University of Texas Southwestern Medical Center
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).
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)…
Inclusion Criteria: * Patients must have metastatic ccRCC. * Patients must have oligoprogression defined as progression in ≤5 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. * Karnofsky Performance Status (KPS) of at least 50%. * 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
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)
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