A Study to Evaluate Enfortumab Vedotin (ASG-22CE) in Chinese Participants With Locally Advanced or Metastatic Urothelial Cancer Who Previously Received Platinum-containing Chemotherapy and Programmed Cell Death Protein-1 ( PD 1) / (Programmed Death Ligand-1 (PD-L1) Inhibitor Therapy
- Conditions
- Metastatic Urothelial Cancer
- Registration Number
- NCT04995419
- Lead Sponsor
- Astellas Pharma China, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria:<br><br> - Participant has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or<br> 1.<br><br> - Participant must have histologically or cytologically documented<br> urothelial/transitional cell carcinoma of the bladder, renal pelvis, ureter or<br> urethra. Other histologies including adenocarcinoma, squamous differentiation or<br> mixed are eligible.<br><br> - Participant has locally advanced or metastatic disease that is not amenable to<br> curative intent treatment. Participants must have measurable disease at baseline<br> according to Response Evaluation Criteria in Solid Tumors (RECIST) ( Version 1.1).<br> Lesions in a prior radiation field must have progressed subsequent to radiotherapy<br> to be considered measurable.<br><br> - Participant must have received prior treatment with PD-1/PD-L1 inhibitor therapy in<br> the locally advanced or metastatic urothelial cancer setting. Participants who<br> received PD-1/PD-L1 therapy in the neoadjuvant/adjuvant setting and had recurrent or<br> progressive disease either during therapy or within 3 months of therapy completion<br> are eligible.<br><br> - Participant who received prior treatment with platinum-containing chemotherapy<br> defined as those who received platinum in the neoadjuvant/adjuvant setting and had<br> recurrent or progressive disease within 12 months of completion or received<br> treatment with platinum in the locally advanced (defined as unresectable with<br> curative intent) or metastatic setting.<br><br> - Platinum based chemotherapy may include combination use with a PD-1 or PD-L1<br> inhibitor.<br><br> - Participant has the following baseline laboratory data. If a participant has<br> received a recent blood transfusion or growth factor, the hematology tests must be<br> obtained =7 days after any growth factor and = 28 days after any blood transfusion.<br><br> - absolute neutrophil count (ANC) = 1.0 × 10^9/L<br><br> - platelet count = 100 × 10^9/L<br><br> - hemoglobin = 9 g/dL<br><br> - serum total bilirubin (TBL) = 1.5 × upper limit of normal (ULN) or = 3 × ULN<br> for participants with Gilbert's disease<br><br> - creatinine clearance (CrCl) = 30 mL/min as estimated per institutional<br> standards or as measured by 24-hour urine collection (glomerular filtration<br> rate [GFR] can also be used instead of CrCl).<br><br> - alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 3 × ULN<br><br> - Female participant is not pregnant and at least one of the following conditions<br> apply:<br><br> - Not a woman of childbearing potential (WOCBP)<br><br> - WOCBP who agrees to follow the contraceptive guidance from the time of informed<br> consent through at least 6 months after the last dose of study treatment<br> administration.<br><br> - Female participant must agree not to breastfeed starting at screening and throughout<br> the study period and for at least 6 months after the last dose of study treatment<br> administration.<br><br> - Female participant must not donate ova starting at first dose of study treatment and<br> throughout the study period and for 6 months after the last dose of study treatment<br> administration.<br><br> - Male participant with female partner(s) of childbearing potential (including<br> breastfeeding partner) must agree to use contraception throughout the treatment<br> period and for 6 months after the last dose of study treatment administration.<br><br> - Male participant must not donate sperm during the treatment period and for 6 months<br> after the last dose of study treatment administration.<br><br> - Male participant with pregnant partner(s) must agree to remain abstinent or use a<br> condom for the duration of the pregnancy throughout the study period and for 6<br> months after the last dose of study treatment administration.<br><br> - Participant agrees not to participate in another interventional study while<br> receiving study treatment in the present study.<br><br> - Participant must have had progression or recurrence of urothelial cancer during or<br> following receipt of most recent therapy.<br><br> - Participant must have an anticipated life expectancy of = 3 months.<br><br>Exclusion Criteria:<br><br> - Participant has preexisting sensory or motor neuropathy Grade = 2.<br><br> - Participant has active central nervous system (CNS) metastases. Participants with<br> treated CNS metastases are permitted on study if all the following are true:<br><br> - CNS metastases have been clinically stable for = 6 weeks prior to screening.<br><br> - If requiring steroid treatment for CNS metastases, the participant is on a<br> stable dose = 20 mg/day of prednisone or equivalent for = 2 weeks.<br><br> - Baseline imaging scans show no evidence of new or enlarged brain metastasis.<br><br> - Participant does not have leptomeningeal disease.<br><br> - Participant has ongoing clinically significant toxicity (Grade 2 or higher with the<br> exception of alopecia) associated with prior treatment (including systemic therapy,<br> radiotherapy or surgery).<br><br> - Participant with ongoing = Grade 3 immunotherapy-related hypothyroidism or<br> panhypopituitarism is excluded. Participant with ongoing immunotherapy-related<br> colitis, uveitis, myocarditis or pneumonitis, or participants with other<br> immunotherapy-related AEs requiring high doses of steroids (> 20 mg/day of<br> prednisone or equivalent), is excluded. Participant with = Grade 2<br> immunotherapy-related hypothyroidism or panhypopituitarism may be enrolled when<br> well-maintained/controlled on a stable dose of hormone replacement therapy (if<br> indicated).<br><br> - Participant has a history of uncontrolled diabetes mellitus within 3 months before<br> the first dose of study treatment. Uncontrolled diabetes is defined as hemoglobin<br> A1c (HbA1c) = 8 percent or HbA1c between 7 percent and < 8 percent with associated<br> diabetes symptoms (polyuria or polydipsia) that are not otherwise explained.<br><br> - Participant has prior treatment with enfortumab vedotin or other monomethyl<br> auristatin E (MMAE)-based antibody-drug conjugate (ADCs).<br><br> - Participant has a second malignancy diagnosed within 3 years before first dose of<br> study drug, or any evidence of residual disease from a previously diagnosed<br> malignancy. Participants with non-melanoma skin cancer, localized prostate cancer<br> treated with curative intent with no evidence of progression, low-risk or very<br> low-risk (per standard guidelines) localized prostate cancer under active<br> surveillance/watchful waiting without intent to treat, or carcinoma in situ of any<br> type (if complete resection was performed) are allowed.<br><br> - Participant is currently receiving systemic antimicrobial treatment for viral,<br> bacterial or fungal infection at the time of first dose of study treatment. Routine<br> antimicrobial prophylaxis is permitted.<br><br> - Participants with a positive hepatitis B surface antigen and/or anti-hepatitis B<br> core antibody and a negative polymerase chain reaction (PCR) assay at baseline<br> should receive appropriate antiviral prophylaxis or regular surveillance monitoring<br> as per local or institutional guidelines.<br><br> - Active hepatitis C infection or known human immunodeficiency virus (HIV) infection.<br> Participant who have been treated for hepatitis C infection are permitted if they<br>
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method