RecruitingPhase 1Phase 2NCT04724018

Sacituzumab Govitecan Plus EV in Metastatic UC

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


Sponsor

Dana-Farber Cancer Institute

Enrollment

106 participants

Start Date

May 20, 2021

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two targeted antibody-drug therapies — sacituzumab govitecan and enfortumab vedotin — with or without the immunotherapy drug pembrolizumab, for patients with advanced bladder or urinary tract cancer (called urothelial carcinoma) that has stopped responding to prior treatments. **You may be eligible if:** - You are 18 or older with confirmed urothelial carcinoma (bladder, kidney pelvis, ureter, or urethra) - Your cancer has progressed on or after prior treatment (including platinum-based chemotherapy and/or immunotherapy) - You have measurable disease on imaging - Your organ function (kidneys, liver, blood) meets minimum standards - You are willing to use contraception during treatment and for 6 months afterward **You may NOT be eligible if:** - You are pregnant or breastfeeding - You have previously received these specific drugs (topoisomerase 1 inhibitors, sacituzumab govitecan, or enfortumab vedotin) - You have active brain metastases or carcinomatous meningitis - You have serious heart problems, active infection, active inflammatory bowel disease, or uncontrolled diabetes - You have a history of certain autoimmune diseases (for the pembrolizumab cohort) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSacituzumab Govitecan (SG)

Intravenous infusion

DRUGEnfortumab vedotin-ejfv (EV)

Intravenous infusion

DRUGPembrolizumab

Intravenous infusion


Locations(1)

Dana Farber Cancer Institute

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

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NCT04724018


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