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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Advanced Pancreatic Cancer

Treatments: Drug: Onivyde; Drug: Nab-paclitaxel; Biological: Cabiralizumab; Drug: Fluorouracil; Drug: Leucovorin; Drug: Oxaliplatin; Drug: Gemcitabine; Drug: Irinotecan Hydrochloride; Biological: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03336216

CA025-006

Details and patient eligibility

About

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.

Enrollment: 205 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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205 participants in 4 patient groups

Arm A

Active Comparator group

Description:

Investigator choice of chemotherapy: Gemcitabine/Nab-Paclitaxel (Abraxane®) or 5-Fluorouracil/Leucovorin/Irinotecan Liposome (ONIVYDE)

Treatment:

Drug: Irinotecan Hydrochloride

Drug: Gemcitabine

Drug: Leucovorin

Drug: Fluorouracil

Drug: Nab-paclitaxel

Drug: Onivyde

Arm B

Experimental group

Description:

Cabiralizumab Q2W + Nivolumab Q4W

Treatment:

Biological: Nivolumab

Biological: Cabiralizumab

Arm C

Experimental group

Description:

Cabiralizumab Q2W + Nivolumab Q4W and Gemcitabine + Nab-Paclitaxel (Abraxane®) D1, 8 and 15 Q4W

Treatment:

Biological: Nivolumab

Drug: Gemcitabine

Biological: Cabiralizumab

Drug: Nab-paclitaxel

Arm D

Experimental group

Description:

Cabiralizumab Q2W + Nivolumab Q4W and Oxaliplatin/5-Flurouracil/Leucovorin (FOLFOX) Q2W

Treatment:

Biological: Nivolumab

Drug: Leucovorin

Drug: Oxaliplatin

Drug: Fluorouracil

Biological: Cabiralizumab