Viewing Study NCT06601296



Ignite Creation Date: 2024-10-25 @ 7:54 PM
Last Modification Date: 2024-10-26 @ 3:40 PM
Study NCT ID: NCT06601296
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-09-11

Brief Title: Radiotherapy in Combination With Checkpoint Inhibition for Patients With Metastatic Kidney Cancer
Sponsor: None
Organization: None

Study Overview

Official Title: STING Agonist and Personalized Ultra-fractionated Stereotactic Adaptive Radiotherapy in Combination With Checkpoint Inhibition for Patients With Metastatic Kidney Cancer SPARK
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: SPARK
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 tissueblood collections

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None