NCT06601296RecruitingPhase 2
Radiotherapy in Combination With Checkpoint Inhibition for Patients With Metastatic Kidney Cancer
STING Agonist and Personalized Ultra-fractionated Stereotactic Adaptive Radiotherapy in Combination With Checkpoint Inhibition for Patients With Metastatic Kidney Cancer.
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
To evaluate the impact of combining innate immune system activation (with IMSA101) with antigen release (through SAbR/PULSAR) on limited progressing lesions during ongoing adaptive immune system activation (with maintenance Nivo).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 11 Sept 2024
- Start date
- 1 Apr 2025
- Primary completion date
- Oct 2027
- Lead sponsor
- University of Texas Southwestern Medical Center
- Diseases
- Kidney cancer
- NCT number
- NCT06601296
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 15
- From 1 Apr 2025 to the primary completion date, Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior high-grade toxicity from check-point inhibitors deemed to place he patient at high risk for toxicity recurrence with re-challenge with check-point inhibitors.
- Prior STING agonist use.
- Any condition requiring systemic treatment with corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to first dose of study drug. Inhaled steroids and adrenal replacement steroid doses up to 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
Other illness
- Uncontrolled adrenal insufficiency.
Who the study is looking for
- Patients must have metastatic ccRCC.
- Patients must have oligoprogressive disease (up to 5 progressing lesions) on any ongoing or prior check-point inhibitor regimen that are all amenable to radiation including one lesion suitable for IMSA101 injection.
- Karnofsky Performance Status (KPS) of at least 50%.
- Life expectancy of at least 6 months.
- Age ≥ 18 years.
- Patients must have adequate organ and marrow function within 14 days prior to study entry.
- All IMDC risk categories are allowed.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Texas Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.