A Randomized Phase III Study of Datopotomab-Deruxtecan (Dato-DXd) plus Carboplatin or Cisplatin versus Gemcitabine plus Carboplatin or Cisplatin in Subjects with Locally Advanced or Metastatic Urothelial Carcinoma (la/mUC) who progressed during or after Enfortumab Vedotin (EV) plus Pembrolizumab Combination Treatment. TROPIONUrothelial03 (TU03).
Categories (click each to see list of all clinical trials associated with that category): GI (ONC)
Current Status: Not open
Phase: II/III
Principal Investigator: Leuva, Harshraj
Contact Information:
Micki Bethea, BS
+1 402-559-8011
mbethea@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT07129993?term=NCT07129993&rank=1#participation-criteria
Summary
Part 1: Primary Objective: To evaluate the relative efficacy of Dato-DXd 4mg/kg plus platinum therapy and Dato-DXd 6 mg/kg plus platinum therapy as measured by ORR by investigator.
Secondary Objectives: -To further evaluate the relative efficacy of Dato-DXd 4 mg/kg plus platinum therapy and Dato-DXd 6 mg/kg plus platinum therapy. -To evaluate the relative safety and tolerability of Dato-DXd 4 mg/kg plus platinum therapy and Dato-DXd 6 mg/kg plus platinum therapy. -To assess the immunogenicity of Dato-DXd. -To evaluate the PK of Dato-DXd and DXd and exposure-response relationships for efficacy and safety.
Part 2: Primary Objective: -To compare the efficacy of Dato-DXd plus platinum therapy with gemcitabine plus platinum therapy as measured by PFS by BICR. -To compare the efficacy of Dato-DXd plus platinum therapy with gemcitabine plus platinum therapy as measured by OS.
Secondary Objective: -To further evaluate the efficacy of Dato-DXd plus platinum therapy compared with gemcitabine plus platinum therapy. -To evaluate the safety and tolerability of Dato-DXd plus platinum therapy compared with gemcitabine plus platinum therapy. -To assess the immunogenicity of Dato-DXd. -To evaluate the impact of Dato-DXd plus platinum therapy compared with gemcitabine plus platinum therapy on disease-related symptoms as measured by PRO instruments. -To evaluate the impact of Dato-DXd plus platinum therapy compared with gemcitabine plus platinum therapy on overall health as measured by PRO instruments. -To evaluate the impact of Dato-DXd plus platinum therapy compared with gemcitabine plus platinum therapy on role and physical functioning as measured by PRO instruments.