An Expanded Access Treatment Protocol of Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Urothelial Carcinoma

Inclusion Criteria

• •Subject has locally advanced or metastatic urothelial carcinoma (UC) and has progressed during or after the most recent therapy.
• •Subject has previously received a platinum containing regimen (i.e., cisplatin or carboplatin) in the metastatic/locally advanced or neoadjuvant/adjuvant setting.
• •* If the platinum containing regimen was administered in the adjuvant/neoadjuvant setting, progression on or after this treatment must be ≤ 12 months after treatment completion.
• •Subject has previously received treatment with a programmed cell death protein 1 (PD-1) inhibitor or programmed death-ligand 1 (PD-L1) inhibitor (including, but not limited to, atezolizumab, pembrolizumab, durvalumab, avelumab and nivolumab) in the metastatic/locally advanced setting.
• •* Subject treated with a PD-1 or PD-L1 inhibitor in the neoadjuvant/adjuvant setting and had recurrent or progressive disease either during therapy or ≤ 3 months of therapy completion may be enrolled.
• •Subject has exhausted available standard of care therapies for locally advanced or metastatic UC.
• •* Subject may have had any number of prior lines of therapy for locally advanced or metastatic UC.
• •Subject has the following baseline laboratory data:
• •* absolute neutrophil count ≥ 1500/mm3
• •* platelet count ≥ 75 x 109/L
• •* hemoglobin ≥ 8 g/dL
• •* serum bilirubin ≤ 1.5 x upper limit of normal (ULN) or ≤ 3 x ULN for subjects with Gilbert's disease
• •* creatinine clearance (CrCl) ≥ 15 mL/min or ≥ 30 mL/min for subjects with Eastern Cooperative Oncology Group (ECOG) performance status of 2 as estimated per institutional standards or as measured by 24 hour urine collection (glomerular filtration rate can also be used instead of CrCl)
• •* alanine aminotransferase and aspartate aminotransferase ≤ 2.5 x ULN or ≤ 3 x ULN for subjects with liver metastases
• •Subject has ECOG performance status of 0, 1 or 2.
• •Female subject is not pregnant and at least 1of the following conditions apply:
• •* not a woman of childbearing potential (WOCBP), or
• •* a WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 6 months after final protocol treatment administration.
• •Female subject must agree not to breastfeed starting at screening and throughout the treatment protocol period and for 6 months after final protocol treatment administration.
• •Female subject must not donate ova starting at first dose of investigational product (IP) and throughout the treatment protocol period and for 6 months after final protocol treatment administration.
• •Male subject with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception throughout the treatment period and for 6 months after final protocol treatment administration.
• •Male subject must not donate sperm during the treatment period and for 6 months after final protocol treatment administration.
• •Male subject with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the treatment protocol period and for 6 months after final protocol treatment administration.
• •Subject agrees not to participate in another interventional study while receiving treatment in the present treatment protocol.