NCT03768531

Brief Summary

The purposed of this research is to study the safety and clinical activity of the combination of nivolumab and cabiralizumab in people with resectable biliary tract cancers (BTC).

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2019

Typical duration for phase_2

Status
withdrawn

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

December 5, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 7, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

June 14, 2019

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

April 13, 2020

Status Verified

April 1, 2020

Enrollment Period

3.6 years

First QC Date

December 5, 2018

Last Update Submit

April 9, 2020

Conditions

Resectable Biliary Tract Cancer

Keywords

NivolumabCabiralizumabImmunotherapyAnti-PD-1Anti-CSF-1RBiliary tract cancers (BTC)Neoadjuvant chemotherapyAdjuvant chemotherapyTumor microenvironment

Outcome Measures

Primary Outcomes (1)

  • Number of participants experiencing study drug-related toxicities

    Number of participants experiencing drug-related adverse events as defined by CTCAE v5.0

    4 years

Secondary Outcomes (2)

  • Overall survival (OS)

    4 years

  • Disease free survival (DFS)

    up to 4 years

Study Arms (2)

Arm A: Nivolumab

EXPERIMENTAL
Drug: Nivolumab

Arm B: Nivolumab and Cabrilizumab

EXPERIMENTAL

Nivolumab 3 mg/kg will be given intravenously (IV) through a vein in the arm over 30 minutes, a 30 minute rest, followed by cabiralizumab every 2 weeks. (Cycle length 2 weeks).

Drug: NivolumabDrug: Cabrilizumab

Interventions

NivolumabDRUG

Nivolumab 3 mg/kg will be given intravenously (IV) through a vein in the arm over 30 minutes every 2 weeks. (Cycle length 2 weeks).

Also known as: OPDIVO; BMS-936558-01
Arm A: NivolumabArm B: Nivolumab and Cabrilizumab
CabrilizumabDRUG

Cabiralizumab 4 mg/kg given IV for 30 minutes, 30 minutes after Nivolumab infusion is completed, every 2 weeks. (Cycle length 2 weeks).

Also known as: FPA008, BMS-986227
Arm B: Nivolumab and Cabrilizumab

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Has confirmed biliary tract cancer
  • Ability to understand and willingness to sign a written informed consent document.
  • Age ≥18 years
  • Have biopsiable disease
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Patient must have adequate organ function defined by the study-specified laboratory tests.
  • Must use acceptable form of birth control while on study.

You may not qualify if:

  • Has active autoimmune disease that requires systemic treatment.
  • Has a known additional malignancy that is progressing or has required active treatment within the past 2 years or that is expected to require active treatment within two years.
  • Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, etc.).
  • Has known central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
  • Has evidence of an uncontrolled, active infection requiring parenteral anti-bacterial, anti-viral or anti-fungal therapy ≤ 7 days prior to administration of study medication.
  • Has received a blood transfusion within 72 hours prior to first dose of study drug administration
  • Unwilling or unable to follow the study schedule for any reason.
  • Major surgery within 4 weeks prior to initiation of study treatment.
  • Patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant muscle disorders or psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant or breastfeeding women.
  • Have known history of infection with HIV, hepatitis B, or hepatitis C.
  • Received any prophylactic vaccine within 30 days of first dose of study drug treatment.
  • Has a history of allergy to study treatments or any of its components of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsBiliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Adrian Murphy, MD

    Johns Hopkins Medical Institution

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2018

First Posted

December 7, 2018

Study Start

June 14, 2019

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

April 13, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share