Radiotherapy in Combination With Checkpoint Inhibition for Patients With Metastatic Kidney Cancer
Sponsor: University of Texas Southwestern Medical Center
ClinicalTrials ID:NCT06601296
This trial evaluates metastatic renal cell carcinoma progression using PULSAR radiotherapy and IMSA101. It involves 20 patients over 3-4 years, requiring oligoprogression (≤3 lesions) and suitable radiation sites. Patients continue nivolumab and receive IMSA101 injections. Eligibility includes age ≥18, ECOG 0-2, and adequate organ function. Excludes lung metastases.
Patient Parameters
| Parameter | Options |
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Program Overview
To evaluate progression of metastatic renal cell carcinoma from the initiation of PULSAR radiotherapy in combination with IMSA101 injectable onward.
Description
The study expects to accrue the 20 patients over a 3-4 year period.
Patients with oligoprogressive disease (1-3 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 5 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.
Eligibility Criteria
Inclusion Criteria
- Patients must have metastatic ccRCC.
- Patients must have oligoprogression defined as progression in ≤3 lesions.
- All oligoprogression lesions must be suitable for radiation.
- Patients must have at least one site of disease that can be safely injected with IMSA101. Lung metastases are excluded.
- ECOG performance status 0-2.
- Age ≥ 18 years.
- Patients must have adequate organ and marrow function within 14 days prior to study entry.
- All IMDC risk categories are allowed.
Exclusion Criteria
- Patients with progressive ultracentral/central chest lesions will be excluded
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Texas Southwestern Medical Center | 75390 | Dallas | Texas |
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