Study on Combining Radiotherapy with Checkpoint Inhibition for Patients with Metastatic Kidney Cancer
Sponsor: University of Texas Southwestern Medical Center
ClinicalTrials ID:NCT06601296
This clinical trial is testing a new treatment approach that combines radiotherapy with an injectable drug, IMSA101, to see if it can help control the progression of metastatic kidney cancer.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The purpose of this study is to evaluate how well a new treatment combination works for patients with metastatic kidney cancer. The treatment involves using a special type of radiotherapy called PULSAR, along with an injectable drug called IMSA101. The study will monitor the progression of the cancer from the start of this treatment onward.
Description
This study plans to enroll 20 patients over a period of 3 to 4 years. It focuses on patients whose kidney cancer has spread to a few areas (1-3 lesions) and has shown some progression after previous treatments. These patients will continue receiving a medication called nivolumab, which is an Anti-PD1 therapy.
All participants will undergo a special PET scan before starting the treatment and again at 12 weeks. They will also have a biopsy taken from the tumor before receiving the IMSA101 injection. The radiotherapy, known as SAbR, will be given in three doses every four weeks to all progressing cancer areas. One of these areas will also receive five injections of IMSA101 directly into the tumor, either on the same day as the radiotherapy or within three days after.
The study uses a specific dose of IMSA101 (1200mcg) for this phase. If the cancer progresses, patients may have additional imaging and tissue or blood samples collected to help researchers understand the treatment's effects.
Eligibility Criteria
Inclusion Criteria
- Have metastatic clear cell renal cell carcinoma (ccRCC).
- Have cancer that is progressing in 3 or fewer areas.
- All progressing areas must be suitable for radiation treatment.
- Have at least one tumor that can be safely injected with IMSA101 (lung tumors are not eligible).
- Be in relatively good health with an ECOG performance status of 0 to 2.
- Be 18 years or older.
- Have adequate organ and bone marrow function as confirmed by tests within 14 days before joining the study.
- All risk categories are allowed.
Exclusion Criteria
- Patients with progressing tumors in the central chest area will not be eligible.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Texas Southwestern Medical Center | 75390 | Dallas | Texas |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.