Trials / Recruiting
RecruitingNCT06601296
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.
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- Sponsor
- University of Texas Southwestern Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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).
Detailed description
The study expects to accrue the 15 patients over a 3-4 year period. Patients with oligoprogressive disease (≤5 lesions) after treatment with Anti-PD1 / Anti-CTLA-4 will continue Anti-PD1 (nivolumab). All patients will have a mandatory PD-L1 PET (Pre-treatment and Week 12). All patients will undergo baseline biopsy (just before the administration of IMSA101 of the same lesion to be injected). SAbR will be delivered in 3 fractions at 12 Gy every 4 weeks (PULSAR regimen) to all progressing lesions. One lesion will also receive 3 intratumoral injections of IMSA101 (C1D1, C1D8, C1D15, C2D1, C3D1) immediately after radiation either on the same day or within 72 hours after the PULSE. Selected Phase 2 dosing of IMSA101 (1200mcg) will be utilized. At disease progression, patients have the option to undergo additional imaging and tissue/blood collections.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IMSA101 | All enrolled patients to undergo the following treatment: SOC treatment: Nivolumab 480mg monthly PULSAR: 36 Gy in 3 fractions, Q4weeks IMSA101: three intra-tumoral injections of one of the progressive lesions at 1200 mcg (C1D1, C2D1, C3D1) |
Timeline
- Start date
- 2025-04-01
- Primary completion
- 2027-10-01
- Completion
- 2028-10-01
- First posted
- 2024-09-19
- Last updated
- 2025-11-12
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06601296. Inclusion in this directory is not an endorsement.