Clinical Trials /

A Study of Cabiralizumab Given With Nivolumab With and Without Chemotherapy in Patients With Advanced Pancreatic Cancer

NCT03336216

Description:

The purpose of this study is to determine whether an investigational immuno-therapy, cabiralizumab in combination with nivolumab, with or without chemotherapy, is effective for the treatment of advanced pancreatic cancer.

Related Conditions:
  • Pancreatic Adenocarcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of Cabiralizumab Given With Nivolumab With and Without Chemotherapy in Patients With Advanced Pancreatic Cancer
  • Official Title: A Phase 2 Study of Cabiralizumab (BMS-986227, FPA008) Administered in Combination With Nivolumab (BMS-936558) With and Without Chemotherapy in Patients With Advanced Pancreatic Cancer

Clinical Trial IDs

  • ORG STUDY ID: CA025-006
  • NCT ID: NCT03336216

Conditions

  • Advanced Pancreatic Cancer

Interventions

DrugSynonymsArms
CabiralizumabBMS-986227, FPA008Arm B
Nab-paclitaxelAbraxaneArm A
Onivydeirinotecan liposomeArm A
NivolumabOpdivo, BMS-936558Arm B
Fluorouracil5-FluorouracilArm A
GemcitabineArm A
OxaliplatinArm D
LeucovorinArm A
Irinotecan HydrochlorideArm A

Purpose

The purpose of this study is to determine whether an investigational immuno-therapy, cabiralizumab in combination with nivolumab, with or without chemotherapy, is effective for the treatment of advanced pancreatic cancer.

Trial Arms

NameTypeDescriptionInterventions
Arm AActive ComparatorInvestigator choice of chemotherapy either gemcitabine/nabpaclitaxel (ABRAXANE) or 5-fluorouracil/leucovorin/irinotecan Liposome (ONIVYDE) ONIVYDE-based regimen can be substituted with FOLFIRI (leucovorin, fluorouracil, irinotecan hydrochloride)
  • Nab-paclitaxel
  • Onivyde
  • Fluorouracil
  • Gemcitabine
  • Leucovorin
  • Irinotecan Hydrochloride
Arm BExperimentalCabiralizumab and Nivolumab
  • Cabiralizumab
  • Nivolumab
Arm CExperimentalcabiralizumab and nivolumab in combination with gemcitabine and abraxane
  • Cabiralizumab
  • Nab-paclitaxel
  • Nivolumab
  • Gemcitabine
Arm DExperimentalcabiralizumab and nivolumab in combination with oxaliplatin/5-Fluorouracil/leucovorin
  • Cabiralizumab
  • Nivolumab
  • Fluorouracil
  • Oxaliplatin
  • Leucovorin

Eligibility Criteria

        Inclusion Criteria:

          -  Must have histological or cytological confirmed diagnosis of locally advanced or
             metastatic adenocarcinoma of the pancreas, which has progressed on or after one line
             of chemotherapy

          -  ECOG Performance status 0-1

          -  Adequate organ functions

          -  Measurable disease

        Exclusion Criteria:

          -  Suspected or known CNS metastasis

          -  Participants with active, known, or suspected autoimmune disease

          -  Uncontrolled or significant cardiovascular disease

          -  Prior exposure to selected immune cell-modulating antibody regimens
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Median progression free survival (mPFS)
Time Frame:Up to 12 months
Safety Issue:
Description:using Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

Secondary Outcome Measures

Measure:Trough observed serum concentration (Ctrough)
Time Frame:Approximately 2 years
Safety Issue:
Description:summary of PK parameters
Measure:Objective response rate (ORR)
Time Frame:Approximately 2 years
Safety Issue:
Description:assessed per RECIST v1.1
Measure:Median duration of response (MDOR)
Time Frame:Approximately 2 years
Safety Issue:
Description:assessed per RECIST v1.1
Measure:Overall survival rate (OSR)
Time Frame:Approximately 2 years
Safety Issue:
Description:
Measure:Incidence of Adverse Events (AE)
Time Frame:Approximately 2 years
Safety Issue:
Description:
Measure:Incidence of Serious Adverse Events (SAE)
Time Frame:Approximately 2 years
Safety Issue:
Description:
Measure:Incidence of death
Time Frame:Approximately 2 years
Safety Issue:
Description:
Measure:Incidence of laboratory abnormalities
Time Frame:Approximately 2 years
Safety Issue:
Description:
Measure:Incidence of Adverse Events (AE) leading to discontinuation
Time Frame:Approximately 2 years
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Bristol-Myers Squibb

Last Updated