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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Intravenous infusion
Site IN91013
Patna, Bihar, India
RECRUITINGSite IN91015
Kochi, Kerala, India
RECRUITINGSite IN91004
Mumbai, Maharashtra, India
RECRUITINGSite IN91016
New Delhi, National Capital Territory of Delhi, India
RECRUITINGSite IN91017
Dumas, Surat, India
RECRUITINGSite IN91007
Vellore, Tamil Nadu, India
RECRUITINGSite IN91005
Varanasi, Uttar Pradesh, India
RECRUITINGSite IN91006
Kolkata, West Bengal, India
RECRUITINGSite IN91012
Ahmedabad, India
RECRUITINGSite IN91010
Bhubaneswar, India
RECRUITING...and 5 more locations
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.
Time frame: Up to 8 months
Number of participants with laboratory value abnormalities and/or AEs
Number of participants with potentially clinically significant laboratory values.
Time frame: Up to 7 months
Number of participants with vital sign abnormalities and/or AEs
Number of participants with potentially clinically significant vital sign values.
Time frame: Up to 7 months
Number of participants with electrocardiogram (ECG) abnormalities and/or AEs
Number of participants with potentially clinically significant ECG values.
Time frame: Up to 6.5 months
Number of Participants at each grade of Eastern Cooperative Oncology Group (ECOG) Performance Status score
The ECOG scale will be used to assess performance status. Scores range from 0 (fully active) to 5 (dead). Negative change scores indicate an improvement. Positive scores indicate a decline in performance.
Time frame: Up to 7 months
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
Time frame: Up to 34 months
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.
Time frame: Up to 34 months
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