Radiotherapy in Combination With Checkpoint Inhibition for Patients With Metastatic Kidney Cancer
STING Agonist and Personalized Ultra-fractionated Stereotactic Adaptive Radiotherapy in Combination With Checkpoint Inhibition for Patients With Metastatic Kidney Cancer.
University of Texas Southwestern Medical Center
15 participants
Apr 1, 2025
INTERVENTIONAL
Conditions
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 activation (with maintenance Nivo).
Eligibility
Inclusion Criteria8
- 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 Criteria1
- Patients with progressive ultracentral/central chest lesions will be excluded
Interventions
All enrolled patients to undergo the following treatment: SOC treatment: Nivolumab 480mg monthly PULSAR: 36 Gy in 3 fractions, Q4weeks IMSA101: three intra-tumoral injections of one of the progressive lesions at 1200 mcg (C1D1, C2D1, C3D1)
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06601296