Study on Sacituzumab Govitecan and Enfortumab Vedotin for Treating Advanced Bladder Cancer

Sponsor: Dana-Farber Cancer Institute

Sponsor score: 40

ClinicalTrials ID:NCT04724018

Provider View

This clinical trial is exploring the safety and effectiveness of combining two drugs, Sacituzumab Govitecan and Enfortumab Vedotin, for treating advanced bladder cancer. The study will also test if adding a third drug, Pembrolizumab, improves treatment outcomes.

Patient Parameters

Program Overview

The study aims to find the safest doses of Sacituzumab Govitecan and Enfortumab Vedotin when used together to treat advanced bladder cancer. In the second phase, researchers will test how well these drugs work when combined with Pembrolizumab in patients who have not received prior treatment for their cancer.

Description

This study is divided into two phases. In Phase I, researchers will determine the safest doses of Sacituzumab Govitecan and Enfortumab Vedotin for patients with advanced bladder cancer that has worsened despite previous treatments. The goal is to find a combination that controls the cancer effectively without causing serious side effects. Once the best dose is found, Phase II will begin.

In Phase II, the study will test how well the combination of Sacituzumab Govitecan and Enfortumab Vedotin works in patients whose cancer has not responded to other treatments. Another group of patients will receive these two drugs along with Pembrolizumab to see if this combination is more effective.

Participants will undergo screening to ensure they meet the study criteria, receive the study treatment, and have follow-up visits to monitor their health and the treatment's effects. The study is supported by Gilead, a pharmaceutical company, which provides funding and the study drug Sacituzumab Govitecan.

Up to 24 people will participate in Phase I, and up to 41 people in each of the two groups in Phase II.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of advanced bladder cancer, including cancer of the bladder, renal pelvis, ureter, or urethra.
  • Cancer must have worsened after previous treatments, including platinum-based chemotherapy and PD1/L1 inhibitors.
  • Must be 18 years or older.
  • Must be in good overall health with a performance status score of 0 or 1.
  • Must have adequate organ and bone marrow function, as shown by specific blood tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for six months after.
  • Men must agree to use effective birth control during the study and for four months after.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Women who are pregnant or breastfeeding.
  • Have received certain cancer treatments within a specified time before starting the study.
  • Have unresolved side effects from previous cancer treatments.
  • Have an active second cancer, except for certain low-risk cancers.
  • Have active brain metastases or cancer in the brain lining.
  • Have serious heart conditions or recent heart attacks.
  • Have active inflammatory bowel disease or recent gastrointestinal perforation.
  • Have serious infections requiring antibiotics.
  • Have uncontrolled diabetes or other serious medical conditions.
  • Have a history of severe allergic reactions to similar drugs.
  • Are taking other investigational drugs or treatments.

Locations

FACILITYZIPCITYSTATE
Dana Farber Cancer Institute02215BostonMassachusetts

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