Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers

Completed · Phase 1

Conditions studied: Advanced Solid Tumors, Head and Neck Cancer, Pancreatic Cancer, Ovarian Cancer, Renal Cell Carcinoma, Malignant Glioma, Non-small Cell Lung Cancer

In brief

Phase 1a/1b does-escalation study of cabiralizumab alone and with nivolumab in advanced solid tumors.

Key facts

Study ID

NCT02526017

Run by

Five Prime Therapeutics, Inc.

People needed

313

Starts

2015-09-08

Expected to finish

2019-11-18

Last updated by the study team

2022-03-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have at least one measurable lesion at baseline by computed tomography (CT) or magnetic resonance imaging (MRI) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 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

You may not qualify if…

• Current or history of clinically significant muscle disorders (e.g., myositis), recent unresolved muscle injury, or any condition known to elevate serum creatine kinase (CK) levels
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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