Pancreatic Cancer Research

Clinical trialPhase 2Completed

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

Open Label Randomized Phase II Trial of Nivolumab + Cabiralizumab (BMS-986227, FPA008) + Gemcitabine in Patients With Stage IV Pancreatic Cancer Achieving Disease Control in Response to First-line Chemotherapy (GemCaN Trial)

Outcome
Outcome unknown
Phase
Phase 2
Status
Completed
Study type
Interventional
Start
31 October 2019
Expected end
13 July 2023
Enrollment
2 participants
Sites
1
Primary outcomes
Number of Participants With Progression Free Survival (PFS)
Sponsor
Other
Results posted
2025-08-06
Last update
6 August 2025

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Brief summary public domain (ClinicalTrials.gov)

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.

Detailed description public domain (ClinicalTrials.gov)

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

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Number of Participants With Progression Free Survival (PFS) [6 months]. Number, participants. Gemcitabine +Nivolumab + Cabiralizumab (n=2): 1.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Number of Participants With Overall Survival (OS) [6 months]. Number, participants. Gemcitabine +Nivolumab + Cabiralizumab (n=2): 1.