RecruitingPhase 2

Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread

United States827 participantsStarted 2018-08-13

Plain-language 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).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Received a first-line platinum-containing regimen in the metastatic setting or for inoperable locally advanced disease;
✓. Or received neo/adjuvant platinum-containing therapy for localized muscle-invasive urothelial cancer, with recurrence/progression ≤12 months following completion of therapy.

What they're measuring

Overall Response Rate (ORR) Based on Central Review by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) Criteria (Cohorts 1 to 4 and 6)

Timeframe: Up to Survival Follow-up Visit (maximum of 2 years after Safety Follow-up Visit (30 days after last dose date))

Progression free survival (PFS) Based on Central Review by RECIST 1.1 criteria (Cohort 5)

Timeframe: Up to Survival Follow-up Visit (maximum of 2 years after Safety Follow-up Visit (30 days after last dose date))

ORR Based on Investigator Review by RECIST 1.1 Criteria (Cohort 7)

Timeframe: Up to Survival Follow-up Visit (maximum of 2 years after Safety Follow-up Visit (30 days after last dose date))

Percentage of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) (Cohort 7)

Timeframe: First dose date up to last dose date plus 30 days (approximately 3 years)

Percentage of Participants Experiencing any Clinically Significant Laboratory Abnormalities (Cohort 7)

Timeframe: First dose date up to last dose date plus 30 days (approximately 3 years)

Trial details

NCT IDNCT03547973

SponsorGilead Sciences

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2030-04

Contact for this trial

Gilead Clinical Study Information Center

1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com

View on ClinicalTrials.gov More Metastatic Urothelial Cancer trials

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Received a first-line platinum-containing regimen in the metastatic setting or for inoperable locally advanced disease;
✓. Or received neo/adjuvant platinum-containing therapy for localized muscle-invasive urothelial cancer, with recurrence/progression ≤12 months following completion of therapy.