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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

Tracking Information
First Submitted Date  ICMJE September 28, 2018
First Posted Date  ICMJE October 5, 2018
Last Update Posted Date May 6, 2019
Estimated Study Start Date  ICMJE September 2019
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2018)
Progression Free Survival (PFS) [ Time Frame: 6 months ]
To estimate Progression Free Survival (PFS rates) at 6 months by RECIST1.1
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03697564 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2018)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nivolumab + Cabiralizumab + Gemcitabine in Patients With Stage IV Pancreatic Cancer Achieving Disease Control in Response to First-line Chemotherapy (GemCaN Trial).
Official Title  ICMJE 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).
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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Cancer Stage IV
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: gemcitabine +nivolumab + cabiralizumab
Interventions:
  • Drug: Gemcitabine
  • Drug: Nivolumab 10 MG/ML Intravenous Solution [OPDIVO]
  • Drug: Cabiralizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: October 3, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hitendra Patel, MD 858-822-3115 hip003@ucsd.edu
Contact: Brittney Lehmann bnlehmann@ucsd.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03697564
Other Study ID Numbers  ICMJE 181395
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hitendra Patel, University of California, San Diego
Study Sponsor  ICMJE Hitendra Patel
Collaborators  ICMJE Stand Up To Cancer
Investigators  ICMJE
Principal Investigator: Hitendra Patel, MD University of California, San Diego
Principal Investigator: Andrew Lowy, MD University of California, San Diego
PRS Account University of California, San Diego
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP