MedTrace Logo

Study to Evaluate Efficacy of PDR001 in Patients With Squamous Cell Carcinoma of the Esophagus

NCT03785496 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2021-05-06

No results posted yet for this study

Summary

Single arm phase II PDR001( 300mg, IV) will be treated every 3 weeks

Conditions

  • Histologically Confirmed Unresectable or Metastatic Squamous Cell Carcinoma of the Esophagus Who Failed on Standard Treatment

Interventions

DRUG

PDR001

PDR001 will be administered once every 3 weeks via i.v. infusions over 30 minutes, respectively. Infusions of each antibody can be extended to up to 2 hours if clinically indicated. A scheduled dose of ongoing study drugs may be delayed by up to 7 days to recover from previous AEs or a missed visit. If a scheduled dose of ongoing study drugs is delayed longer than 7 days due to an unresolved AE, the administration should be skipped and treatment resumed at the next scheduled dose. The assessment schedule will be shifted accordingly.

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Principal Investigators

  • Byoung Chul Cho · Severance Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-18
Primary Completion
2022-01-31
Completion
2024-01-31

Countries

  • South Korea

Study Locations

More Related Trials

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 NCT03785496 on ClinicalTrials.gov