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

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT06601296
Phase
PHASE2
Status
Recruiting
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Conditions

  • Metastatic Renal Cell Carcinoma ( mRCC)
  • OligoProgressive Metastatic Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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)

Study Details

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).

Key Dates

Start date
Apr 1, 2025
Status verified
Nov 2025
Primary completion
Oct 31, 2027
Completion
Oct 31, 2028

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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)

Primary Outcome Measure

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 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 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Southwestern Medical CenterDallasTexas75390
BUSAYO ADEFALUJO, CLINICAL RESEARCH COORDINATOR
[email protected]
214 648 1873
SARAH NEUFELD SUPERVISOR OF CLINICAL RESEARCH, MS, MBA
[email protected]
214 648 1836
RAQUIBUL HANNAN, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Texas Southwestern Medical Center· Dallas, TX

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