A Phase 2 Study of Cabiralizumab Administered in Combination with Nivolumab with and without Chemotherapy in Patients with Advanced Pancreatic Cancer.
Phase 1
- Conditions
- Advanced Pancreatic Cancer.MedDRA version: 21.0Level: LLTClassification code 10033604Term: Pancreatic cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2018-000339-28-IT
- Lead Sponsor
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
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
_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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method