Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-02-25 @ 8:15 PM
Study NCT ID:
NCT03911557
Status:
COMPLETED
Last Update Posted:
2025-11-12
First Post:
2019-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Durvalumab and Tremelimumab Combination in Somatically Hypermutated Recurrent Solid Tumors
Sponsor:
John L. Villano, MD, PhD
Organization:
Study Overview
Official Title:
Phase 2 Investigation of MEDI4736 (Durvalumab) and Tremelimumab Combination in Somatically Hypermutated Recurrent Solid Tumors
Status:
COMPLETED
Status Verified Date:
2025-11
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:
This study will examine whether patients with relapsed/refractory solid tumors harboring evidence of somatic hypermutation (intermediate versus high tumor mutational burden) will exhibit improvement in disease progression-free survival with dual Tremelimumab and Durvalumab treatment.
Detailed Description:
This study is phase II basket trial to evaluate the benefit of immunotherapy (Durvalumab and Tremelimumab combination) in treatment of relapse/refractory solid tumor patients whose tumors express a high tumor mutational burden (TMB high \>20 mutations/MB) or moderate tumor mutational burden (10-20 mutations/MB) as based on next generation sequencing (NGS). The primary endpoint of the study is the TTP (time-to-progression) ratio or growth modulation index (GMI) which is defined for individual patients as the ratio of their TTP on the current therapy to their TTP on the most recent previous therapy.
Study Oversight
Has Oversight DMC:
True
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?: