A Phase 2 Study Evaluating Futibatinib (TAS-120) Plus Pembrolizumab in the Treatment of Advanced or Metastatic Urothelial Carcinoma

Conditions

Advanced or Metastatic Urothelial Carcinoma

Brief summary

Objective response rate (ORR), defined as the proportion of patients experiencing a best overall response of complete response (CR) or partial response (PR).

Detailed description

-Disease control rate (DCR), defined as the proportion of patients experiencing a best overall response of stable disease (SD), PR, or CR., ·Duration of response (DOR), defined as the time from the first documentation of response (CR or PR) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first., ·Progression-free survival (PFS), defined as the time from the first dose of study therapy to the date of death (any cause) or disease progression, whichever occurs first., ·Overall survival (OS), defined as the time from the date of the first dose to the death date., ·Safety and tolerability, based on reported adverse events (AEs) and on-study laboratory parameters, graded according to the National Cancer Institute – Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 5.0.

Related papers

No related papers found yet.

Interventions

DRUGFutibatinib

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Objective response rate (ORR), defined as the proportion of patients experiencing a best overall response of complete response (CR) or partial response (PR).	—

Secondary

Measure	Time frame
-Disease control rate (DCR), defined as the proportion of patients experiencing a best overall response of stable disease (SD), PR, or CR., ·Duration of response (DOR), defined as the time from the first documentation of response (CR or PR) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first., ·Progression-free survival (PFS), defined as the time from the first dose of study therapy to the date of death (any cause) or disease progression, whichever occurs first., ·Overall survival (OS), defined as the time from the date of the first dose to the death date., ·Safety and tolerability, based on reported adverse events (AEs) and on-study laboratory parameters, graded according to the National Cancer Institute – Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 5.0.	—

Measure

Time frame

-Disease control rate (DCR), defined as the proportion of patients experiencing a best overall response of stable disease (SD), PR, or CR., ·Duration of response (DOR), defined as the time from the first documentation of response (CR or PR) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first., ·Progression-free survival (PFS), defined as the time from the first dose of study therapy to the date of death (any cause) or disease progression, whichever occurs first., ·Overall survival (OS), defined as the time from the date of the first dose to the death date., ·Safety and tolerability, based on reported adverse events (AEs) and on-study laboratory parameters, graded according to the National Cancer Institute – Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 5.0.

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Countries

France

Outcome results

None listed