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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
Sponsor:
Collaborator:
Stand Up To Cancer
Information provided by (Responsible Party):
Hitendra Patel, University of California, San Diego

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


Condition or disease Intervention/treatment Phase
Pancreatic Cancer Stage IV Drug: Gemcitabine Drug: Nivolumab 10 MG/ML Intravenous Solution [OPDIVO] Drug: Cabiralizumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: gemcitabine +nivolumab + cabiralizumab Drug: Gemcitabine
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

Drug: Cabiralizumab
4mg/kg IV on day 1 and 15 Q4W




Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: 6 months ]
    To estimate Progression Free Survival (PFS rates) at 6 months by RECIST1.1


Secondary Outcome Measures :
  1. Incidence of Treatment-Emergent Grade 2-5 Adverse Events assessed using NCI CTCAE v5.0 toxicity criteria [ Time Frame: 6 months ]
  2. Overall Survival (OS) [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Hitendra Patel, MD 858-822-3115 hip003@ucsd.edu
Contact: Brittney Lehmann bnlehmann@ucsd.edu

Locations
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United States, California
UCSD Moores Cancer Center
La Jolla, California, United States, 92093
Sponsors and Collaborators
Hitendra Patel
Stand Up To Cancer
Investigators
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Principal Investigator: Hitendra Patel, MD University of California, San Diego
Principal Investigator: Andrew Lowy, MD University of California, San Diego

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Responsible Party: Hitendra Patel, Associate Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03697564     History of Changes
Other Study ID Numbers: 181395
First Posted: October 5, 2018    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hitendra Patel, University of California, San Diego:
Pancreating Cancer
Cancer
Stage IV
gemcitabine
nivolumab
cabiralizumab
BMS-986227
FPA008
GemCaN
Stand Up to Cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Nivolumab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological