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New treatment option for Advanced Solid Tumor
Official title STM-06: POLARIS-POlymetastic Lesion Ablative Radiotherapy With Immunotherapy Study
ClinicalTrials.gov ID: NCT07269080
What this study is testing
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years of age at the time of consent
- ECOG (0, 1, or 2) within 30 days prior to registration.
- people 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.
You likely can't join if
- 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.
See the full eligibility criteria
Who can join
- Age ≥ 18 years of age at the time of consent
- ECOG (0, 1, or 2) within 30 days prior to registration.
- people 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...
- 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.
- people 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...
- Cohort A: people with investigator-assessed stable disease or partial response after \> 3 months of immunotherapy treatment prior to registration
- Cohort B: people 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. people must...
What rules you out
- 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...
- 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 how well it works assessment of this investigational regimen, as determined by the treating medical...
- Other major comorbidity, as determined by the study PI
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.