Multicenter, open label, single arm, phase II study to assess the efficay and safety of enfortumab-vedotin (EV) as a single agent in patients with advanced Neuroendocrine Carcinomas (NEC) refractory or ineligible to platinum-containing chemotherapy

Conditions

Neuroendocrine Carcinoma / G3 Neuroendocrine Tumours

Brief summary

Objective response rate (ORR) according to RECIST v1.1.

Detailed description

Progression-free survival (PFS): The time from the start of the first dose of the study treatment to the first objective documentation of tumour progression or death from any cause., Duration of response (DOR): The time from the first documentation of confirmed objective response (CR or PR) to the first objective documentation of tumour progression or death due to any reason., Overall survival (OS): The time from the start of the first dose of the study treatment to death due to any reason., Absolute and relative frequencies of patients experiencing adverse events (AEs), patients experiencing serious adverse events (SAEs), patients experiencing adverse reactions (ARs), patients experiencing serious adverse reactions (SARs) and patients experiencing suspected unexpected serious adverse reactions (SUSARs). Absolute frequencies of recorded AEs, recorded SAEs, recorded ARs, recorded SARs and recorded SUSARs., Exploratory variables: Expression levels of nectin-4 determined by immunohistochemistry in the tumour block of the diagnostic biopsy.

Related papers

No related papers found yet.

Interventions

DRUGPadcev 30 mg powder for concentrate for solution for infusion

DRUGPadcev 20 mg powder for 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) according to RECIST v1.1.	—

Secondary

Measure	Time frame
Progression-free survival (PFS): The time from the start of the first dose of the study treatment to the first objective documentation of tumour progression or death from any cause., Duration of response (DOR): The time from the first documentation of confirmed objective response (CR or PR) to the first objective documentation of tumour progression or death due to any reason., Overall survival (OS): The time from the start of the first dose of the study treatment to death due to any reason., Absolute and relative frequencies of patients experiencing adverse events (AEs), patients experiencing serious adverse events (SAEs), patients experiencing adverse reactions (ARs), patients experiencing serious adverse reactions (SARs) and patients experiencing suspected unexpected serious adverse reactions (SUSARs). Absolute frequencies of recorded AEs, recorded SAEs, recorded ARs, recorded SARs and recorded SUSARs., Exploratory variables: Expression levels of nectin-4 determined by immunohistoche	—

Measure

Time frame

Progression-free survival (PFS): The time from the start of the first dose of the study treatment to the first objective documentation of tumour progression or death from any cause., Duration of response (DOR): The time from the first documentation of confirmed objective response (CR or PR) to the first objective documentation of tumour progression or death due to any reason., Overall survival (OS): The time from the start of the first dose of the study treatment to death due to any reason., Absolute and relative frequencies of patients experiencing adverse events (AEs), patients experiencing serious adverse events (SAEs), patients experiencing adverse reactions (ARs), patients experiencing serious adverse reactions (SARs) and patients experiencing suspected unexpected serious adverse reactions (SUSARs). Absolute frequencies of recorded AEs, recorded SAEs, recorded ARs, recorded SARs and recorded SUSARs., Exploratory variables: Expression levels of nectin-4 determined by immunohistoche

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Countries

Spain

Outcome results

None listed