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Evaluating Combination Immunotherapy for Advanced Cholangiocarcinoma With Pembrolizumab and PEG-Intron

NCT02982720 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2022-02-16

Study results available
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Summary

This is an open-label, single-arm, multicenter Phase II safety and efficacy study of combination therapy with pembrolizumab and Sylatron (Peginterferon alpha-2b) in patients with advanced cholangiocarcinoma who have progressed on or cannot tolerate frontline chemotherapy.

Conditions

  • Advanced Cholangiocarcinoma

Interventions

DRUG

Pembrolizumab

Pembrolizumab will be administered intravenously.

DRUG

Sylatron

Sylatron will be administered subcutaneously.

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Roswell Park Cancer Institute

    collaborator OTHER

  • The Cleveland Clinic

    collaborator OTHER

  • Georgetown University

    collaborator OTHER

  • Hoosier Cancer Research Network

    collaborator OTHER

  • Aiwu Ruth He, MD

    lead OTHER

Principal Investigators

  • Aiwu R. He, MD PhD · Lombardi Comprehensive Cancer Center Georgetown University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-05
Primary Completion
2018-02-09
Completion
2018-02-09
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT02982720 on ClinicalTrials.gov