Nivolumab + Cabiralizumab + Gemcitabine In Patients With Stage IV Pancreatic Cancer

Study Overview

Nivolumab + Cabiralizumab + Gemcitabine in Patients With Stage IV Pancreatic Cancer

The purpose of this study is to see if the combination of nivolumab + cabiralizumab + gemcitabine can give prolonged disease control in patients with advanced pancreatic cancer compared to gemcitabine alone. Cabiralizumab is an antibody (a type of protein) that binds to a molecule called CSF-1r. CSF-1r is a molecule present on different types of cells in your immune system that controls parts of your immune system. Blocking CSF-lr could potentially stop the cancer cells which it appears on from escaping the immune system, which could then act to kill the cancer cells. Nivolumab is an anti-PD-1 antibody that boost the body's immune system. It works by attaching to and blocking a molecule on white blood cells called PD-1. PD-1 is a protein that is present on different types of cells in your immune system and controls parts of your immune system by shutting it down. Antibodies that block PD-1 can potentially prevent PD-1 from shutting down the immune system, thus allowing immune cells to recognize and destroy cancer cells. Gemcitabine is currently used to treat advanced or metastasized (spread) pancreatic cancer. It is used in patients whose disease cannot be removed by surgery and who have already been treated with other chemotherapy

Pancreatic Cancer Stage IV

DRUG: Gemcitabine
DRUG: Nivolumab 10 MG/ML Intravenous Solution [OPDIVO]
DRUG: Cabiralizumab

181395

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2018-09-28	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-02-03
First Submitted that Met QC Criteria 2018-10-03	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-02-06
First Posted (ACTUAL) 2018-10-05	Results First Posted N/A	Last Verified 2025-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: gemcitabine +nivolumab + cabiralizumab gemcitabine +nivolumab + cabiralizumab	DRUG: Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 Q4W DRUG: Nivolumab 10 MG/ML Intravenous Solution [OPDIVO] 480mg IV on Day 1 Q4W DRUG: Cabiralizumab 4mg/kg IV on day 1 and 15 Q4W

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: gemcitabine +nivolumab + cabiralizumab

gemcitabine +nivolumab + cabiralizumab

DRUG: Gemcitabine

1000 mg/m2 IV on days 1, 8, and 15 Q4W

DRUG: Nivolumab 10 MG/ML Intravenous Solution [OPDIVO]

480mg IV on Day 1 Q4W

DRUG: Cabiralizumab

4mg/kg IV on day 1 and 15 Q4W

Primary Outcome Measures	Measure Description	Time Frame
Progression Free Survival (PFS)	To estimate Progression Free Survival (PFS rates) at 6 months by RECIST1.1	6 months

Secondary Outcome Measures	Measure Description	Time Frame
Incidence of Treatment-Emergent Grade 2-5 Adverse Events assessed using NCI CTCAE v5.0 toxicity criteria	Incidence of Treatment-Emergent Grade 2-5 Adverse Events assessed using NCI CTCAE v5.0 toxicity criteria	6 months
Overall Survival (OS)	Overall Survival (OS)	6 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histologically or cytologically confirmed pancreatic adenocarcinoma with metastasis
Must be off their prior cytotoxic regimen a minimum of two weeks but no more than four weeks from initiating trial treatment.

Is currently participating and receiving trial therapy or has participated in a trial of an investigational agent and received trial therapy or used an investigational device within 3 weeks of the first dose of trial treatment.
Hypersensitivity to cabiralizumab, nivolumab, or gemcitabine or any of its excipients.
Previous malignancies (except non-melanoma skin cancers, and in situ bladder, gastric, colorectal, endometrial, cervical/dysplasia, melanoma, or breast cancers) unless complete remission was achieved at least 2 years prior to study entry and no additional therapy is required during the study period.
Evidence of central nervous system (CNS) metastasis
Participants with active, known, or suspected autoimmune disease.
Current or history of clinically significant muscle disorders (e.g., myositis), recent unresolved muscle injury, or any condition known to elevate serum CK levels.
Uncontrolled or significant cardiovascular disease
Prior organ allograft or allogeneic bone marrow transplantation.
Any uncontrolled inflammatory GI disease including Crohn's Disease and ulcerative colitis.
Evidence of coagulopathy or bleeding diathesis.
Has received prior therapy with a CSF-1R pathway inhibitors, anti-PD-1, anti-PD-L1, anti PD-L2, anti-CTLA-4.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Stand Up To Cancer
Lustgarten Foundation

Investigators

PRINCIPAL_INVESTIGATOR: Hitendra Patel, MD, University of California, San Diego

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record