Study Comparing Pembrolizumab and Sacituzumab Govitecan with Standard Treatment for Advanced Urothelial Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT06524544
This clinical trial is testing whether a combination of the drugs pembrolizumab and sacituzumab govitecan is more effective than the usual chemotherapy treatments for patients with advanced urothelial cancer that has spread to nearby tissues or other parts of the body.
Patient Parameters
| Parameter | Options |
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Program Overview
The study aims to find out if using pembrolizumab, an immunotherapy drug, together with sacituzumab govitecan, a targeted chemotherapy, can better control advanced urothelial cancer compared to standard chemotherapy treatments. Pembrolizumab helps the immune system attack cancer cells, while sacituzumab govitecan targets and delivers chemotherapy directly to cancer cells. The usual treatments include chemotherapy drugs like cisplatin, carboplatin, gemcitabine, docetaxel, or paclitaxel. This study will compare the new combination treatment to these standard options to see which is more effective.
Description
The main goal of this study is to compare the overall survival of patients receiving the new combination of sacituzumab govitecan and pembrolizumab with those receiving the standard treatment chosen by their doctor. Secondary goals include comparing how long patients live without the cancer getting worse, the response rate to the treatments, and the duration of response. The study will also look at the side effects of the new treatment and how it affects patients' quality of life.
Participants will be randomly assigned to one of two groups:
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Group A (Standard Treatment): Patients will receive standard chemotherapy, which may include drugs like carboplatin or cisplatin with gemcitabine, or docetaxel or paclitaxel. These treatments are given in cycles every 21 days, up to 6 cycles, unless the cancer progresses or side effects become too severe. Patients will also have regular blood tests and scans.
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Group B (New Treatment): Patients will receive sacituzumab govitecan and pembrolizumab. Sacituzumab govitecan is given on days 1 and 8, and pembrolizumab is given on day 1 of each 21-day cycle. This treatment can continue for up to 35 cycles or 2 years, unless the cancer progresses or side effects become too severe. Patients will also have regular blood tests and scans.
After completing the study treatment, patients will have follow-up visits 30 days later and then once a year for 5 years.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Must have a performance status score of 0-2, indicating good overall health.
- Must have advanced or metastatic urothelial cancer that cannot be removed by surgery.
- Must have cancer that includes at least 1% urothelial cells.
- Must have measurable cancer based on specific criteria.
- Must have had previous treatment for advanced cancer and shown progression.
- Must have received at least one dose of anti-PD(L)1 therapy.
- Must not have progressed within 12 weeks of anti-PD(L)1 therapy.
- Must have had at least one line of systemic therapy for advanced cancer.
- Must not have received sacituzumab govitecan or similar therapies before.
- Must have a Bellmunt score of 0-2, indicating risk level.
- Must not have severe immune-related side effects from previous treatments.
- Must have recovered from previous treatment side effects.
- Must not be pregnant or breastfeeding and must agree to use contraception.
- Must be able to understand and sign a consent form.
- Must have adequate blood counts and organ function based on tests.
- Must not have a known genetic condition affecting drug metabolism.
- HIV-positive patients must have an undetectable viral load.
- Hepatitis B and C patients must have controlled or cured infections.
- Patients with treated brain metastases must show no progression.
- Must not be on high-dose steroids or immunosuppressive medications.
- Must speak English or Spanish for quality of life assessments.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Cancer Care Specialists of Illinois - Decatur | 62526 | Decatur | Illinois |
| Decatur Memorial Hospital | 62526 | Decatur | Illinois |
| Crossroads Cancer Center | 62401 | Effingham | Illinois |
| Southern Illinois University School of Medicine | 62702 | Springfield | Illinois |
| Parkland Health Center - Farmington | 63640 | Farmington | Missouri |
| Sainte Genevieve County Memorial Hospital | 63670 | Sainte Genevieve | Missouri |
| Missouri Baptist Medical Center | 63131 | St Louis | Missouri |
| Missouri Baptist Sullivan Hospital | 63080 | Sullivan | Missouri |
| BJC Outpatient Center at Sunset Hills | 63127 | Sunset Hills | Missouri |
| West Virginia University Charleston Division | 25304 | Charleston | West Virginia |
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