Health Condition 1: C689- Malignant neoplasm of urinary organ, unspecified
Conditions
Interventions
Intervention1: Enfortumab Vedotin: Solution for injection 1.25 mg/kg (maximum dose 125 mg)
Intervention Label: Enfortumab vedotin
Intervention Name: Enfortumabvedotin
Type: Drug
Pharmaceutical Dos
IMP: investigational medicinal product
NIMP: noninvestigational medicinal product.
Control Intervention1: Not applicable: Not applicable
Sponsors
Astellas Pharma Global Development Inc.
KlinEra Global Services
Eligibility
Inclusion criteria
Inclusion criteria: Age 1. Participant is more than or equal to 18 years of age at the time of signing the ICF. Type of Participant and Disease Characteristics 2. Participant has histologically or cytologically confirmed urothelial carcinoma (i.e., cancer of the bladder, renal pelvis, ureter or urethra). Participants with urothelial carcinoma (transitional cell) with squamous differentiation or mixed cell types are eligible. 3. Participant must have experienced radiographic progression or relapse during or after a CPI (anti-PD-1 or anti-PD-L1) for LA or metastatic disease. Participants who discontinued CPI treatment due to toxicity are eligible provided that they have evidence of disease progression following discontinuation. The CPI need not be the most recent therapy. Participants for whom the most recent therapy has been a non-CPI based regimen are eligible if they have progressed/relapsed during or after their most recent therapy. LA disease must not be amenable to resection with curative intent per the treating physician. 4. Participant must have received a platinum-containing regimen (cisplatin or carboplatin) in the metastatic/LA, neoadjuvant or adjuvant setting. If platinum was administered in the adjuvant/neoadjuvant setting, the participant must have progressed within 12 months of completion. 5. Participant must have measurable metastatic or LA disease at baseline according to RECIST version 1.1. 6. Participant has ECOG performance status of 0 or 1. 7. Participant has the following baseline laboratory data - - ANC more than or equal to 1500/cubic mm - Platelet count more than or equal to 100000000000/L - Hemoglobin more than or equal to 9 g/dL - CrCl more than or equal to 30 mL/min as estimated per institutional standards or as measured by 24-hour urine collection (GFR can also be used instead of CrCl) - ALT and AST less than or equal to 2.5 ULN or less than or equal to 3 ULN for participants with liver metastases. 8. Female participant: Not pregnant (see [Section 10.2]) and at least 1 of the following conditions apply: a. Not a WOCBP (see [Section 10.2]) b. WOCBP who has a negative urine or serum pregnancy test at screening or within 7 days prior to day 1 and agrees to follow the contraceptive guidance (see [Section 10.2]) from the time of informed consent through at least 6 months after final study intervention administration. Must not be breastfeeding or lactating starting at screening and throughout the investigational period and for approximately 6 months after final study intervention administration. Must not donate ova starting at first administration of study intervention and throughout the investigational period and for 6 months after final study intervention administration. 9. Male participant: Must agree to use contraception (see [Section 10.2]) with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 6 months after final study intervention administration. Must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 6 months after final study intervention administration. Must not donate sperm during the treatment period and for 6 months after final study intervention administrat
Exclusion criteria
Exclusion criteria: Medical Conditions 1. Participant has preexisting sensory or motor neuropathy grade more than or equal to 2. 2. Participant has active CNS metastases. Participant with treated CNS metastases is permitted on study if all the following are true: - CNS metastases have been clinically stable for at least 6 weeks prior to screening - If requiring steroid treatment for CNS metastases, the participant is on a stable dose less than or equal to 20 mg/day of prednisone or equivalent for at least 2 weeks - Baseline scans show no evidence of new or enlarged brain metastasis - Participant does not have leptomeningeal disease 3. Participant has ongoing clinically significant toxicity (grade 2 or higher with the exception of alopecia) associated with prior treatment (including systemic therapy, radiotherapy or surgery). - Participant with less than or equal to grade 2 immunotherapy-related hypothyroidism or panhypopituitarism may be enrolled when well-maintained/controlled on a stable dose of HRT (if indicated). - Participant with ongoing more than or equal to grade 3 immunotherapy-related hypothyroidism or panhypopituitarism are excluded. Participant with ongoing immunotherapy-related colitis, uveitis, myocarditis or pneumonitis, or participant with other immunotherapy-related AEs requiring high doses of steroids (more than 20 mg/day of prednisone or equivalent) are excluded. 4. Participant has history of another malignancy within 3 years before the first dose of study intervention or any evidence of residual disease from a previously diagnosed malignancy. - Participant with non-melanoma skin cancer, localized prostate cancer treated with curative intent with no evidence of progression, low-risk or very low-risk (per standard guidelines) localized prostate cancer under active surveillance/watchful waiting without intent to treat, or carcinoma in situ of any type (if complete resection was performed) are allowed. 5. Participant with a positive hepatitis B surface antigen and/or anti-hepatitis B core antibody and a negative polymerase chain reaction assay at baseline should receive appropriate antiviral prophylaxis or regular surveillance monitoring as per local or institutional guidelines. 6. Participant has active hepatitis C infection or known human immunodeficiency virus infection. Participant who has been treated for hepatitis C infection is permitted if they have documented sustained virologic response of more than or equal to 12 weeks. 7. Participant has 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 New York Heart Association Class III to IV within 6 months prior to the first dose of study intervention administration. 8. Participant has known active keratitis or corneal ulcerations. Participant with superficial punctate keratitis is allowed if the disorder is being adequately treated in the opinion of the investigator. 9. Participant has other underlying medical condition that, in the opinion of the investigator, would impair the ability of the participant to receive or tolerate the planned treatment and follow-up. 10. Participant has history of uncontrolled diabetes mellitus within 3 months of the fir
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of EV in adult Indian participants with LA or mUCTimepoint: Every 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the anti-tumor activity of EV as determined by investigator assessmentTimepoint: Every 8 weeks | — |
Countries
India
Contacts
Public ContactAmit Matere
Astellas Pharma Canada Inc
Outcome results
None listed