Radiotherapy in Combination With Checkpoint Inhibition for Patients With Metastatic Kidney Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Texas Southwestern Medical Center
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients with progressive ultracentral/central chest lesions will be excluded
Trial design
Design model
Single group
Treatments tested in this trial
IMSA101
DrugAll 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)
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: SAbR with Intratumoral STING agonist IMSA101 and IO with Anti-PD1Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To evaluate the PFS rate associated with the therapeutic intervention. PFS is defined as the duration of time from initiation of PULSAR/IMSA101 to disease progression as defined by RECIST1.1 or death.
Exact binomial test will be used to test if the lower limit of the 95% confidence interval of the probability of postponing systemic therapy \>9 months will be greater than 30%.
Time frame
Time from initiation of PULSAR/IMSA101 until death from any cause. Follow-up visits to be done every 12 weeks (+/- 1 week) for study duration until patient has progressed. Afterward, subjects to be contacted every 6 months for survival data up to 5 yearsSponsors and contacts
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Source ClinicalTrials.gov