Radiotherapy in Combination With Checkpoint Inhibition for Patients With Metastatic Kidney Cancer
NCT ID: NCT06601296
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
15 participants
INTERVENTIONAL
2025-04-01
2028-10-31
Brief Summary
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Detailed Description
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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) immediately after radiation either on the same day or within 72 hours after the PULSE.
Selected Phase 2 dosing of IMSA101 (1200mcg) will be utilized.
At disease progression, patients have the option to undergo additional imaging and tissue/blood collections.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SAbR with Intratumoral STING agonist IMSA101 and IO with Anti-PD1
Only one arm will be maintained in this phase II study with all patients undergoing the following treatment:
SOC treatment: Nivolumab 480 mg 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)
IMSA101
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)
Interventions
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IMSA101
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)
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University of Texas Southwestern Medical Center
OTHER
Responsible Party
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Raquibul Hannan
MD
Principal Investigators
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RAQUIBUL HANNAN, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas Southwestern Medical Center
Locations
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University of Texas Southwestern Medical Center
Dallas, Texas, United States
Countries
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Central Contacts
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SARAH NEUFELD, MANAGER OF CLINICAL RESEARCH, MS, MBA
Role: CONTACT
Phone: 214 648 1836
Email: [email protected]
Facility Contacts
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BUSAYO ADEFALUJO, CLINICAL RESEARCH COORDINATOR
Role: primary
SARAH NEUFELD SUPERVISOR OF CLINICAL RESEARCH, MS, MBA
Role: backup
Other Identifiers
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2024-0919
Identifier Type: -
Identifier Source: org_study_id