What is this study trying to find out about advanced solid tumors?

This study is evaluating ablative radiation therapy combined with immunotherapy in patients with advanced solid tumors and multiple metastatic lesions. Researchers want to understand how this treatment affects tumor DNA levels and patient outcomes. The University of Illinois at Chicago is leading this research to explore new ways to manage advanced cancer.

Who may be eligible for this advanced solid tumor clinical trial?

Adults aged 18 years or older with advanced solid tumors having 3 to 10 metastatic lesions outside certain areas may be eligible. Participants must have been on immunotherapy for at least 3 months and have adequate organ function. Both men and women can join. Please review eligibility criteria for more details.

Is there any cost to participate in this advanced solid tumor clinical trial?

Study-related care, including the radiation treatment and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for transportation and lodging costs.

Actively Recruiting

Phase 1

Age: 18Years +

All Genders

ID07269080

STM-06 POLARIS-POlymetastic Lesion Ablative Radiotherapy With Immunotherapy Study

Led by University of Illinois at Chicago · Updated on 2026-03-02

Participants Needed

Research Sites

43 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating a pilot study involving patients with advanced solid tumors who have 3 to 10 metastatic lesions and are currently receiving immunotherapy. This non-randomized trial aims to study the effects of ablative radiation therapy on up to 10 metastases in these patients. The study focuses on patients who have stable disease, partial response, or oligo-progression after at least 3 months of immunotherapy treatment, assessing molecular responses and survival outcomes. Participants will receive ablative radiation treatment targeting all metastatic lesions within three weeks, delivered either daily or every other day. The study includes two groups one with stable disease or partial response after immunotherapy, and another with oligo-progression featuring limited sites of progressive disease. After radiation therapy, blood samples for circulating tumor DNA ctDNA will be collected at 8 weeks to evaluate molecular response. During the study, patients will undergo disease assessments including imaging and serial ctDNA monitoring, with further treatments decided by their oncologist. A final study visit occurs about 30 days after the last radiation dose if treatment is not completed. Safety follow-up is provided for ongoing adverse events. The primary outcome is the proportion of patients achieving a significant ctDNA reduction, with secondary outcomes including overall survival, progression-free survival, response rate, and treatment-related side effects over about 12 months.

CONDITIONS

Brief Title

STM-06: POLARIS-POlymetastic Lesion Ablative Radiotherapy With Immunotherapy Study

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Age 18 years or older at the time of consent
ECOG performance status of 0, 1, or 2 within 30 days prior to registration
Advanced solid tumors with 3 to 10 metastatic sites excluding the primary tumor
Metastatic disease outside the gastrointestinal tract (esophagus, stomach, small or large bowel, mesenteric lymph nodes), brainstem, and skin
Adequate organ function confirmed by screening labs within 30 days prior to registration
Ability to provide written informed consent or have a legally authorized representative do so
Women of childbearing potential must have a negative pregnancy test and not be 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 for more than 3 months, either alone or combined with another agent
Cohort A: Stable disease or partial response after more than 3 months of immunotherapy
Cohort B: Oligo-progression with at least 3 disease sites and 1 to 5 progressive sites within 3 months prior to registration, with prior best response stable disease, partial, or complete response to immunotherapy

You will not qualify if you...

Inability to treat all disease sites
More than 10 metastatic lesions at any time
History of interstitial lung disease or grade 3 or worse pneumonitis
Malignant pleural effusion
Active infection requiring intravenous antibiotics
Active autoimmune disease requiring immunosuppression within the past 2 years
Significant medical conditions preventing radiotherapy
Use of systemic corticosteroids equivalent to prednisone 10 mg daily or higher within 14 days prior to registration, except physiologic replacement
Significant overlap with previously treated radiation areas
Moderate or severe liver dysfunction for patients with liver metastases
Symptomatic brain metastases, single metastasis larger than 5 cm, any brain metastasis larger than 3 cm, or total brain metastases volume over 30 cc
Evidence of spinal cord compression
Metastatic disease involving the gastrointestinal tract, brainstem, or skin
Pregnant or nursing women
Prior or concurrent cancers that may interfere with safety or study assessments
Other major comorbidities as determined by the study investigator

Research Team

Ryan Nguyen, DO

Omer Qazi

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