EUCTR2018-001527-39-IT进行中（未招募）1 期
A study of enfortumab vedotin (ASG-22CE) as monotherapy or in combination with other anticancer therapies for the treatment of urothelial cancer -
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- SEAGEN INC.
- 入组人数
- 150
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
- All
入选标准
- •1.Patients must have histologically documented locally advanced or metastatic urothelial (previously known as transitional cell) cancer (ie,
- •cancer of the bladder, renal pelvis, ureter, or urethra). Patients with squamous differentiation or mixed cell types are eligible. Patients with
- •locally advanced disease that is resectable with curative intent are ineligible.
- •2.Patients in Cohort K must be eligible for CPI therapy.
- •3. Cohort-specific eligibility:
- •Randomized Cohort K (EV Mono arm and EV+Pembro arm): Patients must be ineligible for cisplatin-based chemotherapy at the time of
- •enrollment due to at least 1 of the following criteria:
- •i. Glomerular filtration rate (GFR) <60 mL/min but =30 mL/min (measured by the Cockcroft-Gault formula, modification of diet in renal
- •disease [MDRD] or 24-hour urine)
- •ii. ECOG performance status of <= 2 (refer to inclusion criterion #6 for additional criteria for subjects with ECOG 2)
- •iii. NCI CTCAE Version 4.03 Grade > = 2 hearing loss
- •iv. NYHA Class III heart failure
- •Patients must not have received prior systemic treatment for locally advanced or metastatic disease. Patients may not have previously
- •received adjuvant/neoadjuvant platinum-based therapy within 12 months prior to randomization.
- •4. Minimum age of 18 years
- •5. Patients must have measurable disease according to RECIST Version 1.1 (Eisenhauer 2009). Lesions in a prior irradiated field must have
- •progressed to be considered measurable.
- •6. An ECOG performance status of 0, 1, or 2 .
- •Subjects with ECOG performance status of 2 must additionally meet the following criteria:
- •i. Hemoglobin > = 10 g/dL
- •ii. GFR > = 50 mL/min
- •iii. May not have NYHA Class III heart failure
- •7. Anticipated life expectancy of > = 3 months as assessed by the investigator.
- •8. Have adequate organ function as defined in the following table.
- •Specimens must be collected within 7 days prior to the start of study treatment.
- •9. A female subject of childbearing potential is anyone born female who has experienced menarche and who has not undergone surgical
- •sterilization (eg, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or has not completed menopause. Menopause is defined clinically as 12 months of amenorrhea in a person over age 45 in the absence of other biological, physiological, or pharmacological causes. Female subjects of childbearing potential must meet the following conditions:
- •Agree not to try to become pregnant during the study and for at least 6 months after the final dose of study drug.
- •Must have a negative urine or serum pregnancy test (minimum sensitivity of 25 mIU/mL or equivalent units of beta human chorionic
- •gonadotropin [ß-hCG]) within 3 days prior to Day 1. Female subjects with false positive results and documented verification of negative
- •pregnancy status are eligible for participation.
- •If heterosexually active, must consistently use highly effective methods of birth control, with a failure rate of less than 1% starting at
- •screening, throughout the study period, and for at least 6 months after the final dose of study drug.
- •Female subjects must agree not to breastfeed or donate ova starting at screening and throughout the study period, and for at least 6 months
- •after the final dose of study drug.
- •10. A male subject who can father children is anyone born male who has testes and who has not undergone surgical sterilization (eg, vasectomy followed by a clinical test proving that the procedure was effective). Male subjects who can father children,
排除标准
- •1. Received any prior treatment with a CPI. A CPI is defined as a PD-1 inhibitor, PD-L1 inhibitor, or PD-L2 inhibitor (including, but not limited
- •to, atezolizumab, pembrolizumab, nivolumab, durvalumab, or avelumab). Patients in Expansion Cohort F may have previously received treatment with a CPI.
- •2. Received any prior treatment with an agent directed to another stimulatory or co-inhibitory T-cell receptor (including but not limited to
- •CD137 agonists, CTLA-4 inhibitors, or OX-40 agonists).
- •3. Ongoing sensory or motor neuropathy Grade 2 or higher.
- •4. Active central nervous system [CNS] metastases. Patients with treated CNS metastases are permitted on study if all the following are
- •a. CNS metastases have been clinically stable for at least 6 weeks prior to screening and baseline scans show no evidence of new or enlarged
- •metastasis.
- •b. If requiring steroid treatment for CNS metastases, the patient is on a stable dose <10 mg/day of prednisone or equivalent for at least 2
- •c. Patient does not have leptomeningeal disease.
- •5. Ongoing clinically significant toxicity (Grade 2 or greater) associated with prior treatment (including radiotherapy or surgery).
- •6. Patients with conditions requiring high doses of steroids (>10 mg/day of prednisone or equivalent) or other immunosuppressive medications
- •are excluded. Inhaled or topical steroids are permitted in the absence of active autoimmune disease.
- •7. Prior treatment with enfortumab vedotin or other MMAE-based ADCs for urothelial cancer.
- •8. History of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously
- •diagnosed malignancy. Patients with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ (eg, breast carcinoma,
- •cervical cancer) who have undergone potentially curative therapy are not excluded. Patients with low-risk prostate cancer (T1-T2a, Gleason
- •score =6, and prostate specific antigen [PSA] <10 ng/mL) either treated with definite intent any time prior to screening or untreated in active
- •surveillance are not excluded.
- •9. Currently receiving systemic antimicrobial treatment for active infection (viral, bacterial, or fungal) at the time of first dose of
- •enfortumab vedotin. Routine antimicrobial prophylaxis is permitted.
- •10. Patients with a positive hepatitis B surface antigen and/or antihepatitis B core antibody; patients with a negative polymerase chain
- •reaction (PCR) assay are permitted with either universal prophylaxis or the use of a pre-emptive approach. The approach will be selected in accordance with regional or national guidelines for patients who receive anticancer therapies.
- •11. Active hepatitis C infection or known human immunodeficiency virus (HIV) infection. Patients who have been curatively treated for hepatitis C
- •infection are permitted if they have documented sustained virologic response of 12 weeks. No HIV testing is required unless mandated by local health authority.
- •12. Patients with active tuberculosis.
- •13. Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac
- •symptoms (including congestive heart failure) consistent with NYHA Class III–IV (see Appendix E) within 6 months prior to the first dose of
- •enfortumab vedotin. Patients with NYHA Class III are permitted in Cohort K.
- •14. Radiotherapy or major surgery within 2 weeks prior to first dose of study drug. Patient must have recovered adequ
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