A Safety Study of Enfortumab Vedotin in Indian Adults With Urothelial Cancer

Exclusion Criteria

• •Participant has preexisting sensory or motor neuropathy grade ≥ 2.
• •Participant has active central nervous system (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 ≤ 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
• •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 ≤ grade 2 immunotherapy-related hypothyroidism or panhypopituitarism may be enrolled when well-maintained / controlled on a stable dose of hormone replacement therapy (HRT) (if indicated).
• •* Participant with ongoing ≥ 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 (\> 20 mg/day of prednisone or equivalent) are excluded.
• •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.
• •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.
• •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 ≥ 12 weeks.
• •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.
• •Participant has known active keratitis or corneal ulcerations. Participant with superficial punctate keratitis is allowed if the disorder is being adequately treated.
• •Participant has other underlying medical condition that would impair the ability of the participant to receive or tolerate the planned treatment and follow-up.
• •Participant has history of uncontrolled diabetes mellitus within 3 months of the first dose of study intervention. Uncontrolled diabetes is defined as HbA1c ≥ 8 percent or HbA1c between 7 percent and \< 8 percent with associated diabetes symptoms (polyuria or polydipsia) that are not otherwise explained.
• •Participant has prior treatment with enfortumab vedotin or other monomethyl auristatin E (MMAE)-based antibody drug conjugate (ADCs).
• •Participant is currently receiving systemic antimicrobial treatment for viral, bacterial, or fungal infection at the time of first dose of enfortumab vedotin. Routine antimicrobial prophylaxis is permitted.
• •Participant has radiotherapy or major surgery within 4 weeks prior to first dose study intervention administration.
• •Participant has had chemotherapy, biologics, investigational agents, and/or antitumor treatment with immunotherapy that is not completed 2 weeks prior to first dose of study intervention administration.
• •Participant has any condition which makes the participant unsuitable for study participation.
• •Participant has a known or suspected hypersensitivity to enfortumab vedotin or to any excipient contained in the drug formulation of enfortumab vedotin (including histidine, trehalose dihydrate, and polysorbate 20); OR participant has known hypersensitivity to biopharmaceuticals produced in CHO cells.