NCT03046862

Brief Summary

\<Research Hypothesis\> The dynamics of immune systems by cytotoxic chemotherapy and its changes by combination with immuno-oncology agents will be uncovered. The combination of Durvalumab/Tremelimumab with gemcitabine/cisplatin chemotherapy is feasible and efficacious in chemo-naïve biliary tract cancer. \<Purpose of the study\> To assess the effect of Durvalumab/Tremelimumab in combination with gemcitabine/cisplatin on response rate (RR) in chemo-naïve advanced biliary tract cancer patients.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
31

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2017

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 8, 2017

Completed
17 days until next milestone

Study Start

First participant enrolled

February 25, 2017

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2020

Completed
4.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

April 19, 2024

Status Verified

April 1, 2024

Enrollment Period

3.3 years

First QC Date

February 6, 2017

Last Update Submit

April 17, 2024

Conditions

Biliary Tract Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Response rate

    According to RECIST v1.1 criteria

    6 weeks

Secondary Outcomes (7)

  • Disease control rate

    6 weeks

  • Progression-free survival

    6 weeks

  • Duration of response

    1 year

  • Overall survival

    1 year

  • Quality-of-life as measured by EORTC QLQ-BIL21

    1 year

  • +2 more secondary outcomes

Study Arms (1)

Durvalumab/Tremelimumab+chemotherapy

EXPERIMENTAL

Durvalumab and Tremelimumab in combination with gemcitabine/cisplatin.

Drug: DurvalumabDrug: TremelimumabDrug: GemcitabineDrug: Cisplatin

Interventions

DurvalumabDRUG

Durvalumab 1.12 g iv on D1 every 3 weeks

Also known as: MEDI4736
Durvalumab/Tremelimumab+chemotherapy
TremelimumabDRUG

Tremelimumab 75mg iv on D1 every 3 weeks

Durvalumab/Tremelimumab+chemotherapy
GemcitabineDRUG

Gemcitabine 1000 mg/m2 iv on D1\& D8 every 3 weeks

Durvalumab/Tremelimumab+chemotherapy
CisplatinDRUG

Cisplatin 25 mg/m2 iv on D1\& D8 every 3 weeks

Durvalumab/Tremelimumab+chemotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically proven BTC, including intrahepatic cholangiocarcinoma, extrahepatic bile duct cancer, gallbladder cancer, ampulla of vater cancer
  • Unresectable or recurrent
  • chemotherapy -naïve for their unresectable or recurrent cancer (Previous expose to adjuvant chemotherapy is allowed)
  • should have measurable lesion
  • ECOG 0, 1
  • Without previous expose to immune-oncology agents including anti-CTLA4, anti-PD1, anti-PDL1, etc
  • Adequate organ function
  • : ANC\>1500/mm3, platelet\>100K/mm3, HgB\>9 g/Dl, bilirubin\<1.5 x ULN, ALT/AST\<2.5 X UNL, (in case of liver metastasis, \<5 Xunl), Cr\<1.5 mg/Dl
  • Informed consent

You may not qualify if:

  • Previous treatment for unresectable or recurrent cancer
  • Under immunosuppressive agents higher than equivalent dose of prednisone 10mg/day
  • Uncontrolled disease such as current active infection, congestive heart failure, uncontrolled hypertension, unstable angina, arrhythmia, interstitial lung disease
  • Current active pulmonary tuberculosis
  • Current active hepatitis B or hepatitis C (simple carrier is allowed)
  • anti-HIV (+)
  • Pregnant, breast-feeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (1)

  • Oh DY, Lee KH, Lee DW, Yoon J, Kim TY, Bang JH, Nam AR, Oh KS, Kim JM, Lee Y, Guthrie V, McCoon P, Li W, Wu S, Zhang Q, Rebelatto MC, Kim JW. Gemcitabine and cisplatin plus durvalumab with or without tremelimumab in chemotherapy-naive patients with advanced biliary tract cancer: an open-label, single-centre, phase 2 study. Lancet Gastroenterol Hepatol. 2022 Jun;7(6):522-532. doi: 10.1016/S2468-1253(22)00043-7. Epub 2022 Mar 9.

    PMID: 35278356DERIVED

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

durvalumabtremelimumabGemcitabineCisplatin

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsBiliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Do-Youn Oh, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 6, 2017

First Posted

February 8, 2017

Study Start

February 25, 2017

Primary Completion

May 30, 2020

Study Completion

December 31, 2024

Last Updated

April 19, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)