Study on Sacituzumab Govitecan for Urothelial Cancer That Cannot Be Removed or Has Spread

Sponsor: Gilead Sciences

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT03547973

Provider View

This clinical trial is testing the effectiveness and safety of the drug sacituzumab govitecan, alone and in combination with other treatments, for patients with urothelial cancer that has spread or cannot be surgically removed.

Patient Parameters

Program Overview

The aim of this study is to see how well sacituzumab govitecan works and how safe it is for patients with urothelial cancer that has spread to other parts of the body or cannot be removed by surgery. The study will test the drug on its own and in new combinations to find the best treatment options for these patients.

Description

The study includes different groups of participants, some of which will receive sacituzumab govitecan alone, while others will receive it in combination with other treatments. The study is designed to understand how these treatments work in patients with advanced urothelial cancer. One of the groups (Cohort 5) has been cancelled as of December 2023.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older (19 in South Korea).
  • Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Must have good kidney and liver function.
  • Must have adequate blood cell counts without needing transfusions.
  • Must have a life expectancy of at least 3 months.

Additional Criteria for Specific Groups:

  • Group 1: Cancer has worsened after platinum-based chemotherapy and anti-PD-1/PD-L1 therapy.
  • Group 2: Ineligible for platinum therapy and cancer worsened after anti-PD-1/PD-L1 therapy.
  • Group 3: Cancer worsened after platinum therapy.
  • Group 4: No prior platinum therapy in advanced cancer setting, with specific kidney function requirements.
  • Group 6: No prior therapy for advanced cancer, with specific conditions for checkpoint inhibitor therapy.
  • Group 7: No prior systemic therapy for advanced cancer, with specific conditions for recurrence.

All groups must have measurable disease by CT or MRI and provide a tumor sample.

Exclusion Criteria

  • Women who are pregnant or breastfeeding.
  • Have had a monoclonal antibody treatment within 4 weeks before the study or have not recovered from side effects of previous treatments.
  • Have another active cancer.
  • Have active Hepatitis B or C.
  • Have other serious medical or psychiatric conditions.
  • Have active cancer spread to the brain or spinal cord.

Additional Criteria for Specific Groups:

  • Group 3: Have received anti-PD-1/PD-L1 therapy before.
  • Groups 3 to 6: Have an active autoimmune disease needing treatment in the past 2 years.
  • Groups 3 to 6: Have received a live vaccine within 30 days before the study.
  • Group 4: Cancer returned within 12 months after platinum therapy.
  • Group 7: Have had cancer treatment within 12 months before the study or radiation within 2 weeks before the study.

Other conditions like uncontrolled diabetes, active eye infections, or severe nerve damage may also exclude participation.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.