DEPECA-1 – DEfeating PEnile CAncer 1 – A Phase II study to evaluate a first-line systemic therapy with enfortumab vedotin plus avelumab for advanced and metastatic penile carcinoma

Conditions

locally advanced or metastatic penile squamous cell carcinoma

Brief summary

Objective Response Rate (ORR) in 1st line as assessed by investigators, defined as the proportion of patients achieving a complete response (CR) or partial response (PR) according to RECIST 1.1 criteria.

Detailed description

Progression-free survival (PFS), defined as the time from the start of treatment to the first documented disease progression acc. to RECIST 1.1 criteria or death from any cause, whichever occurs first., Overall Survival (OS), defined as the time from the start of treatment to death from any cause., Duration of Response (DoR), defined as the time from the first documented response (CR or PR) to disease progression or death from any cause, whichever occurs first., Disease Control Rate (DCR), defined as the proportion of patients achieving CR, PR, or stable disease (SD) for at least 12 weeks according to RECIST 1.1 criteria., Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0., Changes in patient-reported quality of life, using EQ-5D-5L and EQ-HWB-S questionnaire and a set of bolt-on questions will be collected.

Related papers

No related papers found yet.

Interventions

DRUGBavencio 20 mg/mL concentrate for solution for infusion

DRUGPadcev 30 mg powder for concentrate for solution for infusion

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Objective Response Rate (ORR) in 1st line as assessed by investigators, defined as the proportion of patients achieving a complete response (CR) or partial response (PR) according to RECIST 1.1 criteria.	—

Secondary

Measure	Time frame
Progression-free survival (PFS), defined as the time from the start of treatment to the first documented disease progression acc. to RECIST 1.1 criteria or death from any cause, whichever occurs first., Overall Survival (OS), defined as the time from the start of treatment to death from any cause., Duration of Response (DoR), defined as the time from the first documented response (CR or PR) to disease progression or death from any cause, whichever occurs first., Disease Control Rate (DCR), defined as the proportion of patients achieving CR, PR, or stable disease (SD) for at least 12 weeks according to RECIST 1.1 criteria., Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0., Changes in patient-reported quality of life, using EQ-5D-5L and EQ-HWB-S questionnaire and a set of bolt-on questions will be collected.	—

Measure

Time frame

Progression-free survival (PFS), defined as the time from the start of treatment to the first documented disease progression acc. to RECIST 1.1 criteria or death from any cause, whichever occurs first., Overall Survival (OS), defined as the time from the start of treatment to death from any cause., Duration of Response (DoR), defined as the time from the first documented response (CR or PR) to disease progression or death from any cause, whichever occurs first., Disease Control Rate (DCR), defined as the proportion of patients achieving CR, PR, or stable disease (SD) for at least 12 weeks according to RECIST 1.1 criteria., Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0., Changes in patient-reported quality of life, using EQ-5D-5L and EQ-HWB-S questionnaire and a set of bolt-on questions will be collected.

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Countries

Germany

Outcome results

None listed