Study on Adding Tivozanib to Immunotherapy After Surgery for Kidney Cancer
Sponsor: Alliance for Clinical Trials in Oncology
ClinicalTrials ID:NCT06661720
This clinical trial is testing whether adding the drug tivozanib to the standard immunotherapy treatment pembrolizumab can improve outcomes for patients with high-risk kidney cancer after surgery.
Patient Parameters
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Program Overview
The purpose of this study is to see if combining the drug tivozanib with the immunotherapy drug pembrolizumab is more effective than using pembrolizumab alone in treating patients with high-risk kidney cancer. Pembrolizumab helps the immune system attack cancer cells, while tivozanib blocks signals that help cancer cells grow. The study aims to find out if this combination can better prevent the cancer from returning after surgery.
Description
The main goal of this study is to compare how long patients remain free of cancer when treated with pembrolizumab and tivozanib versus pembrolizumab alone. Researchers will also look at overall survival rates and any side effects experienced by participants. Additionally, the study will collect samples for future research and assess the quality of life and fatigue levels reported by patients.
Participants will be randomly assigned to one of two groups:
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Group 1: Receive pembrolizumab through an IV on specific days of each 12-week cycle, for up to 4 cycles, unless the cancer progresses or side effects become too severe. Participants will also have blood tests, scans, and possibly tissue biopsies during the study.
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Group 2: Receive pembrolizumab through an IV and take tivozanib pills on specific days of each 12-week cycle, for up to 4 cycles, unless the cancer progresses or side effects become too severe. Participants will also have blood tests, scans, and possibly tissue biopsies during the study.
After completing the treatment, participants will have follow-up visits every 4 months for 2 years, then every 6 months for 3 years, and annually for 5 more years.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with kidney cancer with specific features and have had surgery to remove the tumor.
- Cancer must be at a high risk of returning, based on certain medical criteria.
- No evidence of cancer at the time of joining the study, confirmed by scans.
- No previous treatment for kidney cancer.
- Aged 18 years or older.
- In good general health, with specific blood counts and organ function within normal limits.
- Not pregnant or breastfeeding, and willing to use effective birth control if of childbearing potential.
- HIV-positive patients can participate if their viral load is undetectable.
- Patients with hepatitis B or C can participate if the infection is under control.
- No history of serious heart, lung, or liver conditions that could interfere with the study.
- No history of organ transplantation or severe allergies to study drugs.
- No use of certain medications that could interfere with the study treatment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Beebe South Coastal Health Campus | 19967 | Millville | Delaware |
| Helen F Graham Cancer Center | 19713 | Newark | Delaware |
| Medical Oncology Hematology Consultants PA | 19713 | Newark | Delaware |
| Beebe Health Campus | 19971 | Rehoboth Beach | Delaware |
| Kootenai Health - Coeur d'Alene | 83814 | Coeur d'Alene | Idaho |
| Kootenai Clinic Cancer Services - Post Falls | 83854 | Post Falls | Idaho |
| Kootenai Clinic Cancer Services - Sandpoint | 83864 | Sandpoint | Idaho |
| Illinois CancerCare-Bloomington | 61704 | Bloomington | Illinois |
| Illinois CancerCare-Canton | 61520 | Canton | Illinois |
| Illinois CancerCare-Carthage | 62321 | Carthage | Illinois |
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