This study is for Indian adults in India who have cancer in the bladder lining (urothelial cancer). Their cancer is advanced or has spread to other parts of the body. Enfortumab vedotin is a treatment for this type of cancer.
The main aim of the study is to confirm the safety of enfortumab vedotin in Indian adults with urothelial cancer.
During the study, people will receive enfortumab vedotin. The study treatment will be given to people slowly through a tube into a vein. This is called an infusion. People will receive 3 separate infusions of enfortumab vedotin in each 28-day (4 weeks) treatment cycle.
People visit their study clinic for health-checks several times during and after they receive enfortumab vedotin.
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.
Participant must have experienced radiographic progression or relapse during or after a checkpoint inhibitor (CPI) (anti-PD-1 or anti-PD-L1) for locally advanced (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.
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 ajuvant/neoadjuvant setting, the participant must have progressed within 12 months of completion.
Participant must have measurable metastatic or LA disease at baseline according to RECIST version 1.1.
Participant has preexisting sensory or motor neuropathy grade ≥ 2.
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
Single group
Enfortumab Vedotin
DrugIntravenous infusion
Number of participants with Adverse events
Adverse events (AE) will be coded using MedDRA. An AE is defined as any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. This includes events related to the comparator, if applicable, and events related to the (study) procedures.
Number of participants with laboratory value abnormalities and/or AEs
Number of participants with potentially clinically significant laboratory values.
Number of participants with vital sign abnormalities and/or AEs
Number of participants with potentially clinically significant vital sign values.
Number of participants with electrocardiogram (ECG) abnormalities and/or AEs
Number of participants with potentially clinically significant ECG values.
Confirmed Overall Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST V1.1) per investigator assessment
ORR is defined as the proportion of participants whose best overall response is a confirmed complete response (CR) or partial response (PR) according to RECIST version 1.1 per investigator assessment
Duration of Response (DOR) according to RECIST version 1.1 per investigator assessment
DOR is defined as the time from the date of the first documented response (CR or PR that is subsequently confirmed) per RECIST version 1.1 as determined by investigator to the date of first documented radiological disease progression per RECIST version 1.1 or death, whichever occurs first.
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Astellas Pharma Global Development, Inc.
Lead sponsor
Pfizer
Collaborator
