Status:
RECRUITING
Radiotherapy in Combination With Checkpoint Inhibition for Patients With Metastatic Kidney Cancer
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Metastatic Renal Cell Carcinoma ( mRCC)
OligoProgressive Metastatic Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To evaluate the impact of combining innate immune system activation (with IMSA101) with antigen release (through SAbR/PULSAR) on limited progressing lesions during ongoing adaptive immune system activ...
Detailed Description
The study expects to accrue the 15 patients over a 3-4 year period. Patients with oligoprogressive disease (≤5 lesions) after treatment with Anti-PD1 / Anti-CTLA-4 will continue Anti-PD1 (nivolumab)....
Eligibility Criteria
Inclusion
- 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
- Patients with progressive ultracentral/central chest lesions will be excluded
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06601296
Start Date
April 1 2025
End Date
October 1 2028
Last Update
November 12 2025
Active Locations (1)
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1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390