Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06340568
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-03-25
Brief Title:
A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients with Recurring Uterine Cancer
Sponsor:
BioNTech SE
Organization:
BioNTech SE
Study Overview
Official Title:
A Phase III Randomized Multi-site Open-label Trial of BNT323DB-1303 Versus Investigators Choice of Chemotherapy in Previously Treated Patients with HER2- Expressing Recurrent Endometrial Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
The goal of this clinical study is to assess the efficacy of BNT323DB-1303 compared with investigators choice of chemotherapy in terms of progression-free survival PFS by blinded independent central review BICR in the endometrial cancer population
Detailed Description:
This is an open-label randomized multi-site Phase III interventional clinical study designed to determine the efficacy and safety of BNT323DB-1303 compared with investigators choice of single agent chemotherapy in previously treated patients with recurrent endometrial cancer whose disease has progressed on at least one line of platinum-based therapy
Owing to the differences in availability of immune checkpoint inhibitors ICIs between countries there will be two cohorts in the study
Cohort 1 main cohort Patients that have had prior ICI treatment
Cohort 2 China only Patients that have not had prior ICI treatment
In each cohort patients will be randomized 21 to receive either BNT323DB-1303 or investigators choice of single agent chemotherapy doxorubicin or paclitaxel until Response Evaluation Criteria in Solid Tumors RECIST 11 defined progressive disease PD unless there is unacceptable toxicity withdrawal of consent or another criterion for discontinuation is met
Owing to the differences in availability of immune checkpoint inhibitors ICIs between countries there will be two cohorts in the study
Cohort 1 main cohort Patients that have had prior ICI treatment
Cohort 2 China only Patients that have not had prior ICI treatment
In each cohort patients will be randomized 21 to receive either BNT323DB-1303 or investigators choice of single agent chemotherapy doxorubicin or paclitaxel until Response Evaluation Criteria in Solid Tumors RECIST 11 defined progressive disease PD unless there is unacceptable toxicity withdrawal of consent or another criterion for discontinuation is met
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ENGOT- en25NSGO-CTU | OTHER | European Network for Gynaecological Oncological Trial groups ENGOT | None |
| GOG-3105 | OTHER | None | None |
| 2023-507525-42-00 | OTHER | None | None |