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Trial Title:
Radiotherapy in Combination With Checkpoint Inhibition for Patients With Metastatic Kidney Cancer
NCT ID:
NCT06601296
Condition:
Metastatic Renal Cell Carcinoma ( mRCC)
OligoProgressive Metastatic Disease
Conditions: Official terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Neoplasm Metastasis
Conditions: Keywords:
renal
kidney
mrcc
metastatic
cancer
STING
PULSAR
SABr
SPARK
nivolumab
IMSA 101
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
IMSA101
Description:
All enrolled patients to undergo the following treatment:
SOC treatment: Nivolumab 480 mg monthly PULSAR: 36 Gy in 3 fractions, Q4weeks IMSA101:
five intra-tumoral injections of one of the progressive lesions at 1200 mcg (C1D1, C1D8,
C1D15, C2D1, C3D1)
Arm group label:
SAbR with Intratumoral STING agonist IMSA101 and IO with Anti-PD1
Summary:
To evaluate progression of metastatic renal cell carcinoma from the initiation of PULSAR
radiotherapy in combination with IMSA101 injectable onward.
Detailed description:
The study expects to accrue the 20 patients over a 3-4 year period.
Patients with oligoprogressive disease (1-3 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 5 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients must have metastatic ccRCC.
- Patients must have oligoprogression defined as progression in ≤3 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. Lung metastases are excluded.
- ECOG performance status 0-2.
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Texas Southwestern Medical Center
Address:
City:
Dallas
Zip:
75390
Country:
United States
Contact:
Last name:
BUSAYO ADEFALUJO, CLINICAL RESEARCH COORDINATOR
Phone:
214 648 1873
Email:
Busayo.Adefalujo@UTSouthwestern.edu
Contact backup:
Last name:
SARAH NEUFELD SUPERVISOR OF CLINICAL RESEARCH, MS, MBA
Phone:
214 648 1836
Email:
Sarah.Hardee@UTSouthwestern.edu
Investigator:
Last name:
RAQUIBUL HANNAN, MD
Email:
Principal Investigator
Start date:
December 2024
Completion date:
October 2028
Lead sponsor:
Agency:
University of Texas Southwestern Medical Center
Agency class:
Other
Source:
University of Texas Southwestern Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06601296
