Treatment Study Combining Immune Activation and Targeted Radiotherapy for Metastatic Kidney Cancer with Limited Progressing Lesions

What this Trial Is About

Researchers are evaluating the combination of innate immune system activation using IMSA101 with antigen release through personalized stereotactic adaptive radiotherapy PULSAR during ongoing adaptive immune system activation with maintenance nivolumab in patients with metastatic kidney cancer. This phase 2 study focuses on patients with limited progressing lesions oligoprogression after prior treatment with immune checkpoint inhibitors. The goal is to understand the effect of this combined approach on disease progression. All participants will receive standard nivolumab treatment at 480 mg monthly. The PULSAR regimen involves delivering 36 Gy of radiation in 3 fractions spaced four weeks apart to all progressing lesions. One lesion will receive three intratumoral injections of IMSA101 at a dose of 1200 mcg on specific days during the first three cycles, either on the same day as radiation or within 72 hours. Imaging and biopsies are conducted before and during treatment to monitor responses. Participants will undergo mandatory PD-L1 PET scans before treatment and at week 12, along with baseline biopsies of the lesion to be injected with IMSA101. Follow-up visits occur every 12 weeks to assess disease progression using RECIST 1.1 criteria, with survival data collected for up to five years. If disease progresses, additional imaging and tissue or blood samples may be collected. Total participation spans the treatment and follow-up periods as outlined.

Radiotherapy in Combination With Checkpoint Inhibition for Patients With Metastatic Kidney Cancer