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 |
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.
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
12902 USF Magnolia Dr
Tampa, Florida 33612
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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666 Elm Street
Buffalo, New York 14263
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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86 Jonathan Lucas Street
Charleston, South Carolina 29425
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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3400 Spruce St
Philadelphia, Pennsylvania 19104
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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4805 Northeast Glisan Street
Portland, Oregon 97213
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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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
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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825 Eastlake Ave E
Seattle, Washington 98109
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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1364 Clifton Rd NE
Atlanta, Georgia 30322
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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450 Brookline Ave
Boston, Massachusetts 2215
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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1653 W. Congress Parkway
Chicago, Illinois 60612
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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5841 S Maryland Ave
Chicago, Illinois 60637
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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2139 Auburn Ave
Cincinnati, Ohio 45219
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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3410 Worth Street
Dallas, Texas 75246
Dallas, Texas 75246
Principal Investigator: Karen Fink, MD, PhD
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1801 Inwood Rd
Dallas, Texas 75390
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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2799 W Grand Blvd
Detroit, Michigan 48202
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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6411 Fannin Street
Houston, Texas 77030
Houston, Texas 77030
Principal Investigator: Jay-Jiguang Zhu, MD
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1515 Holcombe Blvd
Houston, Texas 77030
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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Indianapolis, Indiana 46202
Principal Investigator: Bert H. O'Neil, MD
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200 Hawkins Dr,
Iowa City, Iowa 52242
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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La Jolla, California 92093
Principal Investigator: Sandip Patel, MD
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Los Angeles, California 90033
Principal Investigator: Anthony El-Khoueiry, MD
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8700 Beverly Boulevard
Los Angeles, California 90048
Los Angeles, California 90048
Principal Investigator: Alain Mita, MD
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Louisville, Kentucky 40202
Principal Investigator: John T. Hamm, MD
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Miami Beach, Florida 33140
Principal Investigator: Jose Lutzsky, MD
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Minneapolis, Minnesota 55407
Principal Investigator: Michaela L. Tsai, MD
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1301 Medical Center Drive
Nashville, Tennessee 37232
Nashville, Tennessee 37232
Principal Investigator: Emily Chan, MD
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111 S 11th St
Philadelphia, Pennsylvania 19107
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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Pittsburgh, Pennsylvania 15232
Principal Investigator: James J. Lee, MD, PhD
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4501 X St
Sacramento, California 95817
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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San Antonio, Texas 78229
Principal Investigator: Drew W Rasco, MD
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San Antonio, Texas 78229
Principal Investigator: Andrew Brenner, MD
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San Francisco, California 94143
Principal Investigator: Nicholas A Butowski, MD
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Santa Monica, California 90403
Principal Investigator: Sant P. Chawla, MD
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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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