A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2
Phase 2
372
about 7 years
18+
158 sites in AZ, CA, DC +16
What this study is about
Researchers are testing if a drug called disitamab vedotin, alone or with pembrolizumab, works to treat urothelial cancer that expresses HER2. The trial will also test how safe the drug is for participants and what side effects happen when participants get the drug.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take disitamab vedotin
- 2.Take pembrolizumab
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You are randomly assigned, but you will know your treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
pembrolizumab (Immune checkpoint inhibitor; blocks PD-1 to boost T-cell attack on cancer)
infusion
Primary: Change from baseline of left ventricular ejection fraction (LVEF) (Cohorts D and E), Confirmed Objective Response Rate (cORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1) by blinded independent central review (BICR) (Cohorts A, B, C, and G), Incidence of adverse events (AEs) (Cohorts D and E), PK parameter - Maximum concentration (Cmax) (Cohorts D and E), PK parameter - Time to maximum concentration (Tmax) (Cohorts D and E), PK parameter - Trough concentration (Ctrough) (Cohorts D and E), Pharmacokinetic (PK) parameter - Area under the curve (AUC) (Cohorts D and E)
Secondary: Change from baseline of LVEF (Cohorts A, B, C, and G), Confirmed DOR per RECIST v1.1 by investigator assessment (Cohorts A, B, C, and G), Confirmed Duration of Response (DOR) per RECIST v1.1 by BICR (Cohorts A, B, C, and G), DCR per RECIST v1.1 by investigator (Cohorts A, B, C, and G), Disease control rate (DCR) per RECIST v1.1 by BICR (Cohorts A, B, C, and G), Incidence of adverse events (AEs) (Cohorts A, B, C, and G), Overall survival (OS) (Cohorts A, B, C, and G), PFS per RECIST v1.1 by investigator assessment (Cohorts A, B, C, and G)