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Pembrolizumab for the Treatment of Recurrent High Grade Neuroendocrine Carcinoma

NCT03190213 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2021-06-22

Study results available
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Summary

This is an open label, non-randomized phase 2 study to assess overall response rate (ORR), clinical benefit rate (CBR), overall survival (OS) and progression free survival (PFS) in patients with high grade neuroendocrine tumors treated with pembrolizumab 200mg Q 3 Weeks.

Conditions

Interventions

DRUG

Pembrolizumab Injection

Pembrolizumab at a dose of 200 mg will be administered as an IV infusion over 30 minutes every 3 weeks until disease recurrence or discontinuation due to unacceptable toxicity for a maximum of 2 years. We anticipate on average patients will remain on treatment for approximately 24 weeks.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-04
Primary Completion
2018-12-13
Completion
2019-03-11
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03190213 on ClinicalTrials.gov