A Phase 2, Open-Label, Randomized Study of Livmoniplimab in Combination with Budigalimab Versus Chemotherapy in Subjects with Metastatic Urothelial Carcinoma

Conditions

Urothelial Carcinoma, Metastatic Urothelial Carcinoma

Brief summary

Overall survival (OS): The time measured from randomization until death from any cause.

Detailed description

Progression-Free survival (PFS): The time measured from randomization until the first documentation of progressive disease according to RECIST 1.1 as determined by investigators or death from any cause, whichever occurs first., Best Overall Response (BOR) of CR/PR: Defined as achieving complete response (CR) or partial response (PR) according to RECIST 1.1 as determined by investigators at any time prior to subsequent anticancer therapy., Duration of Response (DoR): The time from first CR/PR until the first documentation of progressive disease according to RECIST 1.1 as determined by investigators or death from any cause, whichever occurs first.

Related papers

No related papers found yet.

Papers published before 2007-03-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGTAXOTERE 20 mg/1 ml concentrate for solution for infusion

DRUGBudigalimab

DRUGLivmoniplimab

DRUGPaclitaxel 6 mg/mL concentrate for solution for infusion

DRUGGemcitabine 38 mg/mL concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Overall survival (OS): The time measured from randomization until death from any cause.	—

Secondary

Measure	Time frame
Progression-Free survival (PFS): The time measured from randomization until the first documentation of progressive disease according to RECIST 1.1 as determined by investigators or death from any cause, whichever occurs first., Best Overall Response (BOR) of CR/PR: Defined as achieving complete response (CR) or partial response (PR) according to RECIST 1.1 as determined by investigators at any time prior to subsequent anticancer therapy., Duration of Response (DoR): The time from first CR/PR until the first documentation of progressive disease according to RECIST 1.1 as determined by investigators or death from any cause, whichever occurs first.	—

Measure

Time frame

Progression-Free survival (PFS): The time measured from randomization until the first documentation of progressive disease according to RECIST 1.1 as determined by investigators or death from any cause, whichever occurs first., Best Overall Response (BOR) of CR/PR: Defined as achieving complete response (CR) or partial response (PR) according to RECIST 1.1 as determined by investigators at any time prior to subsequent anticancer therapy., Duration of Response (DoR): The time from first CR/PR until the first documentation of progressive disease according to RECIST 1.1 as determined by investigators or death from any cause, whichever occurs first.

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Countries

Belgium, France, Poland, Spain

Outcome results

None listed