At least one extra-cranial metastatic site suitable for radiotherapy
- •4. At least one additional RECIST v1.1 measurable lesion distant to planned site for radiotherapy
- •5. No radiotherapy within four weeks prior to starting pre-study atezolizumab or during atezolizumab treatment
- •6. Satisfactory haematological and biochemical profile (Hb >90 g/L, Plt>100 x 10^9/L, WBC >3.0 x 10^9/L, creatinine <1.5 ULN, AST or ALT <3X ULN, bilirubin <1.5x ULN)
- •7. ECOG PS 0-1
- •8. Age >=18 years
- •9. Written informed consent
- •* In accordance with therapeutic indications as stated in the current summary of product characteristics
- •¥ Neoadjuvant treatment received more than a year prior to trial entry will not be considered a line of treatment
排除标准
- •Current exclusion criteria as of 31/07/2023:
- •1. Any contraindication to atezolizumab treatment in the local investigator’s opinion (e.g. toxicity [see Section 9.2.8], rapidly progressive disease requiring alternative treatment such as chemotherapy)
- •2. Greater than 8 weeks since the last dose of atezolizumab or maintenance avelumab
- •3. Over 6 months’ treatment with atezolizumab or maintenance avelumab prior to randomisation
- •4. Planned or anticipated clinical need for palliative radiotherapy within 9 weeks following trial entry
- •5. Received any anti-PD1/PD-L1 or anti-CTLA-4 therapy prior to commencement of atezolizumab or maintenance avelumab
- •6. Received atezolizumab in combination with chemotherapy
- •7. Immunosuppressive treatment (apart from corticosteroids at a dose equivalent of prednisolone =10 mg daily) within 2 weeks prior to randomisation.
- •8. Contraindication to radiotherapy (e.g. radiation sensitivity syndrome)
- •9. Autoimmune disease requiring active immunotherapy treatment or with life-threatening complications. Patients with vitiligo, controlled psoriasis, autoimmune thyroid disease, type 1 diabetes will be eligible
- •10. History of pneumonitis
- •11. Presence of known active brain metastases (brain metastases which have received treatment and are controlled do not preclude randomisation)
- •12. Active HIV, hepatitis B or hepatitis C infection – patients with asymptomatic or controlled disease may join the trial following review and approval by the Chief Investigator. Participants with these conditions, either active or previous, are not eligible to provide samples for the translational substudy
- •13. Pregnant or lactating women
- •14. Administration of a live, attenuated vaccine within 28 days prior to study entry
- •15. Anticipated life expectancy <10 weeks
- •Previous exclusion criteria:
- •1. Any contraindication to continued atezolizumab treatment in the local investigator’s opinion (e.g. toxicity, rapidly progressive disease requiring alternative treatment such as chemotherapy)
- •2. Received anti-PD1/PD-L1, anti-CTLA-4 therapy prior to commencement of atezolizumab
- •3. Received atezolizumab in combination with chemotherapy
- •4. Immunosuppressive treatment (apart from corticosteroids at a dose equivalent of prednisolone <=10mg daily) within 2 weeks prior to study entry
- •5. Contraindication to radiotherapy (e.g. radiation sensitivity syndrome)
- •6. Autoimmune disease requiring active immunotherapy treatment or with life-threatening complications. Patients with vitiligo, controlled psoriasis, autoimmune thyroid disease, and type 1 diabetes will be eligible.
- •7. History of pneumonitis
- •8. Presence of known active brain metastases (brain metastases which have received treatment and are controlled do not preclude trial entry)
- •9. Active HIV, hepatitis B or hepatitis C infection – patients with asymptomatic or controlled disease may join the trial following review and approval by the Chief Investigator
- •10. Pregnant or lactating women
- •11. Administration of a live, attenuated vaccine within 28 days prior to study entry
- •12. Anticipated life expectancy <10 weeks
研究者
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