Nivolumab + Cabiralizumab + Gemcitabine in Patients With Stage IV Pancreatic Cancer Achieving Disease Control in Response to First-line Chemotherapy (GemCaN Trial).
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|ClinicalTrials.gov Identifier: NCT03697564|
Recruitment Status : Not yet recruiting
First Posted : October 5, 2018
Last Update Posted : May 6, 2019
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
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer Stage IV||Drug: Gemcitabine Drug: Nivolumab 10 MG/ML Intravenous Solution [OPDIVO] Drug: Cabiralizumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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).|
|Estimated Study Start Date :||September 2019|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
|Experimental: gemcitabine +nivolumab + cabiralizumab||
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
Other Name: Opdivo
4mg/kg IV on day 1 and 15 Q4W
- Progression Free Survival (PFS) [ Time Frame: 6 months ]To estimate Progression Free Survival (PFS rates) at 6 months by RECIST1.1
- Incidence of Treatment-Emergent Grade 2-5 Adverse Events assessed using NCI CTCAE v5.0 toxicity criteria [ Time Frame: 6 months ]
- Overall Survival (OS) [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03697564
|Contact: Hitendra Patel, MDfirstname.lastname@example.org|
|Contact: Brittney Lehmannemail@example.com|
|United States, California|
|UCSD Moores Cancer Center|
|La Jolla, California, United States, 92093|
|Principal Investigator:||Hitendra Patel, MD||University of California, San Diego|
|Principal Investigator:||Andrew Lowy, MD||University of California, San Diego|