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Sacituzumab Govitecan Plus EV in Metastatic UC

NCT04724018 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2025-11-04

No results posted yet for this study

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

Conditions

Interventions

DRUG

Sacituzumab Govitecan (SG)

Intravenous infusion

DRUG

Enfortumab vedotin-ejfv (EV)

Intravenous infusion

DRUG

Pembrolizumab

Intravenous infusion

Sponsors & Collaborators

Principal Investigators

  • Bradley A McGregor, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-20
Primary Completion
2027-02-01
Completion
2028-05-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04724018 on ClinicalTrials.gov