Sacituzumab Govitecan Plus EV in Metastatic UC

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

Trial Details

NCT ID
NCT04724018
Phase
PHASE1 / PHASE2
Sponsor
Dana-Farber Cancer Institute
Status
RECRUITING
Cancer Type
Urothelial Carcinoma Bladder Cancer
Interventions
  • Sacituzumab Govitecan (SG)
  • Enfortumab vedotin-ejfv (EV)
  • Pembrolizumab
Locations (sample)
  • Boston, Massachusetts, United States|42.35843,-71.05977

Key Eligibility Criteria

  • Participants must have histologically documented confirmed predominant urothelial carcinoma (i.e. of the bladder, renal pelvis, ureter or urethra).…
  • Patient who are cisplatin eligible must have received prior treatment with platinum containing therapy defined as within the adjuvant/neoadjuvant s…
  • Patients who are cisplatin-ineligible need only have progressed on or since one line of therapy defined as therapy given in the adjuvant/neoadjuvan…
  • Patient must be progressing on or since most recent therapy

For full eligibility, visit ClinicalTrials.gov.

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