Actively Recruiting
STM-06: POLARIS-POlymetastic Lesion Ablative Radiotherapy With Immunotherapy Study
Led by University of Illinois at Chicago · Updated on 2026-03-02
28
Participants Needed
1
Research Sites
151 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a non-randomized two-arm trial, specifically a pilot study in which patients with advanced solid tumor cancer with 3-10 metastatic lesions who are on immunotherapy will receive ablative RT to up to 10 lesions. After study intervention, participants will undergo ctDNA collection at 8 weeks after completion of ablative RT Post-treatment disease assessments, including imaging and serial ctDNA monitoring, as well as any additional treatments, will be at the discretion of the treating oncologist. Approximately 28 subjects (14 per cohort) will be enrolled. For subjects who do not complete the full planned course of RT for any reason, a final study visit should be performed approximately 30 days after the last fraction of radiation. If a subject is discontinued from the study with an ongoing adverse event or an unresolved clinically significant laboratory result, the clinical investigative team will attempt to provide follow-up until a satisfactory clinical resolution of the laboratory result or adverse event is achieved.
CONDITIONS
Official Title
STM-06: POLARIS-POlymetastic Lesion Ablative Radiotherapy With Immunotherapy Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of consent
- ECOG performance status 0, 1, or 2 within 30 days before registration
- Advanced solid tumors with 3 to 10 metastatic sites, excluding the primary tumor
- Metastatic sites must be outside the gastrointestinal tract, brainstem, and skin
- Adequate organ function based on screening labs obtained within 30 days prior to registration
- Able to provide written informed consent or have a legally authorized representative consent
- Women of childbearing potential must have a negative pregnancy test and not be pregnant or breastfeeding
- Ability to understand and comply with study procedures for the entire study duration
- Life expectancy of at least 3 months
- Receiving FDA-approved immunotherapy (PD-1, PD-L1, CTLA-4, or LAG-3 inhibitors) for more than 3 months as monotherapy or combination
- Cohort A: stable disease or partial response after more than 3 months of immunotherapy
- Cohort B: oligo-progression with 3 or more sites of disease and 1 to 5 sites progressing within 3 months, with prior best response being stable disease, partial, or complete response, and on immunotherapy for at least 3 months
You will not qualify if you...
- Inability to treat all sites of disease
- More than 10 metastatic lesions at any time during disease course
- History of interstitial lung disease or Grade 3 or worse pneumonitis
- Malignant pleural effusion
- Active infection requiring intravenous antibiotics
- Active autoimmune disease needing immunosuppression within the last 2 years
- Significant medical conditions preventing radiotherapy as judged by treating physician
- Use of systemic corticosteroids equivalent to prednisone 10 mg daily or higher within 14 days prior to registration, or requirement of such steroids for disease control
- Significant overlap with previously treated radiation area
- Moderate or severe liver dysfunction (Child-Pugh B or C) in patients with liver metastases
- Symptomatic brain metastases, any single brain metastasis larger than 5 cm, or total brain metastases volume over 30 cc
- Clinical or radiologic signs of spinal cord compression
- Metastatic disease involving gastrointestinal tract, brainstem, or skin
- Pregnant or nursing women
- Any prior or concurrent cancer that could interfere with safety or efficacy assessment
- Other major comorbidities as determined by the study principal investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Actively Recruiting
Research Team
R
Ryan Nguyen, DO
CONTACT
O
Omer Qazi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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