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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.
  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: None (Open Label)
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
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): NCT02526017


Contacts
Contact: Medical Lead FPA008003@fiveprime.com

  Hide Study Locations
Locations
United States, Arizona
Scottsdale Healthcare Hospitals DBA Honor Health Recruiting
Scottsdale, Arizona, United States, 85258
Principal Investigator: Michael S Gordon, MD         
United States, California
Moores UC San Diego Cancer Center Recruiting
La Jolla, California, United States, 92093
Principal Investigator: Sandip Patel, MD         
Norris Comprehensive Cancer Center, University of Southern California Recruiting
Los Angeles, California, United States, 90033
Principal Investigator: Anthony El-Khoueiry, MD         
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90048
Principal Investigator: Surasak Phuphanich, MD         
UC Davis Comprehensive Cancer Center Recruiting
Sacramento, California, United States, 95817
Principal Investigator: Karen Kelly, MD         
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Principal Investigator: Nicholas A Butowski, MD         
Sarcoma Oncology Research Center Recruiting
Santa Monica, California, United States, 90403
Principal Investigator: Kamalesh K. Sankhala, MD         
UCLA Hematology/Oncology- Santa Monica Recruiting
Santa Monica, California, United States, 90404
Principal Investigator: Zev A. Wainberg, MD         
United States, Florida
Mount Sinai Comprehensive Cancer Center Recruiting
Miami Beach, Florida, United States, 33140
Principal Investigator: Jose Lutzsky, MD         
H. Lee Moffitt Cancer Center and Research Institute Recruiting
Tampa, Florida, United States, 33612
Principal Investigator: Heloisa Soares, MD,PhD         
United States, Georgia
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Principal Investigator: Bassel El-Rayes, MD         
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Principal Investigator: Nicklas Pfanzelter, MD         
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Principal Investigator: Jason J Luke, MD         
United States, Indiana
Indiana University Health Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Principal Investigator: Bert H. O'Neil, MD         
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Principal Investigator: Mohammed Milhem, MD         
United States, Kentucky
Norton Cancer Institute, Norton Healthcare Pavilion Recruiting
Louisville, Kentucky, United States, 40202
Principal Investigator: John T. Hamm, MD         
United States, Maryland
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center Recruiting
Baltimore, Maryland, United States, 21287
Principal Investigator: Julie Brahmer, MD         
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Principal Investigator: Frank S. Hodi, MD         
United States, Michigan
Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Principal Investigator: Shirish Gadgeel, MD         
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Principal Investigator: Ding Wang, MD, PhD         
United States, Minnesota
Allina Health, Virginia Piper Cancer Institute Recruiting
Minneapolis, Minnesota, United States, 55407
Principal Investigator: Michaela L. Tsai, MD         
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Principal Investigator: Mateusz Opyrchal, MD, PhD         
Memorial Sloan Kettering Recruiting
New York, New York, United States, 10065
Principal Investigator: Mariza Daras, MD         
United States, Ohio
The Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Principal Investigator: Philip D. Leming, MD         
United States, Oregon
Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213
Principal Investigator: Rachel Sanborn, MD         
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Principal Investigator: Matthew Taylor, MD         
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Principal Investigator: Peter O'Dwyer, MD         
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Principal Investigator: Jennifer Johnson, MD         
University of Pittsburgh Cancer Institute, William M. Cooper Ambulatory Pavilion of the Hillman Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Principal Investigator: James J. Lee, MD, PhD         
United States, South Carolina
Hollings Cancer Center, Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Principal Investigator: Carolyn Britten, MD         
United States, Tennessee
Henry-Joyce Cancer Clinic, Vanderbilt-Ingram Cancer Center, Recruiting
Nashville, Tennessee, United States, 37232
Principal Investigator: Emily Chan, MD         
United States, Texas
Baylor Charles A. Sammons Cancer Center, Baylor University Medical Center Recruiting
Dallas, Texas, United States, 75246
Principal Investigator: Karen Fink, MD, PhD         
University of Texas Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Principal Investigator: Muhammad S Beg, MD         
Mischer Neuroscience Associates, The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Jay-Jiguang Zhu, MD         
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Sarina A. Piha-Paul, MD         
Cancer Therapy & Research Center, University of Texas Health Science Center at San Antonio Recruiting
San Antonio, Texas, United States, 78229
Principal Investigator: Andrew Brenner, MD         
South Texas Accelerated Research Therapeutics, LLC Recruiting
San Antonio, Texas, United States, 78229
Principal Investigator: Drew W Rasco, MD         
United States, Utah
Huntsman Cancer Institute Recruiting
Salt Lake City, Utah, United States, 84112
Principal Investigator: Sunil Sharma, MD         
United States, Washington
Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109
Principal Investigator: John Thompson, MD         
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
First Submitted: August 13, 2015
First Posted: August 18, 2015
Last Update Posted: March 15, 2017
Last Verified: March 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