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Study of FPA008 in Combination With Nivolumab in Patients With Selected Advanced Cancers (FPA008-003)

This study is currently recruiting participants.
Verified March 2017 by Five Prime Therapeutics, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02526017
First Posted: August 18, 2015
Last Update Posted: March 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Five Prime Therapeutics, Inc.
August 13, 2015
August 18, 2015
March 15, 2017
September 2015
May 2019   (Final data collection date for primary outcome 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 ]
  • Recommended dose (RD) of FPA008 with nivolumab (Phase 1a) [ Time Frame: 20 weeks ]
  • Safety: Incidence of AEs, Serious AEs (SAEs), clinical laboratory abnormalities, and ECG abnormalities (Phase 1a and 1b) [ Time Frame: 52 weeks ]
  • Safety: Incidence of treatment discontinuations, modifications, and interruptions due to adverse events (Phase 1b) [ Time Frame: 52 weeks ]
  • Efficacy: Objective response rate (ORR) defined as the total number of patients with confirmed responses of either complete response (CR) or partial response (PR) divided by the total number of patients evaluable for a response (Phase 1b) [ Time Frame: 52 weeks ]
Same as current
Complete list of historical versions of study NCT02526017 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
  • Immunogenicity of FPA008: Analysis of anti-FPA008 antibody level in serum (Phase 1a and 1b) [ Time Frame: 52 weeks ]
  • Immunogenicity of nivolumab: Analysis of anti-nivolumab antibody level in serum (Phase 1a and 1b) [ Time Frame: 52 weeks ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Immunogenicity of FPA008: Analysis of anti-FPA008 antibody level in serum (Phase 1a and 1b) [ Time Frame: 52 weeks ]
  • Immunogenicity of nivolumab: Analysis of anti-nivolumab antibody level in serum (Phase 1a and 1b) [ Time Frame: 52 weeks ]
  • PD biomarkers: Changes in macrophage and T-cell levels based on expression of CD8 and CD68 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 ]
PD biomarkers: Changes in gene expression in whole blood or peripheral blood mononuclear cells, peripheral T-cell and other leukocyte phenotypes, and levels of peripheral myeloid-derived suppressor cells (Phase 1a and 1b) [ Time Frame: 52 weeks ]
Same as current
 
Study of FPA008 in Combination With Nivolumab in Patients With Selected Advanced Cancers
A Phase 1a/1b Study of FPA008 in Combination With Nivolumab in Patients With Selected Advanced Cancers
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Advanced Solid Tumors, Including But Not Limited to Lung Cancer
  • Head and Neck Cancer
  • Pancreatic Cancer
  • Ovarian Cancer
  • Renal Cell Carcinoma
  • Malignant Glioma
  • Biological: FPA008
    Other Name: anti-CSF-1R (Anti-colony stimulating factor-1 receptor)
  • Biological: BMS-936558
    Other Names:
    • anti-PD-1 (anti-programmed-death-1)
    • MDX-1106
    • Nivolumab
  • Experimental: Phase 1 a monotherapy dose escalation
    FPA-008: specified dose on specified days
    Intervention: Biological: FPA008
  • Experimental: Phase 1a combination therapy dose escalation
    FPA-008 + BMS-936558: specified dose on specified days
    Interventions:
    • Biological: FPA008
    • Biological: BMS-936558
  • Experimental: Phase 1b combination therapy dose expansion
    FPA-008 + BMS-936558: specified dose on specified days
    Interventions:
    • Biological: FPA008
    • Biological: BMS-936558
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
280
August 2019
May 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Medical Lead FPA008003@fiveprime.com
United States
 
 
NCT02526017
FPA008-003
Yes
Not Provided
Not Provided
Five Prime Therapeutics, Inc.
Five Prime Therapeutics, Inc.
Bristol-Myers Squibb
Study Director: Medical Lead Five Prime Therapeutics, Inc.
Five Prime Therapeutics, Inc.
March 2017

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