cropped color_logo_with_background.png

Clinical Trial Finder

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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

  • - 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT02526017
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Five Prime Therapeutics, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Medical Lead
Principal Investigator Affiliation Five Prime Therapeutics, Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Advanced Solid Tumors, Head and Neck Cancer, Pancreatic Cancer, Ovarian Cancer, Renal Cell Carcinoma, Malignant Glioma, Non-small Cell Lung Cancer
Additional Details

This is a phase 1a/b single-arm, open-label study to evaluate safety, tolerability, pharmacokinetics (PK), and clinical benefit of cabiralizumab in combination with nivolumab in patients with selected advanced cancers.

Arms & Interventions

Arms

Experimental: 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.

Experimental: 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.

Experimental: 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.

Interventions

Biological: - Cabiralizumab

Solution for IV administration

Biological: - Nivolumab

Solution for IV administration

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Scottsdale, Arizona

Status

Address

Scottsdale Healthcare Hospitals DBA Honor Health

Scottsdale, Arizona, 85258

Moores UC San Diego Cancer Center, La Jolla, California

Status

Address

Moores UC San Diego Cancer Center

La Jolla, California, 92093

Los Angeles, California

Status

Address

Norris Comprehensive Cancer Center, University of Southern California

Los Angeles, California, 90033

Los Angeles, California

Status

Address

Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Center

Los Angeles, California, 90048

UC Davis Comprehensive Cancer Center, Sacramento, California

Status

Address

UC Davis Comprehensive Cancer Center

Sacramento, California, 95817

University of California, San Francisco, San Francisco, California

Status

Address

University of California, San Francisco

San Francisco, California, 94143

Sarcoma Oncology Research Center, Santa Monica, California

Status

Address

Sarcoma Oncology Research Center

Santa Monica, California, 90403

UCLA Hematology/Oncology- Santa Monica, Santa Monica, California

Status

Address

UCLA Hematology/Oncology- Santa Monica

Santa Monica, California, 90404

Mount Sinai Comprehensive Cancer Center, Miami Beach, Florida

Status

Address

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, 33140

Tampa, Florida

Status

Address

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612

Emory University Hospital, Atlanta, Georgia

Status

Address

Emory University Hospital

Atlanta, Georgia, 30322

Rush University Medical Center, Chicago, Illinois

Status

Address

Rush University Medical Center

Chicago, Illinois, 60612

University of Chicago Medical Center, Chicago, Illinois

Status

Address

University of Chicago Medical Center

Chicago, Illinois, 60637

Indiana University Health Hospital, Indianapolis, Indiana

Status

Address

Indiana University Health Hospital

Indianapolis, Indiana, 46202

University of Iowa Hospitals and Clinics, Iowa City, Iowa

Status

Address

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242

Louisville, Kentucky

Status

Address

Norton Cancer Institute, Norton Healthcare Pavilion

Louisville, Kentucky, 40202

Baltimore, Maryland

Status

Address

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21287

Dana Farber Cancer Institute, Boston, Massachusetts

Status

Address

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

Karmanos Cancer Institute, Detroit, Michigan

Status

Address

Karmanos Cancer Institute

Detroit, Michigan, 48201

Henry Ford Hospital, Detroit, Michigan

Status

Address

Henry Ford Hospital

Detroit, Michigan, 48202

Minneapolis, Minnesota

Status

Address

Allina Health, Virginia Piper Cancer Institute

Minneapolis, Minnesota, 55407

Roswell Park Cancer Institute, Buffalo, New York

Status

Address

Roswell Park Cancer Institute

Buffalo, New York, 14263

Memorial Sloan Kettering, New York, New York

Status

Address

Memorial Sloan Kettering

New York, New York, 10065

The Christ Hospital, Cincinnati, Ohio

Status

Address

The Christ Hospital

Cincinnati, Ohio, 45219

Providence Portland Medical Center, Portland, Oregon

Status

Address

Providence Portland Medical Center

Portland, Oregon, 97213

Oregon Health and Science University, Portland, Oregon

Status

Address

Oregon Health and Science University

Portland, Oregon, 97239

Philadelphia, Pennsylvania

Status

Address

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Thomas Jefferson University Hospital, Philadelphia, Pennsylvania

Status

Address

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107

Pittsburgh, Pennsylvania

Status

Address

University of Pittsburgh Cancer Institute, William M. Cooper Ambulatory Pavilion of the Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232

Charleston, South Carolina

Status

Address

Hollings Cancer Center, Medical University of South Carolina

Charleston, South Carolina, 29425

Nashville, Tennessee

Status

Address

Henry-Joyce Cancer Clinic, Vanderbilt-Ingram Cancer Center,

Nashville, Tennessee, 37232

Dallas, Texas

Status

Address

Baylor Charles A. Sammons Cancer Center, Baylor University Medical Center

Dallas, Texas, 75246

Dallas, Texas

Status

Address

University of Texas Southwestern Medical Center

Dallas, Texas, 75390

Houston, Texas

Status

Address

Mischer Neuroscience Associates, The University of Texas Health Science Center at Houston

Houston, Texas, 77030

Houston, Texas

Status

Address

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030

San Antonio, Texas

Status

Address

Cancer Therapy & Research Center, University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229

San Antonio, Texas

Status

Address

South Texas Accelerated Research Therapeutics, LLC

San Antonio, Texas, 78229

Huntsman Cancer Institute, Salt Lake City, Utah

Status

Address

Huntsman Cancer Institute

Salt Lake City, Utah, 84112

Seattle Cancer Care Alliance, Seattle, Washington

Status

Address

Seattle Cancer Care Alliance

Seattle, Washington, 98109

Powered By