Clinical Trials /

Nivolumab + Cabiralizumab + Gemcitabine in Patients With Stage IV Pancreatic Cancer Achieving Disease Control in Response to First-line Chemotherapy (GemCaN Trial).

NCT03697564

Description:

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

Related Conditions:
  • Pancreatic Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Nivolumab + Cabiralizumab + Gemcitabine in Patients With Stage IV Pancreatic Cancer Achieving Disease Control in Response to First-line Chemotherapy (GemCaN Trial).
  • 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).

Clinical Trial IDs

  • ORG STUDY ID: 181395
  • NCT ID: NCT03697564

Conditions

  • Pancreatic Cancer Stage IV

Interventions

DrugSynonymsArms
Gemcitabinegemcitabine +nivolumab + cabiralizumab
Nivolumab 10 MG/ML Intravenous Solution [OPDIVO]Opdivogemcitabine +nivolumab + cabiralizumab
Cabiralizumabgemcitabine +nivolumab + cabiralizumab

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
gemcitabine +nivolumab + cabiralizumabExperimental
  • Gemcitabine
  • Nivolumab 10 MG/ML Intravenous Solution [OPDIVO]
  • Cabiralizumab

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression Free Survival (PFS)
Time Frame:6 months
Safety Issue:
Description:To estimate Progression Free Survival (PFS rates) at 6 months by RECIST1.1

Secondary Outcome Measures

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

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Hitendra Patel

Trial Keywords

  • Pancreating Cancer
  • Cancer
  • Stage IV
  • gemcitabine
  • nivolumab
  • cabiralizumab
  • BMS-986227
  • FPA008
  • GemCaN
  • Stand Up to Cancer

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