A Phase 2 Study of Cabiralizumab Administered in Combination with Nivolumab with and without Chemotherapy in Patients with Advanced Pancreatic Cancer.

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

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-000339-28-GB

Enrollment

200

Registered

2018-08-08

Start date

2018-10-01

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Pancreatic Cancer. MedDRA version: 21.0 Level: LLT Classification code 10033604 Term: Pancreatic cancer System Organ Class: 100000004864

Interventions

Product Name: Cabiralizumab 100mg/vial Product Code: BMS-986227 Pharmaceutical Form: Solution for injection INN or Proposed INN: CABIRALIZUMAB

Anti-CSF1R mAb Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Trade Name: Opdivo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: _Must have histological or cytological confirmed diagnosis of locally advanced or metastatic adenocarcinoma of the pancreas, who progressed on or after one line of chemotherapy; _ECOG Performance status 0-1; _Adequate organ functions; _Measurable disease. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the PFS of cabiralizumab administered in combination with nivolumab with and without chemotherapy relative to investigator’s choice of chemotherapy in participants with advanced/metastatic pancreatic cancer who progressed on or after the first line of chemotherapy (either gemcitabine-based or 5-fluorouracil (5-FU)-based chemotherapy). ; Secondary Objective: _To assess the safety of cabiralizumab administered in combination with nivolumab with and without chemotherapy in participants with advanced/metastatic pancreatic cancer who progressed on or after the first line of chemotherapy (either gemcitabine-based or 5-FU-based chemotherapy); _To characterize the pharmacokinetics (PK) of cabiralizumab administered in combination with nivolumab with and without chemotherapy; _To evaluate the anti-tumor activity of cabiralizumab administered in combination with nivolumab with and without chemotherapy relative to investigator’s choice of chemotherapy in participants with advanced/metastatic pancreatic cancer who progressed on or after the first line of chemotherapy (either gemcitabine-based or 5-FU-based chemotherapy) using RECIST v1.1; _To assess overall survival rate (OSR). ;Primary end point(s): • PFS per RECIST v1.1 by BICR.;Timepoint(s) of evaluation of this end point: Up to 12 months.	—

Measure

Time frame

Main Objective: To evaluate the PFS of cabiralizumab administered in combination with nivolumab with and without chemotherapy relative to investigator’s choice of chemotherapy in participants with advanced/metastatic pancreatic cancer who progressed on or after the first line of chemotherapy (either gemcitabine-based or 5-fluorouracil (5-FU)-based chemotherapy). ; Secondary Objective: _To assess the safety of cabiralizumab administered in combination with nivolumab with and without chemotherapy in participants with advanced/metastatic pancreatic cancer who progressed on or after the first line of chemotherapy (either gemcitabine-based or 5-FU-based chemotherapy); _To characterize the pharmacokinetics (PK) of cabiralizumab administered in combination with nivolumab with and without chemotherapy; _To evaluate the anti-tumor activity of cabiralizumab administered in combination with nivolumab with and without chemotherapy relative to investigator’s choice of chemotherapy in participants with advanced/metastatic pancreatic cancer who progressed on or after the first line of chemotherapy (either gemcitabine-based or 5-FU-based chemotherapy) using RECIST v1.1; _To assess overall survival rate (OSR). ;Primary end point(s): • PFS per RECIST v1.1 by BICR.;Timepoint(s) of evaluation of this end point: Up to 12 months.

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Secondary

Measure	Time frame
Secondary end point(s): • PFS per RECIST v1.1 by investigator assessment; ORR, DOR, and PFSR per RECIST v1.1 by BICR and investigator assessment; • OS and OSR; • Incidence of AEs, SAEs, AEs leading to discontinuation, death, and laboratory abnormalities. ;Timepoint(s) of evaluation of this end point: Up to 2 years.	—

Countries

Canada, Denmark, Finland, Germany, Italy, Japan, Korea, Republic of, Norway, Spain, Sweden, Taiwan, United Kingdom, United States

Contacts

Public ContactGCT-SU

Bristol-Myers Squibb International Corporation

clinical.trials@bms.com900 150 160

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026