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
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