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.
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
| Drug | Synonyms | Arms |
|---|
| Cabiralizumab | BMS-986227, FPA008 | Arm B |
| Nab-paclitaxel | Abraxane | Arm A |
| Onivyde | irinotecan liposome | Arm A |
| Nivolumab | Opdivo, BMS-936558 | Arm B |
| Fluorouracil | 5-Fluorouracil | Arm A |
| Gemcitabine | | Arm A |
| Oxaliplatin | | Arm D |
| Leucovorin | | Arm A |
| Irinotecan Hydrochloride | | Arm 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
| Name | Type | Description | Interventions |
|---|
| Arm A | Active Comparator | Investigator choice of chemotherapy:
Gemcitabine/Nab-Paclitaxel (Abraxane®) or 5-Fluorouracil/Leucovorin/Irinotecan Liposome (ONIVYDE) | - Nab-paclitaxel
- Onivyde
- Fluorouracil
- Gemcitabine
- Leucovorin
- Irinotecan Hydrochloride
|
| Arm B | Experimental | Cabiralizumab Q2W + Nivolumab Q4W | |
| Arm C | Experimental | Cabiralizumab Q2W + Nivolumab Q4W and Gemcitabine + Nab-Paclitaxel (Abraxane®) D1, 8 and 15 Q4W | - Cabiralizumab
- Nab-paclitaxel
- Nivolumab
- Gemcitabine
|
| Arm D | Experimental | Cabiralizumab Q2W + Nivolumab Q4W and Oxaliplatin/5-Flurouracil/Leucovorin (FOLFOX) Q2W | - 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: | Progression free survival (PFS) by Blinded Independent Central Review (BICR) |
| Time Frame: | Up to 12 months |
| Safety Issue: | |
| Description: | |
Secondary Outcome Measures
| Measure: | Progression Free Survival (PFS) by Investigator Assessment |
| Time Frame: | Up to 12 months |
| Safety Issue: | |
| Description: | |
| Measure: | Progression Free Survival Rate (PFSR) |
| Time Frame: | Up to 12 months |
| Safety Issue: | |
| Description: | |
| Measure: | Objective response rate (ORR) |
| Time Frame: | Up to 12 Months |
| Safety Issue: | |
| Description: | |
| Measure: | Duration of response (DOR) |
| Time Frame: | Up to 12 Months |
| Safety Issue: | |
| Description: | |
| Measure: | Overall Survival (OS) |
| Time Frame: | Up to 2 Years |
| Safety Issue: | |
| Description: | |
| Measure: | Overall survival rate (OSR) |
| Time Frame: | Up to 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 Adverse Events (AE) leading to discontinuation |
| Time Frame: | Approximately 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Incidence of death |
| Time Frame: | Approximately 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Number of clinically significant changes in lab assessment: Blood |
| Time Frame: | Approximately 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Number of clinically significant changes in lab assessment: Blood Serum |
| Time Frame: | Approximately 2 years |
| Safety Issue: | |
| Description: | |
| Measure: | Number of clinically significant changes in lab assessment: Urine |
| Time Frame: | Approximately 2 years |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | Bristol-Myers Squibb |
Last Updated
September 10, 2020
