Try our beta test site
Trial record 1 of 1 for:    NCT02526017
Previous Study | Return to List | Next Study

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by Five Prime Therapeutics, Inc.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Five Prime Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT02526017
First received: August 13, 2015
Last updated: February 13, 2017
Last verified: February 2017
  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.

Condition Intervention Phase
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
Biological: BMS-936558
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase 1a/1b Study of FPA008 in Combination With Nivolumab in Patients With Selected Advanced Cancers

Resource links provided by NLM:


Further study details as provided by Five Prime Therapeutics, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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 ]

Estimated Enrollment: 280
Study Start Date: September 2015
Estimated Study Completion Date: August 2019
Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Phase 1 a monotherapy dose escalation
FPA-008: specified dose on specified days
Biological: FPA008
Other Name: anti-CSF-1R (Anti-colony stimulating factor-1 receptor)
Experimental: Phase 1a combination therapy dose escalation
FPA-008 + BMS-936558: specified dose on specified days
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 1b combination therapy dose expansion
FPA-008 + BMS-936558: specified dose on specified days
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02526017

Contacts
Contact: Medical Lead FPA008003@fiveprime.com

  Show 34 Study Locations
Sponsors and Collaborators
Five Prime Therapeutics, Inc.
Bristol-Myers Squibb
Investigators
Study Director: Medical Lead Five Prime Therapeutics, Inc.
  More Information

Responsible Party: Five Prime Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02526017     History of Changes
Other Study ID Numbers: FPA008-003 
Study First Received: August 13, 2015
Last Updated: February 13, 2017

Additional relevant MeSH terms:
Pancreatic Neoplasms
Head and Neck Neoplasms
Carcinoma, Renal Cell
Glioma
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Diseases
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nivolumab
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 20, 2017