At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed predominant urothelial carcinoma (bladder, renal pelvis, ureter, or urethra)
- ✓Urothelial component >50% if squamous differentiation or mixed cell types; small-cell carcinoma not allowed
- ✓Locally advanced unresectable disease eligible
- ✓Age ≥18 years
- ✕Pregnant or lactating women
- ✕Prior topoisomerase 1 inhibitors, SG, or EV
- ✕Active second malignancy (except completely treated or surgically-cured with low recurrence risk)
- ✕Active CNS metastases or carcinomatous meningitis (treated brain metastases allowed if stable ≥4 weeks)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Sacituzumab Govitecan (SG), Enfortumab vedotin-ejfv (EV), and 1 other intervention for Urothelial Cancer and 3 related conditions. Currently recruiting, targeting 106 participants across 1 site.
Detailed 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
Study Details
Timeline
Interventions
Intravenous infusion
Intravenous infusion
Intravenous infusion