Ignite Creation Date:
2024-05-06 @ 10:19 AM
Last Modification Date:
2024-10-26 @ 12:28 PM
Study NCT ID:
NCT03220854
Status:
COMPLETED
Last Update Posted:
2022-01-10
First Post:
2017-07-14
Brief Title:
SBRT PD-1PDL-1 Inhibiting Therapy for Advanced Solid Tumors After Dz Control on PD-1PDL-1 Tx
Sponsor:
Virginia Commonwealth University
Organization:
Virginia Commonwealth University
Study Overview
Official Title:
Phase 2 Clinical Trial of Stereotactic Radiotherapy SRT and PD-1 or PD-L1 Inhibiting Therapy for Treatment of Advanced Solid Tumors After Disease Control on PD-1 or PD-L1 Inhibiting Therapy
Status:
COMPLETED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to find out if having radiation therapy and continuing immunotherapy can improve the benefit of immunotherapy There have been reports of patients who were treated with radiation therapy that not only caused the treated tumors to shrink or stop growing but also resulted in tumors that had not been treated in other parts of the body to shrink or stop growing This effect is thought to be brought about by cells in the bodys immune system that become active as a result of the effects of radiation therapy If radiation therapy can stimulate the immune system it may be possible for immunotherapy to be helpful again in treating a cancer that the immunotherapy drug helped treat before This study will also check if receiving immunotherapy at the end of radiation therapy has any effect on the side effects of radiation therapy or immunotherapy
Detailed Description:
Stereotactic radiotherapy SRT will be delivered in up to 10 treatment fractions over 1 to 2 weeks Patients will continue to receive the same FDA-approved programmed death receptor-1 PD-1 or programmed death-ligand 1 PD-L1 inhibitor that they had been receiving at the time of disease progression through 52 weeks following completion of SRT
Correlative blood samples will be collected at baseline prior to the second SRT fraction after the last SRT fraction on the same day and at 8 24 and 52 weeks after the last SRT fraction These samples will be used to determine the mechanistic immunologic effects of therapy
Correlative blood samples will be collected at baseline prior to the second SRT fraction after the last SRT fraction on the same day and at 8 24 and 52 weeks after the last SRT fraction These samples will be used to determine the mechanistic immunologic effects of therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA016059 | NIH | None | httpsreporternihgovquickSearchP30CA016059 |