Nivolumab + Cabiralizumab + Gemcitabine Versus Gemcitabine in Patients With Stage IV Pancreatic Cancer Achieving Disease Control in Response to First-line Chemotherapy (GemCaN Trial).
Sponsor:
Hitendra Patel
Collaborators:
Information provided by (Responsible Party):
Hitendra Patel，University of California, San Diego
| Tracking Information | |||
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| First Submitted Date ICMJE | September 28, 2018 | ||
| First Posted Date ICMJE | October 5, 2018 | ||
| Last Update Posted Date | October 5, 2018 | ||
| Actual Study Start Date ICMJE | October 2018 | ||
| Estimated Primary Completion Date | October 2020 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
Progression Free Survival (PFS)[ Time Frame: 6 months ] To estimate Progression Free Survival (PFS rates) at 6 months by RECIST1.1 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||
| Current Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||
| Brief Title ICMJE | Nivolumab + Cabiralizumab + Gemcitabine Versus Gemcitabine in Patients With Stage IV Pancreatic Cancer Achieving Disease Control in Response to First-line Chemotherapy (GemCaN Trial). |
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| Official Title ICMJE | 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). |
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| Brief Summary | 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 |
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| Detailed Description | |||
| Study Type ICMJE | Interventional | ||
| Study Phase | Phase 4 | ||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Masking: Interventional Masking Description: Primary Purpose: Treatment |
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| Condition ICMJE | |||
| Intervention ICMJE |
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| Study Arms |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Not yet recruiting | ||
| Estimated Enrollment ICMJE |
40 | ||
| Original Estimated Enrollment ICMJE | Same as current | ||
| Estimated Study Completion Date | October 2020 | ||
| Estimated Primary Completion Date | October 2020 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | 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. | ||
| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers | No | ||
| Listed Location Countries ICMJE | United States | ||
| Removed Location Countries | |||
| Administrative Information | Has Data Monitoring Committee | ||
| U.S. FDA-regulated Product |
Studies a U.S. FDA-regulated Drug Product: Yes Studies a U.S. FDA-regulated Device Product: No |
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| IPD Sharing Statement |
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| Responsible Party | Hitendra Patel，University of California, San Diego | ||
| Study Sponsor ICMJE | Hitendra Patel | ||
| Collaborators ICMJE | |||
| Investigators ICMJE |
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| PRS Account | University of California, San Diego | ||
| Verification Date | October 2018 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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