Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
NCT ID: NCT02526017
Last Updated: 2022-03-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
313 participants
INTERVENTIONAL
2015-09-08
2019-11-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1a Monotherapy Dose Escalation
Cabiralizumab administered at 2 mg/kg every 2 weeks (Q2W), 4 mg/kg Q2W and 6 mg/kg Q2W in participants with any solid tumor.
Cabiralizumab
Solution for IV administration
Phase 1a Combination Therapy Dose Escalation
Nivolumab 3 mg/kg Q2W + cabiralizumab at the following doses: 1 mg/kg, 2 mg/kg, 4 mg/kg, and 6 mg/kg Q2W. Also nivolumab 3 mg/kg + cabiralizumab 4 mg/kg every 3 weeks (Q3W). Participants with any solid tumor.
Cabiralizumab
Solution for IV administration
Nivolumab
Solution for IV administration
Phase 1b Combination Therapy Dose Expansion
The expansion phase would use the recommended dose determined in Phase 1a: cabiralizumab 4 mg/kg + nivolumab 3 mg/kg Q2W. Participants are enrolled for the following advanced cancer types: non-small cell lung cancer (anti-programmed cell death 1 \[PD1\] targeted drug naïve), non-small cell lung cancer (prior treatment with anti-PD-1), pancreatic cancer, ovarian cancer, renal cell cancer, glioblastoma, and melanoma.
Cabiralizumab
Solution for IV administration
Nivolumab
Solution for IV administration
Interventions
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Cabiralizumab
Solution for IV administration
Nivolumab
Solution for IV administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must have had progressive disease on, after, or refused, appropriate approved therapy for their tumor type.
* Patients must have histologically or cytologically confirmed solid tumor that is locally recurrent or metastatic and has progressed following standard treatment or is not appropriate for standard treatment
* Understand and sign an Institutional review board/Independent ethics committee (IRB/IEC)-approved informed consent form (ICF) prior to any study-specific evaluation
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Willing and able to comply with all study procedures
Exclusion Criteria
* Decreased cardiac function with New York Heart Association (NYHA) \> Class 2
* Uncontrolled or significant heart disorder such as unstable angina
* Significant abnormalities on electrocardiogram (ECG) at screening. Fridericia's correction formula for QT interval (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 colony stimulating factor 1 receptor (CSF1R) pathway inhibitors
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Five Prime Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Lead
Role: STUDY_DIRECTOR
Five Prime Therapeutics, Inc.
Locations
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Scottsdale Healthcare Hospitals DBA Honor Health
Scottsdale, Arizona, United States
Moores UC San Diego Cancer Center
La Jolla, California, United States
Norris Comprehensive Cancer Center, University of Southern California
Los Angeles, California, United States
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Center
Los Angeles, California, United States
UC Davis Comprehensive Cancer Center
Sacramento, California, United States
University of California, San Francisco
San Francisco, California, United States
Sarcoma Oncology Research Center
Santa Monica, California, United States
UCLA Hematology/Oncology- Santa Monica
Santa Monica, California, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Indiana University Health Hospital
Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Norton Cancer Institute, Norton Healthcare Pavilion
Louisville, Kentucky, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Allina Health, Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Memorial Sloan Kettering
New York, New York, United States
The Christ Hospital
Cincinnati, Ohio, United States
Providence Portland Medical Center
Portland, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute, William M. Cooper Ambulatory Pavilion of the Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Hollings Cancer Center, Medical University of South Carolina
Charleston, South Carolina, United States
Henry-Joyce Cancer Clinic, Vanderbilt-Ingram Cancer Center,
Nashville, Tennessee, United States
Baylor Charles A. Sammons Cancer Center, Baylor University Medical Center
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Mischer Neuroscience Associates, The University of Texas Health Science Center at Houston
Houston, Texas, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Cancer Therapy & Research Center, University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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FPA008-003
Identifier Type: -
Identifier Source: org_study_id
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