Ignite Creation Date:
2024-05-06 @ 9:56 AM
Last Modification Date:
2024-10-26 @ 12:22 PM
Study NCT ID:
NCT03116529
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-13
First Post:
2017-04-12
Brief Title:
Neoadjuvant Durvalumab and Tremelimumab Plus Radiation for High Risk Soft-Tissue Sarcoma
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Neoadjuvant Anti-PD-L1 DurvalumabMEDI4736 Plus Anti-CTLA-4 Tremelimumab and Radiation for High Risk Soft-Tissue Sarcoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-09
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:
NEXIS
Brief Summary:
Chemotherapy is controversial for soft tissue sarcoma that has not yet metastasized Surgery and radiation are effective for local control but there are no highly effective interventions to prevent metastatic spread of soft tissue sarcoma Immunotherapy has shown promise in other types of cancer Combining two types of immunotherapy agents with preoperative radiation may help the immune system recognize the sarcoma and stimulate an anti-tumor immune response
Detailed Description:
The main purposes of this study are to evaluate the safety tolerability and efficacy of Durvalumab and Tremelimumab in combination with radiation prior to surgical resection of high-risk soft tissue sarcoma in the pelvis and extremities
Patients will receive the same radiation therapy and surgical care they would receive normally and with no change in timing or duration of each treatment They will also receive two immunotherapy agents Durvalumab and Tremelimumab during radiation prior to surgery and a single agent Durvalumab after surgery
Patients will receive the same radiation therapy and surgical care they would receive normally and with no change in timing or duration of each treatment They will also receive two immunotherapy agents Durvalumab and Tremelimumab during radiation prior to surgery and a single agent Durvalumab after surgery
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?:
None
Is an FDA AA801 Violation?:
None