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Title:
A single-arm, open-label, multicenter study of enfortumab vedotin (ASG-22CE) for treatment of patients with locally advanced or metastatic urothelial cancer who previously received immune checkpoint inhibitor (CPI) therapy (sponsor protocol #SGN22E-001)
Protocol Number:
J1797
Phase:
Phase II
Physician:
Noah Hahn
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
Patient population must have locally advanced or metastatic urothelial cancer who previously received therapy with Check point inhibitors with measurable disease. Patients must have prior treatment with platinum-containing chemotherapy or be ineligible for treatment with cisplatin at time of enrollment.
Eligibility:
Eligibility Criteria:1.Must have histologically or cytological documented locally advanced or metastatic transitional cell carcinoma of the urothelium (cancer of the bladder, renal pelvis, ureter, or urethra). Squamous differentiation or mixed cell types are eligible. 2.Must have received prior immunotherapy treatment defined as a PD-1 inhibitor or PD-L1 inhibitor (including, but not limited to: Atezolizumab, pembrolizumab, durvalumab, avelumab, and nivolumab). 3.Must have prior treatment with platinum-containing chemotherapy or be ineligible for treatment with cisplatin at time of enrollment due to one of the following: impaired renal function, or a hearing loss of 25 decibels (dB) at two contiguous frequencies. If platinum was administered in the adjuvant/neoadjuvant setting must have progressed within 12 months of completion.4.Must have measurable disease. Lesions in a prior radiation field must have progressed subsequent to radiotherapy to be considered measurable. 5.The following baseline laboratory data, assessed locally (no transfusions are permitted within 2 weeks prior to screening): a.absolute neutrophil count (ANC) equal to 1.0 × 109/Lb.platelet count equal to 100 × 109/Lc.hemoglobin equal to 9 g/dLd.serum bilirubin equal to 1.5 × upper limit of normal (ULN) or equal to 3 × ULN for patients with Gilbert’s diseasee.CrCl equal to 30 mL/min as estimated by the Cockcroft-Gault criteriaf.alanine aminotransferase (ALT) and aspartate aminotransferase (AST) equal to 3 × ULN6.If childbearing potential or partner is of child bearing potential use a condom in addition to another approved form of birth control from screening, study period and for at least 6 months after the last dose of study drug.7.Females 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 study drug administration. 8.Males must not donate sperm starting at screening and throughout the study period, and for at least 6 months after the final study drug administration.Exclusion Criteria:1.Active central nervous system (CNS) metastases. Treated CNS metastases are permitted on study if all the following are true: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 metastasisb.If requiring steroid treatment for CNS metastases, the patient is on a stable dose equal to 20 mg/day of prednisone or equivalent for at least 2 weeksc.Does not have leptomeningeal disease2.Ongoing clinically significant toxicity (Grade 2 or higher) associated with prior treatment (including systemic therapy, radiotherapy or surgery). Patients with hypothyroidism or panhypopituitarism related to treatment with PD-1 and PD-L1 inhibitors may be enrolled. Hormone replacement therapy may be enrolled if on a stable dose. Immunotherapy related colitis, uveitis, or pneumonitis are excluded. Other immunotherapy related adverse events requiring high doses of steroids ( greater than 20 mg/day of prednisone or equivalent) are excluded. 3.Prior treatment with Enfortumab vedotin or other MMAE-based ADCs. 4.History of another malignancy within 3 years or any evidence of residual disease from a previously diagnosed malignancy. Non-melanoma skin cancer, localized prostate cancer treated with curative intent with no evidence of progression, low-risk or very low-risk localized prostate cancer under active surveillance without intent to treat, or resected carcinoma in situ of any type are allowed.5.Receiving systemic antimicrobial treatment for active infection (viral, bacterial, or fungal). Routine antimicrobial prophylaxis is permitted. 6.Positive hepatitis B surface antigen and/or anti-hepatitis B core antibody. Negative polymerase chain reaction (PCR) assay are permitted with appropriate antiviral prophylaxis. Active hepatitis C infection or known human immunodeficiency virus (HIV) infection. Previously treated for hepatitis C infection are permitted if they have documented sustained virologic response of equal to 12 weeks. 7.Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms within 6 months prior to treatment Radiotherapy or major surgery within 2 weeks prior to first dose of study drug.8.Chemotherapy, biologics, investigational agents, and/or antitumor treatment with immunotherapy that is not completed 2 weeks prior to first dose of study drug.9.Known hypersensitivity to Enfortumab vedotin or to any excipient contained in the drug formulation of Enfortumab vedotin (including histidine, trehalose dihydrate, and polysorbate 20).10.Patients with active keratitis or corneal ulcerations.11.Other underlying medical condition that, in the opinion of the investigator, would impair the ability of the patient to receive or tolerate the planned treatment and follow-up.
Treatment:
Cycles are 28 days in lengthWeekly infusions on weeks 1-3 of each cycleAdditional visits for study blood work and monitoring
Population:
Adult
Last Update
03/05/2019 05:03 AM