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

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexAll
• Healthy volunteersNo

You may be able to join if

• Patients must have metastatic ccRCC.
• Patients must have oligoprogressive disease (up to 5 progressing lesions) on any ongoing or prior check-point inhibitor regimen that are all amenable to radiation including one lesion suitable for IMSA101 injection.
• Karnofsky Performance Status (KPS) of at least 50%.
• Life expectancy of at least 6 months.
• Age ≥ 18 years.
• Patients must have adequate organ and marrow function within 14 days prior to study entry.
• All IMDC risk categories are allowed.

You cannot join if

• Prior high-grade toxicity from check-point inhibitors deemed to place he patient at high risk for toxicity recurrence with re-challenge with check-point inhibitors.
• Prior STING agonist use.
• Any condition requiring systemic treatment with corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to first dose of study drug. Inhaled steroids and adrenal replacement steroid doses up to 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
• Uncontrolled adrenal insufficiency.

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

STING agonist IMSA101. A small molecule analogue of cyclic GMP-AMP (cGAMP) that acts as an agonist of the stimulator of interferon genes protein (STING; transmembrane protein 173; TMEM173) with potential immunoactivating and antineoplastic activities. Upon intratumoral administration, STING agonist IMSA101 binds to STING and activates STING-mediated pathways. This activates the immune response through the activation of certain immune cells which induces the expression of pro-inflammatory cytokines and chemokines, promotes tumor-associated antigen (TAA) processing and presentation by dendritic cells (DCs) and leads to an antigen-specific T-cell mediated immune response against cancer cells. STING, a transmembrane protein that activates immune cells in the tumor microenvironment, plays a key role in the activation of the innate immune system. NCI Drug Dictionary

nivolumab. A fully human immunoglobulin (Ig) G4 monoclonal antibody directed against the negative immunoregulatory human cell surface receptor programmed death-1 (PD-1, PCD-1) with immune checkpoint inhibitory and antineoplastic activities. Upon administration, nivolumab binds to and blocks the activation of PD-1, an immunoglobulin superfamily (IgSF) transmembrane protein, by its ligands programmed cell death ligand 1 (PD-L1), which is overexpressed on certain cancer cells, and programmed cell death ligand 2 (PD-L2), which is primarily expressed on antigen-presenting cells (APCs). This results in the activation of T cells and cell-mediated immune responses against tumor cells. Activated PD-1 negatively regulates T-cell activation and plays a key role in tumor evasion from host immunity. NCI Drug Dictionary

Treatments listed in the registry

• IMSA101 (Drug): 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)

Na · Single Group · masking: None

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

• biopsy: Part of the study plan
• blood samples: Part of the study plan

Main goals

• 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. (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)

Planned enrollment: 15 (estimated).

• University of Texas Southwestern Medical Center, Dallas, Texas

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT06601296
• NCI Drug Dictionary: C165655
• NCI Drug Dictionary: C68814

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Oct 28, 2026. Public record; not medical advice.