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



Status:Active, not recruiting
Conditions:Lung Cancer, Colorectal Cancer, Colorectal Cancer, Skin Cancer, Ovarian Cancer, Cancer, Cancer, Cancer, Cancer, Brain Cancer, Pancreatic Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/3/2018
Start Date:September 2015
End Date:March 2020

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A Phase 1a/1b Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers

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.


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
We found this trial at
39
sites
2139 Auburn Ave
Cincinnati, Ohio 45219
(513) 585-2000
Principal Investigator: Philip D. Leming, MD
The Christ Hospital For more than 120 years, The Christ Hospital has been a leader...
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Cincinnati, OH
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Principal Investigator: Mateusz Opyrchal, MD, PhD
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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Buffalo, NY
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86 Jonathan Lucas Street
Charleston, South Carolina 29425
(843) 792-0700
Principal Investigator: Carolyn Britten, MD
Hollings Cancer Center at Medical University of South Carolina Located at the Medical University of...
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Charleston, SC
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Principal Investigator: Peter O'Dwyer, MD
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Philadelphia, PA
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4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Principal Investigator: Rachel Sanborn, MD
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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Portland, OR
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Matthew Taylor, MD
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Principal Investigator: John Thompson, MD
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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Seattle, WA
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12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
Principal Investigator: Heloisa Soares, MD,PhD
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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Tampa, FL
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Principal Investigator: Bassel El-Rayes, MD
Emory University Hospital As the largest health care system in Georgia and the only health...
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Atlanta, GA
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Baltimore, MD
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Frank S. Hodi, MD
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Nicklas Pfanzelter, MD
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chicago, IL
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
Principal Investigator: Jason J Luke, MD
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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Chicago, IL
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3410 Worth Street
Dallas, Texas 75246
Principal Investigator: Karen Fink, MD, PhD
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Dallas, TX
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Principal Investigator: Muhammad S Beg, MD
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Dallas, TX
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Detroit, Michigan 48201
Principal Investigator: Amy M. Weise, MD
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Detroit, MI
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Principal Investigator: Ding Wang, MD, PhD
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Detroit, MI
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6411 Fannin Street
Houston, Texas 77030
Principal Investigator: Jay-Jiguang Zhu, MD
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Houston, TX
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
Principal Investigator: Sarina A. Piha-Paul, MD
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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Indianapolis, Indiana 46202
Principal Investigator: Bert H. O'Neil, MD
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Indianapolis, IN
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
Principal Investigator: Mohammed Milhem, MD
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Iowa City, IA
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La Jolla, California 92093
Principal Investigator: Sandip Patel, MD
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La Jolla, CA
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Los Angeles, California 90033
Principal Investigator: Anthony El-Khoueiry, MD
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Los Angeles, CA
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8700 Beverly Boulevard
Los Angeles, California 90048
Principal Investigator: Alain Mita, MD
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Los Angeles, CA
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Louisville, Kentucky 40202
Principal Investigator: John T. Hamm, MD
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Louisville, KY
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Miami Beach, Florida 33140
Principal Investigator: Jose Lutzsky, MD
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Miami Beach, FL
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Minneapolis, Minnesota 55407
Principal Investigator: Michaela L. Tsai, MD
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Minneapolis, MN
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1301 Medical Center Drive
Nashville, Tennessee 37232
Principal Investigator: Emily Chan, MD
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Nashville, TN
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New York, New York 10065
Principal Investigator: Mariza Daras, MD
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New York, NY
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111 S 11th St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: Jennifer Johnson, MD
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
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Philadelphia, PA
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Pittsburgh, Pennsylvania 15232
Principal Investigator: James J. Lee, MD, PhD
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4501 X St
Sacramento, California 95817
(916) 734-5800
Principal Investigator: Karen Kelly, MD
UC Davis Comprehensive Cancer Center When faced with cancer, you want the best hope for...
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Sacramento, CA
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Salt Lake City, Utah 84112
Principal Investigator: Sunil Sharma, MD
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Salt Lake City, UT
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San Antonio, Texas 78229
Principal Investigator: Drew W Rasco, MD
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San Antonio, TX
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San Antonio, Texas 78229
Principal Investigator: Andrew Brenner, MD
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San Antonio, TX
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San Francisco, California 94143
Principal Investigator: Nicholas A Butowski, MD
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San Francisco, CA
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Santa Monica, California 90403
Principal Investigator: Sant P. Chawla, MD
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Santa Monica, CA
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Santa Monica, California 90404
Principal Investigator: Zev A. Wainberg, MD
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Scottsdale, Arizona 85258
Principal Investigator: Michael S Gordon, MD
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