Nivolumab + Cabiralizumab + Gemcitabine Versus Gemcitabine in Patients With Stage IV Pancreatic Cancer Achieving Disease Control in Response to First-line Chemotherapy (GemCaN Trial).
| Status: | Not yet recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/11/2019 |
| Start Date: | July 2019 |
| End Date: | December 2021 |
| Contact: | Hitendra Patel, MD |
| Email: | hip003@ucsd.edu |
| Phone: | 858-822-3115 |
Open Label Randomized Phase II Trial of Nivolumab + Cabiralizumab (BMS-986227, FPA008) + Gemcitabine Versus Gemcitabine in Patients With Stage IV Pancreatic Cancer Achieving Disease Control in Response to First-line Chemotherapy (GemCaN Trial).
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
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
Inclusion Criteria:
- 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.
Measurable disease by RECIST 1.1.
Demonstrate adequate organ function
Normal Vitamin D level.
Able to submit an archival tumor specimen (primary or metastatic site). Patients with
cytology only that do not have adequate archived tumor specimen available, will require a
baseline biopsy.
Exclusion Criteria:
- 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.
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