Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04874311
Status:
RECRUITING
Last Update Posted:
2023-09-28
First Post:
2021-05-04
Brief Title:
Bintrafusp Alfa and Doxorubicin Hydrochloride in Treating Patients With Advanced Sarcoma
Sponsor:
Institut Bergonié
Organization:
Institut Bergonié
Study Overview
Official Title:
Bintrafusp Alfa and Doxorubicin Hydrochloride in Treating Patients With Advanced Sarcoma TRUST Study
Status:
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:
TRUST
Brief Summary:
This study encompasses two multicenter prospective open-labeled 2-arm non-comparative randomized phase II trials to assess the antitumor activity of bintrafusp alfa in association with doxorubicin
Detailed Description:
This is a two multicenter prospective open-labeled 2-arm non-comparative randomized 21 phase II trials
Patients satisfying eligibility criteria will first be stratified into 2 strata subgroups
Soft-tissue sarcoma STS patients with an inflamed tumor ie TLS defined as presence of mature tertiary lymphoid structures as per IHC
Soft-tissue sarcoma patients with a cold tumor ie TLS- defined as absence of mature tertiary lymphoid structures as per IHC
Note TLS and TLS- account for 20 and 80 of STS patients respectively
STS patients with TLS will be randomized between arm A bintrafusp alfa combined with doxorubicin for 6 cycles followed by bintrafusp alfa maintenance and arm B doxorubicin for 6 cycles with two patients randomized in arm A for one patient randomized in arm B
STS patients with TLS- will be randomized between arm C bintrafusp alfa combined with doxorubicin for 6 cycles followed by bintrafusp alfa maintenance and arm D doxorubicin for 6 cycles with two patients randomized in arm C for one patient randomized in arm D
Patients satisfying eligibility criteria will first be stratified into 2 strata subgroups
Soft-tissue sarcoma STS patients with an inflamed tumor ie TLS defined as presence of mature tertiary lymphoid structures as per IHC
Soft-tissue sarcoma patients with a cold tumor ie TLS- defined as absence of mature tertiary lymphoid structures as per IHC
Note TLS and TLS- account for 20 and 80 of STS patients respectively
STS patients with TLS will be randomized between arm A bintrafusp alfa combined with doxorubicin for 6 cycles followed by bintrafusp alfa maintenance and arm B doxorubicin for 6 cycles with two patients randomized in arm A for one patient randomized in arm B
STS patients with TLS- will be randomized between arm C bintrafusp alfa combined with doxorubicin for 6 cycles followed by bintrafusp alfa maintenance and arm D doxorubicin for 6 cycles with two patients randomized in arm C for one patient randomized in arm D
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-005703-39 | EUDRACT_NUMBER | None | None |