CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 827 target
Drug / intervention
Sacituzumab Govitecan-hziy +8 moredrug
Likely dose
Not stated in record
Key inclusion· 15
  • Age ≥18 years (≥19 in South Korea)
  • ECOG performance status 0 or 1
  • Adequate renal and hepatic function
  • Adequate hematologic parameters without transfusional support
Key exclusion· 17
  • Pregnant or lactating females
  • Prior anti-cancer monoclonal antibody within 4 weeks of Day 1 or unrecovered adverse events from earlier agents
  • Active second malignancy
  • Known active Hepatitis B or Hepatitis C

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03547973
NCT03547973Phase 2RecruitingHigh MomentumUpdated 3mo ago
Long Recruiting

A Phase II Open-Label Study of Sacituzumab Govitecan in Unresectable Locally Advanced/Metastatic Urothelial Cancer

Gilead Sciences·interventional·Posted Jun 6, 2018·Updated Mar 16, 2026

In Brief

A Phase 2 clinical trial evaluating Sacituzumab Govitecan-hziy, Pembrolizumab, and 7 other interventions for Metastatic Urothelial Cancer. Currently recruiting, targeting 827 participants across 135 sites in 9 countries.

Signals

Enrolling ahead of pace

Detailed Summary

The objective of this study is to evaluate the efficacy and safety of sacituzumab govitecan-hziy monotherapy and with novel combinations in participants with metastatic urothelial cancer (mUC).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance, Germany, Greece, Italy, South Korea, Spain, Turkey (Türkiye), United Kingdom, United States

Timeline

Phase 2Recruiting
201920202021202220232024202520262027202820292030
First PostedJun 6, 2018
Enrollment StartAug 13, 2018
Primary CompletionApr 1, 2030
TodayJul 2, 2026
Enrollment to primary: 11.6 yearsPosted 8.1 years agoPrimary completion in 3.7 years

Interventions

Sacituzumab Govitecan-hziydrug

Administered intravenously.

Pembrolizumabdrug

Administered per package insert

Cisplatindrug

Administered per package insert

Avelumabdrug

Administered per package insert

Zimberelimabdrug

Administered intravenously

Carboplatindrug

Administered per package insert

Gemcitabinedrug

Administered per package insert

Domvanalimabdrug

Administered intravenously

Enfortumab Vedotindrug

Administered intravenously