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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Advanced Pancreatic Cancer

Intervention / Treatment
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* Biological: Cabiralizumab
* Drug: Nab-paclitaxel
* Drug: Onivyde
* Biological: Nivolumab
* Drug: Fluorouracil
* Drug: Gemcitabine
* Drug: Oxaliplatin
* Drug: Leucovorin
* Drug: Irinotecan Hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm A<br>Investigator choice of chemotherapy: Gemcitabine/Nab-Paclitaxel (Abraxane®) or 5-Fluorouracil/Leucovorin/Irinotecan Liposome (ONIVYDE) | Drug: Nab-paclitaxel<br>* specified does on specified days<br>* Other names: Abraxane;Drug: Onivyde<br>* specified dose on specified days<br>* Other names: irinotecan liposome;Drug: Fluorouracil<br>* specified dose on specified days<br>* Other names: 5-Fluorouracil;Drug: Gemcitabine<br>* specified dose on specified days<br>Drug: Leucovorin<br>* Specified dose on specified days<br>Drug: Irinotecan Hydrochloride<br>* Specified dose on specified days<br>|
| Experimental: Arm B<br>Cabiralizumab Q2W + Nivolumab Q4W | Biological: Cabiralizumab<br>* specified dose on specified days<br>* Other names: BMS-986227, FPA008;Biological: Nivolumab<br>* specified dose on specified days<br>* Other names: Opdivo, BMS-936558;|
| Experimental: Arm C<br>Cabiralizumab Q2W + Nivolumab Q4W and Gemcitabine + Nab-Paclitaxel (Abraxane®) D1, 8 and 15 Q4W | Biological: Cabiralizumab<br>* specified dose on specified days<br>* Other names: BMS-986227, FPA008;Drug: Nab-paclitaxel<br>* specified does on specified days<br>* Other names: Abraxane;Biological: Nivolumab<br>* specified dose on specified days<br>* Other names: Opdivo, BMS-936558;Drug: Gemcitabine<br>* specified dose on specified days<br>|
| Experimental: Arm D<br>Cabiralizumab Q2W + Nivolumab Q4W and Oxaliplatin/5-Flurouracil/Leucovorin (FOLFOX) Q2W | Biological: Cabiralizumab<br>* specified dose on specified days<br>* Other names: BMS-986227, FPA008;Biological: Nivolumab<br>* specified dose on specified days<br>* Other names: Opdivo, BMS-936558;Drug: Fluorouracil<br>* specified dose on specified days<br>* Other names: 5-Fluorouracil;Drug: Oxaliplatin<br>* specified dose on specified day<br>Drug: Leucovorin<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival (PFS) by Blinded Independent Central Review (BICR) |  | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival (PFS) by Investigator Assessment |  | Up to 12 months | 
| Progression Free Survival Rate (PFSR) |  | Up to 12 months | 
| Objective response rate (ORR) |  | Up to 12 Months | 
| Duration of response (DOR) |  | Up to 12 Months | 
| Overall Survival (OS) |  | Up to 2 Years | 
| Overall survival rate (OSR) |  | Up to 2 years | 
| Incidence of Adverse Events (AE) |  | Approximately 2 years | 
| Incidence of Serious Adverse Events (SAE) |  | Approximately 2 years | 
| Incidence of Adverse Events (AE) leading to discontinuation |  | Approximately 2 years | 
| Incidence of death |  | Approximately 2 years | 
| Number of clinically significant changes in lab assessment: Blood |  | Approximately 2 years | 
| Number of clinically significant changes in lab assessment: Blood Serum |  | Approximately 2 years | 
| Number of clinically significant changes in lab assessment: Urine |  | Approximately 2 years |