Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06370871
Status:
WITHDRAWN
Last Update Posted:
2024-05-14
First Post:
2024-04-15
Brief Title:
Brightline-3 A Study to Find Out Whether Brigimadlin in Combination With Ezabenlimab Helps People With Advanced Soft Tissue Sarcoma
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
Brightline-3 A Phase III Randomized Open-label Multi-center Trial of Brigimadlin Ezabenlimab Compared to Gemcitabine Docetaxel for Second-line Treatment of Patients With Advanced TP53 Wild-type Soft Tissue Sarcoma Subtypes
Status:
WITHDRAWN
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is open to adults with specific types of advanced soft tissue sarcoma People with undifferentiated pleomorphic sarcoma UPS or myxofibrosarcoma MFS can join the study if they have a normal version of the TP53 gene This is a study for people whose earlier treatment isnt working anymore and their doctors suggest a new treatment to stop the sarcoma from getting worse
The purpose of this study is to compare a medicine called brigimadlin in combination with another medicine called ezabenlimab with chemotherapy Brigimadlin is a so-called MDM2-p53 antagonist that is being developed to treat cancer Ezabenlimab is an antibody that may help the immune system fight cancer
Participants are put into 3 groups by chance
Ezabenlimab group Participants receive ezabenlimab as an infusion into a vein every 3 weeks
Brigimadlin ezabenlimab group Participants take brigimadlin as tablets and receive ezabenlimab as an infusion into a vein every 3 weeks
Chemotherapy group Participants get chemotherapy as an infusion into a vein on 2 days every 3 weeks Chemotherapy is a combination of gemcitabine and docetaxel which is often used in the treatment of sarcoma
There are twice as many participants in the brigimadlin ezabenlimab group and in the chemotherapy group compared to those in the ezabenlimab group
Participants can continue treatment in the study as long as they benefit from it and can tolerate it
Doctors regularly check the size of the tumor and check whether it has spread to other parts of the body The doctors also regularly check participants health and take note of any unwanted effects Participants in this study use an app on a mobile phone to regularly answer questions about their health and well-being This is to find out if their quality of life is changing
The purpose of this study is to compare a medicine called brigimadlin in combination with another medicine called ezabenlimab with chemotherapy Brigimadlin is a so-called MDM2-p53 antagonist that is being developed to treat cancer Ezabenlimab is an antibody that may help the immune system fight cancer
Participants are put into 3 groups by chance
Ezabenlimab group Participants receive ezabenlimab as an infusion into a vein every 3 weeks
Brigimadlin ezabenlimab group Participants take brigimadlin as tablets and receive ezabenlimab as an infusion into a vein every 3 weeks
Chemotherapy group Participants get chemotherapy as an infusion into a vein on 2 days every 3 weeks Chemotherapy is a combination of gemcitabine and docetaxel which is often used in the treatment of sarcoma
There are twice as many participants in the brigimadlin ezabenlimab group and in the chemotherapy group compared to those in the ezabenlimab group
Participants can continue treatment in the study as long as they benefit from it and can tolerate it
Doctors regularly check the size of the tumor and check whether it has spread to other parts of the body The doctors also regularly check participants health and take note of any unwanted effects Participants in this study use an app on a mobile phone to regularly answer questions about their health and well-being This is to find out if their quality of life is changing
Detailed Description:
None
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 |
|---|---|---|---|
| 2022-502985-26-00 | REGISTRY | None | None |
| U1111-1292-9594 | REGISTRY | WHO Registry | None |