POLARIS Study: Radiation and Immunotherapy for Advanced Solid Tumors
This study, called POLARIS, is for people with advanced solid tumors that have spread to 3 to 10 other places in the body (metastatic disease). You can join if you are already receiving immunotherapy. The study will test if ablative radiation treatment (a type of focused radiation) given to these metastatic spots, along with your immunotherapy, can reduce the amount of cancer DNA in your blood. Researchers will measure this reduction at 8 weeks after your radiation treatment ends. This is a pilot study aiming to enroll about 28 participants. The current recruitment status is unclear.
- Study design
- This is a pilot study with two groups, enrolling about 28 participants in total. It is not randomized, meaning participants are not assigned to groups by chance.
- What's involved
- You will receive ablative radiation treatment to up to 10 metastatic lesions within 3 weeks. Blood samples will be collected at 8 weeks after your radiation treatment is complete.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your cancer DNA will be checked at 8 weeks after the radiation treatment ends. If you don't complete the full radiation course, a final visit will be about 30 days after your last radiation treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07269080
STM-06: POLARIS-POlymetastic Lesion Ablative Radiotherapy With Immunotherapy Study
Recruiting
PHASE1Ages 18+InterventionalTreatmentUniversity of Illinois at ChicagoInvestigator-initiated
~28 participants
Updated 2026-03-02 on ClinicalTrials.gov
What's tested:Ablative radiation treatment
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To estimate the proportion of patients with advanced tumors and polymetastatic disease on immunotherapy who achieve a molecular response (>50% ctDNA reduction) at 8 weeks following ablative radiation therapy
Measured over Baseline to 8 weeks following the end of ablative radiation therapy
Conditions
NCT07269080
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
University of Illinois at Chicago
Chicago, Illinoisno site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Ryan Nguyen, DO · PRINCIPAL_INVESTIGATOR · University of Illinois at Chicago
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Eligibility criteria
Inclusion
Age ≥ 18 years of age at the time of consent
ECOG (0, 1, or 2) within 30 days prior to registration.
Subjects with advanced solid tumors with at least 3 but no more than 10 sites of metastatic disease, excluding the primary tumor.
Disease site must be outside of the GI tract (including esophagus, stomach, small or large bowel, and mesenteric lymph nodes), brainstem, and skin.
Demonstrates adequate organ function. All screening labs are to be obtained within 30 days prior to registration.
Able to provide written informed consent and HIPAA authorization for release of personal health information via an approved UIC Institutional Review Board (IRB) informed consent form and HIPAA authorization. If a subject is unable to consent, a Legally Authorized Representative (LAR) may provide consent on their behalf.
Women of childbearing potential must not be pregnant or breastfeeding. A negative serum or urine pregnancy test is required per institutional practice guidelines.
As determined at the discretion of the enrolling physician or protocol designee, the ability of the subject to understand and comply with study procedures for the entire length of the study.
Have a life expectancy of at least 3 months.
Subjects receiving treatment for \>3 months with an FDA-approved immunotherapy agent such as a PD-1 inhibitor, a PD-L1 inhibitor, a CTLA-4 inhibitor, or an LAG-3 inhibitor; either as monotherapy or in combination with another FDA-approved immunotherapy agent. Subjects may have received prior combination cytotoxic chemotherapy and immunotherapy, but must be receiving only immunotherapy for at least 30 days prior to registration.
Cohort A: Subjects with investigator-assessed stable disease or partial response after \> 3 months of immunotherapy treatment prior to registration
Cohort B: Subjects with oligo-progression defined as having at least 3 sites of disease during their disease course, with at least 1 but up to 5 sites of progressive disease within 3 months of registration. Subjects must have investigator-assessed stable disease, partial response, or complete response as prior best response to immunotherapy and have been on immunotherapy for at least 3 months prior to registration.
Exclusion
Inability to treat all sites of disease
\>10 metastatic lesions at any point in the disease course
History of interstitial lung disease or G3 or worse pneumonitis
Malignant pleural effusion
Active infection requiring IV antibiotics
Active autoimmune disease requiring immunosuppression in the last two years from enrollment.
Significant medical comorbidities precluding radiotherapy as determined by the treating physician.
Use of systemic corticosteroids equivalent to prednisone ≥10 mg daily within 14 days prior to registration, or requirement for systemic corticosteroids at screening for disease control, unless used as physiologic replacement (e.g., adrenal insufficiency). Subjects who require systemic steroids ≥10 mg/day for clinical management will be ineligible.
Substantial overlap with a previously treated radiation volume.
For patients with liver metastases, moderate/severe liver dysfunction (Child-Pugh B or C)
Patients with symptomatic brain metastases, a single metastasis greater than 5 cm in size, or any brain metastasis greater than 3 cm in size. Patients with total brain metastases volume exceeding 30 cc.
Clinical or radiologic evidence of spinal cord compression.
Metastatic disease involving the GI tract (esophagus, stomach, small or large bowel, mesenteric lymph nodes), disease in the brainstem, or skin
Pregnant or nursing
Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this investigational regimen, as determined by the treating medical oncologist.
Other major comorbidity, as determined by the study PI
What this trial measures
- To estimate the proportion of patients with advanced tumors and polymetastatic disease on immunotherapy who achieve a molecular response (>50% ctDNA reduction) at 8 weeks following ablative radiation therapyBaseline to 8 weeks following the end of ablative radiation therapy