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Safety and Tolerability Study of Nivolumab and Cabiralizumab for Resectable Biliary Tract Cancer

NCT03768531

Description:

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).

Related Conditions:
  • Biliary Tract Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Safety and Tolerability Study of Nivolumab and Cabiralizumab for Resectable Biliary Tract Cancer
  • Official Title: Safety and Tolerability Study of Combination Nivolumab and Cabiralizumab as Neoadjuvant and Adjuvant Therapy for Resectable Biliary Tract Cancer

Clinical Trial IDs

  • ORG STUDY ID: J18162
  • SECONDARY ID: IRB00185328
  • NCT ID: NCT03768531

Conditions

  • Resectable Biliary Tract Cancer

Interventions

DrugSynonymsArms
NivolumabOPDIVO; BMS-936558-01Arm A: Nivolumab
CabrilizumabFPA008, BMS-986227Arm B: Nivolumab and Cabrilizumab

Purpose

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 Arms

NameTypeDescriptionInterventions
Arm A: NivolumabExperimental
  • Nivolumab
Arm B: Nivolumab and CabrilizumabExperimentalNivolumab 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).
  • Nivolumab
  • Cabrilizumab

Eligibility Criteria

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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.
      
Maximum Eligible Age:100 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of participants experiencing study drug-related toxicities
Time Frame:4 years
Safety Issue:
Description:Number of participants experiencing drug-related adverse events as defined by CTCAE v5.0

Secondary Outcome Measures

Measure:Overall survival (OS)
Time Frame:4 years
Safety Issue:
Description:Number of months from the date of first treatment until death or end of follow-up.
Measure:Disease free survival (DFS)
Time Frame:up to 4 years
Safety Issue:
Description:Number of months until disease recurrence.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Trial Keywords

  • Nivolumab
  • Cabiralizumab
  • Immunotherapy
  • Anti-PD-1
  • Anti-CSF-1R
  • Biliary tract cancers (BTC)
  • Neoadjuvant chemotherapy
  • Adjuvant chemotherapy
  • Tumor microenvironment

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