Clinical trial NCT06601296: Radiotherapy in Combination With Checkpoint Inhibition for Patients With Metastatic Kidney Cancer
Official title: STING Agonist and Personalized Ultra-fractionated Stereotactic Adaptive Radiotherapy in Combination With Checkpoint Inhibition for Patients With Metastatic Kidney Cancer (SPARK)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Metastatic Renal Cell Carcinoma ( mRCC)
OligoProgressive Metastatic Disease
Keywords: renal
kidney
mrcc
metastatic
cancer
STING
PULSAR
SABr
SPARK
nivolumab
IMSA 101
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
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.
timeFrame: 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 3 months for survival data,up to 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: RAQUIBUL HANNAN, MD
role: PRINCIPAL_INVESTIGATOR
References: