Combining radiotherapy with checkpoint inhibition for metastatic kidney cancer
STING Agonist and Personalized Ultra-fractionated Stereotactic Adaptive Radiotherapy in Combination With Checkpoint Inhibition for Patients With Metastatic Kidney Cancer.
This study is testing if combining a new type of radiotherapy with an injectable treatment can help patients with advanced kidney cancer whose disease has continued to progress after previous therapies.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Drugs / interventions | radiation, nivolumab |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT06601296 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of PULSAR radiotherapy combined with IMSA101 injectable for patients with metastatic renal cell carcinoma (mRCC) who have oligoprogressive disease. It aims to enroll 20 patients over a 3-4 year period, focusing on those with 1-3 lesions that have progressed after treatment with Anti-PD1/Anti-CTLA-4. Participants will receive a baseline biopsy and undergo a specific radiotherapy regimen followed by intratumoral injections of IMSA101. The study will also monitor disease progression through imaging and tissue/blood collections.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with metastatic clear cell renal cell carcinoma and oligoprogression defined as progression in 1-3 lesions.
Not a fit: Patients with progressive ultracentral/central chest lesions or those with lung metastases will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with oligoprogressive metastatic kidney cancer.
How similar studies have performed: Other studies have shown promise in combining radiotherapy with immunotherapy, suggesting potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients must have metastatic ccRCC. * Patients must have oligoprogression defined as progression in ≤5 lesions. * All oligoprogression lesions must be suitable for radiation. * Patients must have at least one site of disease that can be safely injected with IMSA101. * Karnofsky Performance Status (KPS) of at least 50%. * Age ≥ 18 years. * Patients must have adequate organ and marrow function within 14 days prior to study entry. * All IMDC risk categories are allowed. Exclusion Criteria: * Patients with progressive ultracentral/central chest lesions will be excluded
Where this trial is running
Dallas, Texas
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Raquibul Hannan, Md — University of Texas Southwestern Medical Center
- Study coordinator: Sarah Neufeld, Manager of Clinical Research, Ms, Mba
- Email: Sarah.Hardee@UTSouthwestern.edu
- Phone: 214 648 1836
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.