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

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ClinicalTrials.gov Identifier: NCT02526017
Recruitment Status : Active, not recruiting
First Posted : August 18, 2015
Last Update Posted : October 1, 2018
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Five Prime Therapeutics, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment 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  (Clinical Trial)
Estimated Enrollment : 295 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1a/1b Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
Study Start Date : September 2015
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2020


Arm Intervention/treatment
Experimental: Phase 1 a monotherapy dose escalation
FPA008: specified dose on specified days
Biological: FPA008
Other Names:
  • anti-CSF-1R (Anti-colony stimulating factor-1 receptor)
  • Cabiralizumab

Experimental: Phase 1a combination therapy dose escalation
FPA008 + BMS-936558: specified dose on specified days
Biological: FPA008
Other Names:
  • anti-CSF-1R (Anti-colony stimulating factor-1 receptor)
  • Cabiralizumab

Biological: BMS-936558
Other Names:
  • anti-PD-1 (anti-programmed-death-1)
  • MDX-1106
  • Nivolumab

Experimental: Phase 1b combination therapy dose expansion
FPA008 + BMS-936558: specified dose on specified days
Biological: FPA008
Other Names:
  • anti-CSF-1R (Anti-colony stimulating factor-1 receptor)
  • Cabiralizumab

Biological: BMS-936558
Other Names:
  • anti-PD-1 (anti-programmed-death-1)
  • MDX-1106
  • Nivolumab




Primary Outcome Measures :
  1. 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 ]
  2. Recommended dose (RD) of cabiralizumab with nivolumab (Phase 1a) [ Time Frame: 20 weeks ]
  3. Safety: Incidence of AEs, Serious AEs (SAEs), clinical laboratory abnormalities, and ECG abnormalities (Phase 1a and 1b) [ Time Frame: 52 weeks ]
  4. Safety: Incidence of treatment discontinuations, modifications, and interruptions due to adverse events (Phase 1b) [ Time Frame: 52 weeks ]
  5. 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 :
  1. 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 ]
  2. PK parameters of cabiralizumab : 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 ]
  3. Immunogenicity of cabiralizumab: Analysis of anti-FPA008 antibody level in serum (Phase 1a and 1b) [ Time Frame: 52 weeks ]
  4. Immunogenicity of nivolumab: Analysis of anti-nivolumab antibody level in serum (Phase 1a and 1b) [ Time Frame: 52 weeks ]
  5. 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:
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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


  Hide Study Locations
Locations
United States, Arizona
Scottsdale Healthcare Hospitals DBA Honor Health
Scottsdale, Arizona, United States, 85258
United States, California
Moores UC San Diego Cancer Center
La Jolla, California, United States, 92093
Norris Comprehensive Cancer Center, University of Southern California
Los Angeles, California, United States, 90033
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Center
Los Angeles, California, United States, 90048
UC Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
University of California, San Francisco
San Francisco, California, United States, 94143
Sarcoma Oncology Research Center
Santa Monica, California, United States, 90403
UCLA Hematology/Oncology- Santa Monica
Santa Monica, California, United States, 90404
United States, Florida
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States, 33140
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
United States, Indiana
Indiana University Health Hospital
Indianapolis, Indiana, United States, 46202
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Kentucky
Norton Cancer Institute, Norton Healthcare Pavilion
Louisville, Kentucky, United States, 40202
United States, Maryland
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Minnesota
Allina Health, Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States, 55407
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Memorial Sloan Kettering
New York, New York, United States, 10065
United States, Ohio
The Christ Hospital
Cincinnati, Ohio, United States, 45219
United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
University of Pittsburgh Cancer Institute, William M. Cooper Ambulatory Pavilion of the Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Hollings Cancer Center, Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Henry-Joyce Cancer Clinic, Vanderbilt-Ingram Cancer Center,
Nashville, Tennessee, United States, 37232
United States, Texas
Baylor Charles A. Sammons Cancer Center, Baylor University Medical Center
Dallas, Texas, United States, 75246
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Mischer Neuroscience Associates, The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Cancer Therapy & Research Center, University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States, 78229
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
United States, Washington
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Five Prime Therapeutics, Inc.
Bristol-Myers Squibb
Investigators
Study Director: Medical Lead Five Prime Therapeutics, Inc.

Responsible Party: Five Prime Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02526017     History of Changes
Other Study ID Numbers: FPA008-003
First Posted: August 18, 2015    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: May 2018

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