Clinical Trials /

Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers

NCT02526017

Description:

This is a phase 1a/b single-arm, open-label study to evaluate safety, tolerability, PK, and clinical benefit of Cabiralizumab in combination with nivolumab in patients with selected advanced cancers.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Active, not recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study of FPA008 in Combination With Nivolumab in Patients With Selected Advanced Cancers
  • Official Title: A Phase 1a/1b Study of FPA008 in Combination With Nivolumab in Patients With Selected Advanced Cancers

Clinical Trial IDs

  • ORG STUDY ID: FPA008-003
  • NCT ID: NCT02526017

Conditions

  • Advanced Solid Tumors, Including But Not Limited to Lung Cancer
  • Head and Neck Cancer
  • Pancreatic Cancer
  • Ovarian Cancer
  • Renal Cell Carcinoma
  • Malignant Glioma

Interventions

DrugSynonymsArms
FPA008anti-CSF-1R (Anti-colony stimulating factor-1 receptor)Phase 1 a monotherapy dose escalation
BMS-936558anti-PD-1 (anti-programmed-death-1), MDX-1106, NivolumabPhase 1a combination therapy dose escalation

Purpose

This is a phase 1a/b single-arm, open-label study to evaluate safety, tolerability, PK, and clinical benefit of FPA008 in combination with nivolumab in patients with selected advanced cancers.

Trial Arms

NameTypeDescriptionInterventions
Phase 1 a monotherapy dose escalationExperimentalFPA-008: specified dose on specified days
    Phase 1a combination therapy dose escalationExperimentalFPA-008 + BMS-936558: specified dose on specified days
      Phase 1b combination therapy dose expansionExperimentalFPA-008 + BMS-936558: specified dose on specified days

        Eligibility Criteria

                Inclusion Criteria:
        
                  -  Patients must have at least one measurable lesion at baseline by computed tomography
                     (CT) or magnetic resonance imaging (MRI) as per RECIST v1.1 criteria.
        
                  -  Patients must have had progressive disease on, after, or refused, appropriate approved
                     therapy for their tumor type.
        
                  -  Understand and sign an IRB/IEC-approved ICF prior to any study-specific evaluation
        
                  -  ECOG performance status of 0 or 1
        
                  -  Willing and able to comply with all study procedures
        
                Exclusion Criteria:
        
                  -  Current or history of clinically significant muscle disorders (e.g., myositis), recent
                     unresolved muscle injury, or any condition known to elevate serum CK levels
        
                  -  Decreased cardiac function with NYHA > Class 2
        
                  -  Uncontrolled or significant heart disorder such as unstable angina
        
                  -  Significant abnormalities on ECG at screening. QTcF >450 msec for males or >470 msec
                     for females at screening
        
                  -  History of anti-drug antibodies, severe allergic, anaphylactic, or other
                     infusion-related reaction to a previous biologic agent
        
                  -  Positive test for latent tuberculosis (TB) at screening (Quantiferon test) or evidence
                     of active TB
        
                  -  Patients with abnormal serum chemistry values, which in the opinion of the
                     Investigator is considered to be clinically significant, will be excluded from the
                     study
        
                  -  Lack of peripheral venous or central venous access or any condition that would
                     interfere with drug administration or collection of study samples
        
                  -  Any uncontrolled medical condition or psychiatric disorder which, in the opinion of
                     the Investigator, would pose a risk to patient safety or interfere with study
                     participation or interpretation of individual patient results
        
                  -  Pregnant or breastfeeding
        
                  -  Current unresolved infection or history of chronic, active, clinically significant
                     infection (viral, bacterial, fungal, or other) which, in the opinion of the
                     Investigator, would preclude the patient from exposure to a biologic agent or pose a
                     risk to patient safety
        
                  -  Prior exposure to any CSF1R pathway inhibitors
              
        Maximum Eligible Age:N/A
        Minimum Eligible Age:18 Years
        Eligible Gender:All
        Healthy Volunteers:No

        Primary Outcome Measures

        Measure:Safety: Incidence of Grade 3 and Grade 4 Adverse Events (AEs) and clinical laboratory abnormalities defined as Dose Limiting Toxicities (Phase 1a)
        Time Frame:20 weeks
        Safety Issue:
        Description:

        Secondary Outcome Measures

        Measure:Efficacy: Overall survival (OS) including median OS and one-year OS, duration of response (DOR), and progression free survival (PFS) (Phase 1b)
        Time Frame:52 weeks
        Safety Issue:
        Description:
        Measure:PK parameters of FPA008 : Area under the curve (AUC), clearance (CL), maximum observed concentration (Cmax), minimum observed concentration (Cmin), and volume of distribution at steady state (Vss). (Phase 1a and 1b)
        Time Frame:52 weeks
        Safety Issue:
        Description:
        Measure:Immunogenicity of FPA008: Analysis of anti-FPA008 antibody level in serum (Phase 1a and 1b)
        Time Frame:52 weeks
        Safety Issue:
        Description:
        Measure:Immunogenicity of nivolumab: Analysis of anti-nivolumab antibody level in serum (Phase 1a and 1b)
        Time Frame:52 weeks
        Safety Issue:
        Description:
        Measure:PD biomarkers: Changes in macrophage and T-cell levels based on expression of CD68 and CD8 in tumor biopsy samples, changes in cytokine levels by multiplex analysis, and changes in whole blood monocyte subsets (Phase 1a and 1b)
        Time Frame:52 weeks
        Safety Issue:
        Description:

        Details

        Phase:Phase 1
        Primary Purpose:Interventional
        Overall Status:Recruiting
        Lead Sponsor:Five Prime Therapeutics, Inc.

        Last Updated

        March 13, 2017