Focal Ablation Plus Immunotherapy for Oligometastatic Disease
Focal ablation plus immunotherapy trial for oligometastatic cancer. Phase I study combining targeted radiation with pembrolizumab.
Phase I Study of Focal Ablation Combined with Immunotherapy for Oligometastatic Disease
Full Title
A phase I, open-label study of stereotactic ablative radiotherapy or radiofrequency ablation combined with pembrolizumab in patients with oligometastatic solid tumors (1-5 metastatic sites)
Purpose
When cancer spreads to only a few spots (1-5 areas), destroying those spots with radiation or heat while giving immunotherapy may help your immune system recognize and attack cancer throughout your body. This combination approach may control cancer better than either treatment alone.
Primary Objectives
- Evaluate safety and tolerability of combining focal ablation with pembrolizumab
- Determine optimal timing and sequencing of ablation and immunotherapy
- Assess systemic immune activation following focal ablation plus immunotherapy
Diseases
Who Can Join this Trial
To participate in this study, you must meet ALL of the following criteria
- Have histologically confirmed solid tumor malignancy with oligometastatic disease (1-5 metastatic lesions)
- All metastatic sites must be amenable to focal ablation
- Primary tumor must be controlled or controllable with local therapy
- Each metastatic lesion must be ≤5 cm in maximum diameter
- ECOG performance status 0-2
- Age 18 years or older
- Life expectancy ≥6 months
- Adequate organ function including blood counts, liver, and kidney function
- No prior immunotherapy with anti-PD-1/PD-L1 agents within 6 months
- No contraindications to focal ablation
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