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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Illinois at Chicago
Study ID
NCT07269080
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumor
  • Metastatic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ablative radiation treatment — RADIATION
    Ablative radiation for all metastases should be completed within 3 weeks of the first dose of radiation. Metastases may be treated on an everyday or every other day schedule.

Study Details

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.

Key Dates

Start date
Dec 8, 2025
Status verified
Feb 2026
Primary completion
Jan 31, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
28 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Treatment with Radiotherapy in Participants with Stable Disease or Partial Response
    Participants with investigator-assessed stable disease or partial response after \> 3 months of immunotherapy treatment prior to registration
  • Other: Treatment with Radiotherapy in Patients with Oligo-progression
    Participants 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. Participants 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.

Primary Outcome Measure

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 [ Time Frame: Baseline to 8 weeks following the end of ablative radiation therapy ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Illinois at ChicagoChicagoIllinois60612
Ryan Nguyen, DO

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By research site
University of Illinois at Chicago· Chicago, IL

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