A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2

No strong warning signs right now. The score counts warning signs; it is not a prediction.

Why this score

Score over time

What counts as success

The trial's main goal(s), called the “primary outcome.”

• 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)

  Measured over: Duration of treatment; approximately 2 years

• Incidence of adverse events (AEs) (Cohorts D and E)

  Measured over: Approximately 2 years

• Incidence of dose alterations (Cohorts D and E)

  Measured over: Approximately 2 years

• Incidence of laboratory abnormalities (Cohorts D and E)

  Measured over: Approximately 2 years

• Incidence of electrocardiogram (ECG) abnormalities (Cohorts D and E)

  Measured over: Approximately 2 years

• Change from baseline of left ventricular ejection fraction (LVEF) (Cohorts D and E)

  Measured over: Approximately 2 years

• Pharmacokinetic (PK) parameter - Area under the curve (AUC) (Cohorts D and E)

  Measured over: Through 30-37 days following the last dose of DV; up to approximately 2 years

• PK parameter - Maximum concentration (Cmax) (Cohorts D and E)

  Measured over: Through 30-37 days following the last dose of DV; up to approximately 2 years

• PK parameter - Time to maximum concentration (Tmax) (Cohorts D and E)

  Measured over: Through 30-37 days following the last dose of DV; up to approximately 2 years

• PK parameter - Trough concentration (Ctrough) (Cohorts D and E)

  Measured over: Through 30-37 days following the last dose of DV; up to approximately 2 years

Changes Tremor has spotted