Combinations of Sacituzumab Govitecan Plus Enfortumab Vedotin and Pembrolizumab for Metastatic Urothelial Carcinoma: the Double Antibody Drug Conjugate (DAD) and Double Antibody Drug Conjugate With Immunotherapy (DAD-IO) Phase I/II Trial
Dana-Farber Cancer Institute
Summary
Phase I of this research study will assess what doses of Sacituzumab Govitecan and Enfortumab Vedotin can be safely combined in the treatment of metastatic urothelial carcinoma (mUC). In Phase II of the study, patients in one of the two cohorts will receive Sacituzumab Govitecan, Enfortumab Vedotin, and Pembrolizumab to assess the efficacy of this drug combination. The names of the study drugs in these investigational combinations are: * Enfortumab Vedotin * Sacituzumab Govitecan * Pembrolizumab
Description
Phase I of this study was a single-center, open-label, nonrandomized phase I trial testing the safety and efficacy as well as defining the appropriate dose for future studies of Sacituzumab Govitecan and Enfortumab for people with metastatic urothelial carcinoma (mUC) progressing on platinum-based chemotherapy and PD1/L1 inhibitors. The U.S. Food and Drug Administration (FDA) has approved Enfortumab Vedotin for the treatment of metastatic urothelial carcinoma (mUC) (bladder cancer). The FDA has not approved Sacituzumab Govitecan for metastatic urothelial carcinoma (mUC) (bladder cancer) but i…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Phase II Study Cohort A (dose expansion study to assess efficacy of Sacituzumab Govitecan (SG) and Enfortumab vedotin-ejfv (EV) combination) Inclusion Criteria: * Participants must have histologically documented confirmed predominant urothelial carcinoma (i.e. of the bladder, renal pelvis, ureter or urethra). Patients with squamous differentiation or mixed cell types are eligible if the urothelial component is more than 50%; small-cell carcinoma is not allowed. Patients with locally advanced unresectable disease are eligible. * Patient who are cisplatin eligible must have received prior trea…
Interventions
- DrugSacituzumab Govitecan (SG)
Intravenous infusion
- DrugEnfortumab vedotin-ejfv (EV)
Intravenous infusion
- DrugPembrolizumab
Intravenous infusion
Location
- Dana Farber Cancer InstituteBoston, Massachusetts