Study on Pembrolizumab and Enfortumab Vedotin Before and After Surgery for High-Risk Upper Tract Urothelial Cancer
Sponsor: Jonsson Comprehensive Cancer Center
ClinicalTrials ID:NCT05775471
This clinical trial is exploring the effectiveness of combining pembrolizumab and enfortumab vedotin before and after surgery to treat patients with high-risk upper tract urothelial cancer. The study aims to see if this combination can shrink tumors before surgery and eliminate remaining cancer cells afterward.
Patient Parameters
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Program Overview
This phase II study is testing how well the combination of pembrolizumab and enfortumab vedotin works when given before and after surgery in patients with high-risk upper tract urothelial cancer. Pembrolizumab is an immunotherapy drug that helps the immune system attack cancer cells, while enfortumab vedotin is a targeted therapy that delivers a cancer-killing drug directly to the tumor. The surgery, called radical nephroureterectomy, involves removing a kidney and its ureter. The goal is to see if this treatment can shrink the tumor before surgery and kill any remaining cancer cells afterward.
Description
The main goals of this study are to see how well the treatment works in shrinking the tumor before surgery and to check if it helps patients live longer without the cancer coming back after surgery. Researchers will also look at the side effects and any surgical complications from the treatment.
Participants will receive pembrolizumab and enfortumab vedotin through an IV. They will then undergo surgery to remove the affected kidney and ureter. After surgery, they will continue to receive pembrolizumab. Throughout the study, participants will have imaging tests and provide blood, urine, and tissue samples to help researchers understand how the treatment is working.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older with a confirmed diagnosis of high-risk upper tract urothelial cancer.
- Men must agree to use contraception during treatment and for 6 months after the last dose.
- Women must not be pregnant or breastfeeding and must agree to use contraception during treatment and for 6 months after the last dose.
- Must provide a tumor tissue sample for analysis.
- Must have a good performance status, meaning they are fully active or have some restrictions but can still do light work.
- Must have adequate blood cell counts and organ function as determined by specific tests.
Exclusion Criteria
- Women who are pregnant or breastfeeding.
- Have received certain cancer treatments or investigational drugs recently.
- Have active infections or other serious medical conditions.
- Have a history of severe allergic reactions to pembrolizumab or enfortumab vedotin.
- Have active autoimmune diseases requiring treatment in the past 2 years.
- Have known active brain metastases or certain viral infections like HIV or Hepatitis B or C.
- Have had an organ transplant or have a life expectancy of less than 12 weeks.
- Have psychiatric or substance abuse disorders that would interfere with the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UCLA / Jonsson Comprehensive Cancer Center | 90095 | Los Angeles | California |
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