Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06632951
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Study to Evaluate Adverse Events and Change in Disease Activity When Intravenously IV Infused Livmoniplimab is Used in Combination With IV Infused Budigalimab in Adult Participants With Urothelial Carcinoma UC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Open-Label Randomized Study of Livmoniplimab in Combination With Budigalimab Versus Chemotherapy in Subjects With Metastatic Urothelial Carcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Urothelial carcinoma UC is the ninth most common cancer type worldwide While the treatment of front-line metastatic urothelial carcinoma mUC has improved there remains a high unmet need for effective therapies for participants who have recurrent disease and disease that has progressed after frontline treatment The purpose of this study is to evaluate the optimized dose adverse events and efficacy of livmoniplimab in combination with budigalimab
Livmoniplimab is an investigational drug being developed for the treatment of mUC There are 3 treatment arms in this study and participants will be randomized in a 111 ratio Participants will either receive livmoniplimab at one of 2 different doses in combination with budigalimab another investigational drug or either docetaxel paclitaxel or gemcitabine based on investigators choice Approximately 150 adult participants will be enrolled in the study across 56 sites worldwide
In arm 1 participants will receive intravenously IV infused livmoniplimab dose A in combination with IV infused budigalimab In arm 2 participants will receive IV infused livmoniplimab dose B in combination with IV infused budigalimab In arm 3 control participants will receive the investigators choice IV infused or injected docetaxel IV infused or injected paclitaxel or IV infused gemcitabine The estimated duration of the study is up to approximately 35 years
There may be higher treatment burden for participants in this trial compared to their standard of care Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments blood tests questionnaires and scans
Livmoniplimab is an investigational drug being developed for the treatment of mUC There are 3 treatment arms in this study and participants will be randomized in a 111 ratio Participants will either receive livmoniplimab at one of 2 different doses in combination with budigalimab another investigational drug or either docetaxel paclitaxel or gemcitabine based on investigators choice Approximately 150 adult participants will be enrolled in the study across 56 sites worldwide
In arm 1 participants will receive intravenously IV infused livmoniplimab dose A in combination with IV infused budigalimab In arm 2 participants will receive IV infused livmoniplimab dose B in combination with IV infused budigalimab In arm 3 control participants will receive the investigators choice IV infused or injected docetaxel IV infused or injected paclitaxel or IV infused gemcitabine The estimated duration of the study is up to approximately 35 years
There may be higher treatment burden for participants in this trial compared to their standard of care Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments blood tests questionnaires and scans
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None