RecruitingPhase 2

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

United States15 participantsStarted 2025-04-01

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

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.

Timeframe: 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 years

Trial details

NCT IDNCT06601296

SponsorUniversity of Texas Southwestern Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-10

Contact for this trial

SARAH NEUFELD, MANAGER OF CLINICAL RESEARCH, MS, MBA

214 648 1836 Sarah.Hardee@UTSouthwestern.edu