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Radiotherapy and IMSA101 for Metastatic Kidney Cancer

This study is looking at a new way to treat metastatic kidney cancer (renal cell carcinoma) that has spread to other parts of the body and is progressing in a limited number of spots (oligoprogressive disease). It combines your current treatment, nivolumab, with radiation therapy (PULSAR) and a drug called IMSA101. Researchers want to see if this combination can stop the cancer from growing for longer. To join, you must have metastatic kidney cancer with progression in 5 or fewer lesions, and these lesions must be suitable for radiation and injection. The study will measure how long patients live without their disease getting worse. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 15 participants. All participants will receive the study treatments.
What's involved
You will receive nivolumab monthly, radiation therapy (PULSAR) every 4 weeks to progressing lesions, and three injections of IMSA101 into one lesion. You will have follow-up visits every 12 weeks until your disease progresses, and then every 6 months for survival data for up to 5 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for survival data every 6 months for up to 5 years after their disease progresses.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06601296

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Texas Southwestern Medical Center
~15 participants
Updated 2025-11-12 on ClinicalTrials.gov
What's tested:IMSA101

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
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.
Measured over 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

Conditions

Metastatic Renal Cell Carcinoma ( mRCC)
OligoProgressive Metastatic Disease

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Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Texas Southwestern Medical Center

    Dallas, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • RAQUIBUL HANNAN, MD · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center

Who to contact

SARAH NEUFELD, MANAGER OF CLINICAL RESEARCH, MS, MBA
[email protected]
214 648 1836
Email the study team

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Eligibility criteria

Inclusion

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

Patients with progressive ultracentral/central chest lesions will be excluded

What this trial measures

  • 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

    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%.