Last reviewed · How we verify

NCT02982720

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

Terminated Phase 2 Results posted Last updated 16 February 2022
What this trial tests

Phase 2 trial testing Pembrolizumab in Advanced Cholangiocarcinoma in 4 participants. Terminated before completion.

Timeline
5 July 2017
Primary endpoint
9 February 2018
9 February 2018

Quick facts

Lead sponsorAiwu Ruth He, MD
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment4
Start date5 July 2017
Primary completion9 February 2018
Estimated completion9 February 2018
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Aiwu Ruth He, MD — full company profile →

Who can join

18 and older, any sex, with Advanced Cholangiocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Pembrolizumab and Sylatron
Serious: 4/4 (100%)
Deaths: 1/4

Serious adverse events (4 terms)

ReactionSystemPembrolizumab and Sylatron
ALANINE AMINOTRANSFERASE INCREASEDInvestigations—
FEVERGeneral disorders—
ASPARTATE AMINOTRANSFERASE INCREASEDInvestigations—
BLOOD BILIRUBIN INCREASEDInvestigations—
Other adverse events (23 terms — click to expand)

ReactionSystemPembrolizumab and Sylatron
ASPARTATE AMINOTRANSFERASE INCREASEDInvestigations—
FATIGUEGeneral disorders—
ALKALINE PHOSPHATASE INCREASEDInvestigations—
HYPOALBUMINEMIAMetabolism and nutrition disorders—
ALANINE AMINOTRANSFERASE INCREASEDInvestigations—
ANEMIABlood and lymphatic system disorders—
ABDOMINAL PAINGastrointestinal disorders—
ANOREXIAMetabolism and nutrition disorders—
BLOOD BILIRUBIN INCREASEDInvestigations—
BLURRED VISIONEye disorders—
DIARRHEAGastrointestinal disorders—
ENDOCRINE DISORDERSEndocrine disorders—
GLAUCOMAEye disorders—
HYPERGLYCEMIAMetabolism and nutrition disorders—
HYPERTHYROIDISMEndocrine disorders—
HYPOPHOSPHATEMIAMetabolism and nutrition disorders—
NAUSEAGastrointestinal disorders—
NECK PAINMusculoskeletal and connective tissue disorders—
NEUTROPHIL COUNT DECREASEDInvestigations—
PAINGeneral disorders—
PRURITUSSkin and subcutaneous tissue disorders—
SKIN AND SUBCUTANEOUS TISSUE DISORDERSSkin and subcutaneous tissue disorders—
WHITE BLOOD CELL DECREASEDInvestigations—

Most-reported serious reactions: ALANINE AMINOTRANSFERASE INCREASED, FEVER, ASPARTATE AMINOTRANSFERASE INCREASED, BLOOD BILIRUBIN INCREASED.

Data from ClinicalTrials.gov NCT02982720 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Cholangiocarcinoma - evolving concepts and therapeutic strategies.
    Ilyas SI, Khan SA, Hallemeier CL, Kelley RK, et al · · 2018 · cited 1192× · PMID 28994423 · DOI 10.1038/nrclinonc.2017.157
  2. Immunobiology of cholangiocarcinoma.
    Loeuillard E, Conboy CB, Gores GJ, Ilyas SI. · · 2019 · cited 88× · PMID 32039381 · DOI 10.1016/j.jhepr.2019.06.003
  3. Clinical Application of Cytokines in Cancer Immunotherapy.
    Qiu Y, Su M, Liu L, Tang Y, et al · · 2021 · cited 76× · PMID 34079226 · DOI 10.2147/dddt.s308578
  4. Trial Watch: Immunostimulation with recombinant cytokines for cancer therapy.
    García-Martínez E, Smith M, Buqué A, Aranda F, et al · · 2018 · cited 38× · PMID 29872569 · DOI 10.1080/2162402x.2018.1433982
  5. Immunotherapy in Advanced Biliary Tract Cancers.
    Boilève A, Hilmi M, Smolenschi C, Ducreux M, et al · · 2021 · cited 32× · PMID 33805461 · DOI 10.3390/cancers13071569
  6. Biliary Tract Cancers: Treatment Updates and Future Directions in the Era of Precision Medicine and Immuno-Oncology.
    Manne A, Woods E, Tsung A, Mittra A. · · 2021 · cited 29× · PMID 34868996 · DOI 10.3389/fonc.2021.768009
  7. Combination therapy with PD-1/PD-L1 blockade: An overview of ongoing clinical trials.
    Johnson CB, Win SY. · · 2018 · cited 26× · PMID 29632719 · DOI 10.1080/2162402x.2017.1408744
  8. Application of Immune Checkpoint Inhibitors in the Treatment of Cholangiocarcinoma.
    Zeng FL, Chen JF. · · 2021 · cited 24× · PMID 34528830 · DOI 10.1177/15330338211039952

Verify or expand the search:

Other trials of Pembrolizumab

Trials testing the same drug.

Other recruiting trials for Advanced Cholangiocarcinoma

Currently open trials in the same condition.

Other Aiwu Ruth He, MD trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02982720.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing