Ipilimumab With or Without Nivolumab in Treating Patients With Melanoma That Is Stage IV or Stage III and Cannot Be Removed by Surgery



Status:Recruiting
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/4/2019
Start Date:July 17, 2017
End Date:March 15, 2022

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A Phase II Randomized Study of Nivolumab (NSC-748726) With Ipilimumab (NSC-732442) or Ipilimumab Alone in Advanced Melanoma Patients Refractory to an Anti-PD1 or Anti-PD-L1 Agent

This phase II trial studies how well ipilimumab with or without nivolumab work in treating
patients with melanoma that is stage IV or stage III and cannot be removed by surgery.
Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the
body's immune system attack the cancer, and may interfere with the ability of tumor cells to
grow and spread.

PRIMARY OBJECTIVES:

I. To compare progression free survival (PFS) of patients with advanced melanoma refractory
to an anti-PD-1 or anti-PD-L1 agent, treated with combination therapy ipilimumab plus
nivolumab versus ipilimumab alone.

SECONDARY OBJECTIVES:

I. To estimate difference in T-cell infiltrate between on-study biopsy samples of patients
who respond to combination therapy (including confirmed and unconfirmed, complete and partial
response per Response Evaluation Criteria in Solid Tumors [RECIST] 1.1, in each treatment
arm).

II. To evaluate the objective response rate (ORR), defined as confirmed complete or partial
response per RECIST 1.1, in each treatment arm.

III. To evaluate the overall survival (OS) of patients in each treatment arm. IV. To evaluate
the toxicity profile of patients in each treatment arm.

TRANSITIONAL OBJECTIVES:

I. To assess the marginal prognostic value of baseline T-cell density, T-cell receptor (TCR)
clonality, mutational load, and messenger ribonucleic acid (mRNA) expression levels in terms
of response.

II. To assess the joint prognostic value of T-cell density, TCR clonality, and mutational
load, and mRNA expression levels in terms of response.

III. To identify T-cell poor subtype(s) that are associated with response.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive ipilimumab intravenously (IV) over 90 minutes on day 1. Treatment
repeats every 21 days for up to 4 cycles in the absence of disease progression or
unacceptable toxicity.

ARM II: Patients receive nivolumab IV over 60 minutes and ipilimumab IV over 90 minutes on
day 1. Treatment repeats every 21 days for up to 4 cycles in the absence of disease
progression or unacceptable toxicity. Patients then receive nivolumab IV over 60 minutes on
days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or
unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for 2 years and
then annually for 1 year.

Inclusion Criteria:

- Patients must have pathologically confirmed melanoma that is either stage IV or
unresectable stage III; patients may have primaries of cutaneous, mucosal or unknown
origin; patients with uveal (ocular) primary are not eligible

- Patients must have measurable disease per RECIST 1.1; all measurable lesions must be
assessed by physical examination, computed tomography (CT) scans or magnetic resonance
imaging (MRI)s within 28 days prior to registration; if the only measurable disease is
cutaneous or subcutaneous, lesions must be at least 10 mm in greatest dimension and
able to be serially recorded using calipers and photographs; tests used to assess
non-measurable disease must have been performed within 42 days prior to registration;
all disease must be assessed and documented on the Baseline Tumor Assessment Form

- Patients with central nervous system (CNS) metastases must have all lesions adequately
treated with stereotactic radiation therapy, craniotomy, gamma knife therapy, or whole
brain radiotherapy, with no subsequent evidence of CNS progression; patients must not
have required steroids for at least 14 days prior to registration; patients with a
history of central nervous system metastases must have MRI of the brain within 42 days
prior to registration

- Patients must have had prior treatment with anti-PD1 or anti-PD-L1 agents and had
documented disease progression per the treating physician either while on these agents
or after stopping therapy with these agents without intervening therapy; patients who
received adjuvant therapy for previously resected disease with PD-1 or PD-L1 agents
may also be eligible if disease recurrence occurred while still receiving the PD-1 or
PD-L1 therapy and no intervening therapy was received; patients must have discontinued
anti-PD-1 or anti-PD-L1 therapy at least 21 days prior to registration

- Patients must not have achieved a partial or complete response to the anti-PD-1 or
anti-PD-L1 agents prior to progression per the treating physician

- Patients must not have had any systemic therapy, including anti-PD-1 or anti-PD-L1
agents, within 21 days prior to registration

- Patients must not have had prior radiation therapy within 14 days prior to
registration

- Patients must not have had:

- Prior treatment with ipilimumab or other CTLA-4 antagonists

- Systemic therapy between progression on the anti-PD-1 or anti-PD-L1 agents and
registration

- Note: Systemic therapy (including BRAF-targeting agents) prior to anti-PD-1 or
anti-PD-L1 therapy is allowed

- Patients must not be planning to require any additional form of systemic anti-tumor
therapy while on protocol treatment

- Patients must have Zubrod performance status of =< 2

- Patients must have complete history and physical examination within 28 days prior to
registration

- Absolute neutrophil count (ANC) >= 1,500/mcL (within 28 days prior to registration)

- Hemoglobin >= 8 g/dL (within 28 days prior to registration)

- Platelets >= 100,000/mcL (within 28 days prior to registration)

- Total bilirubin =< 2.5 x institutional upper limit of normal (IULN) (except patients
with Gilbert's syndrome) (within 28 days prior to registration)

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both =< 5 x IULN
(within 28 days prior to registration)

- Serum creatinine =< 2.0 x IULN within 28 days prior to registration

- Patients with a known history of human immunodeficiency virus (HIV) must have CD4
count >= institutional lower limit of normal within 28 days prior to registration

- Patients must not have known active hepatitis B virus (HBV) or hepatitis C virus (HCV)
infection prior to registration

- Patients must not have an active infection requiring systemic therapy at time of
registration

- Patients must not have organ allografts

- Patients must not have received systemic treatment with corticosteroids (> 10 mg daily
prednisone or equivalent) or other immunosuppressive medications within 14 days prior
to registration; inhaled or topical steroids, and adrenal replacement doses =< 10 mg
daily prednisone or equivalent are permitted in the absence of active autoimmune
disease

- Patients must not have a history of immune-mediated pneumonitis or colitis that
required interruption of therapy or treatment of steroids

- Patients with a known history of congestive heart failure (CHF), cardiomyopathy,
myocarditis, myocardial infarction (MI), exposure to cardiotoxic medications, or with
a clinical history suggestive of the above must have an electrocardiography (EKG) and
echocardiogram (ECHO) performed within 42 days prior to registration and as clinically
indicated while on treatment

- Patients with new symptoms of congestive heart failure (CHF), cardiomyopathy,
myocarditis, myocardial infarction (MI), or exposure to cardiotoxic medications must
have a cardiology consultation, creatinine phosphokinase (CPK), and troponin testing
at prestudy and as clinically indicated

- No other prior malignancy is allowed except for the following: adequately treated
basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated
stage 0, I or II cancer from which the patient is currently in complete remission, or
any other cancer from which the patient has been disease free for two years

- Patients must not be pregnant or nursing due to risk of fetal or nursing infant harm;
females of reproductive potential must have negative serum pregnancy test within 2
days prior to registration and agree to use an effective contraceptive method
throughout the study and for 5 months after completion of protocol treatment; a woman
is considered to be of "reproductive potential" if she has had menses at any time in
the preceding 12 consecutive months; in addition to routine contraceptive methods,
"effective contraception" also includes heterosexual celibacy and surgery intended to
prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a
hysterectomy, bilateral oophorectomy or bilateral tubal ligation; if at any point a
previously celibate patient chooses to become heterosexually active during or within 5
months after protocol treatment, she is responsible for beginning effective
contraceptive measures

- Males who are sexually active with women of reproductive potential must have agreed to
use birth control throughout the study and for 7 months after completion of protocol
treatment; in addition to routine contraceptive methods, "effective contraception"
also includes heterosexual celibacy and surgery intended to prevent pregnancy
(vasectomy); if at any point a previously celibate patient chooses to become
heterosexually active during or within 7 months after completion of protocol
treatment, he is responsible for beginning effective contraceptive measures

- Patients must submit archival tissue (if available) for translational medicine;
patients must also be willing to undergo biopsies and submit fresh tissue and blood
for translational medicine

- Patients must be offered the opportunity to participate in specimen banking of
leftover tissue for future research

- Patients must be informed of the investigational nature of this study and must sign
and give written informed consent in accordance with institutional and federal
guidelines

- As a part of the Oncology Patient Enrollment Network (OPEN) registration process the
treating institution's identity is provided in order to ensure that the current
(within 365 days) date of institutional review board approval for this study has been
entered in the system
We found this trial at
552
sites
1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
Principal Investigator: Emrullah Yilmaz
Phone: 505-925-0366
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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361 Old Belgrade Road
Augusta, Maine 04330
(207) 621-6100
Principal Investigator: Peter Rubin
Phone: 207-626-4855
Harold Alfond Center for Cancer Care MaineGeneral's Harold Alfond Center for Cancer Care (HACCC) is...
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Bremerton, Washington 98310
Principal Investigator: Richard L. Deming
Phone: 308-398-6518
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Principal Investigator: Igor Puzanov
Phone: 800-767-9355
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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1500 E Duarte Rd
Duarte, California 91010
(626) 256-4673
Principal Investigator: Kim A. Margolin
Phone: 800-826-4673
City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
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4725 North Federal Highway
Fort Lauderdale, Florida 33308
(954) 771-8000
Principal Investigator: Jose Lutzky
Phone: 954-267-7750
Holy Cross Hospital While spirituality plays an essential role in the way that we minister...
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100 Michigan Street Northeast
Grand Rapids, Michigan 49503
616.391.9000
Principal Investigator: Kathleen J. Yost
Helen DeVos Children's Hospital at Spectrum Health Helen DeVos Children's Hospital, located in Grand Rapids,...
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524 South Park Street
Kalamazoo, Michigan 49007
(269) 341-7654
Principal Investigator: Kathleen J. Yost
Phone: 616-391-1230
Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
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200 North Park Street
Kalamazoo, Michigan 49007
(269) 382-2500
Principal Investigator: Kathleen J. Yost
Phone: 616-391-1230
West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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1800 West Charleston Boulevard
Las Vegas, Nevada 89102
(702) 383-2000
Principal Investigator: John A. Ellerton
Phone: 702-384-0013
University Medical Center of Southern Nevada University Medical Center is dedicated to providing the highest...
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4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Principal Investigator: Gary E. Goodman
Phone: 503-215-2614
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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60 Crittenden Blvd # 70
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Paul M. Barr
Phone: 585-275-5830
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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Seattle, Washington 98104
Principal Investigator: Gary E. Goodman
Phone: 206-215-3086
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808 North 39th Avenue
Yakima, Washington 98902
Principal Investigator: John A. Keech
Phone: 509-574-3535
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'Aiea, Hawaii 96701
Principal Investigator: Jeffrey L. Berenberg
Phone: 808-487-7447
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98-1079 Moanalua Road
'Aiea, Hawaii 96701
Principal Investigator: Jeffrey L. Berenberg
Phone: 808-486-6000
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2226 Liliha Street
'Aiea, Hawaii 96701
Principal Investigator: Jeffrey L. Berenberg
Phone: 808-678-9000
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'Aiea, Hawaii 96701
Principal Investigator: Jeffrey L. Berenberg
Phone: 808-539-2273
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Aberdeen, Washington 98520
Principal Investigator: Gary E. Goodman
Phone: 360-412-8958
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1200 Old York Road
Abington, Pennsylvania 19001
(215) 481–2000
Principal Investigator: Willard G. Andrews
Phone: 215-481-2402
Abington Memorial Hospital Abington Memorial Hospital (AMH) is a 665-bed, regional referral center and teaching...
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Adrian, Michigan 49221
Principal Investigator: Rex B. Mowat
Phone: 517-265-0116
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Albuquerque, New Mexico 87102
Principal Investigator: Emrullah Yilmaz
Phone: 505-272-0530
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Anaconda, Montana 59711
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
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Anchorage, Alaska 98508
Principal Investigator: Gary E. Goodman
Phone: 907-212-6871
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Anchorage, Alaska 99508
Principal Investigator: Gary E. Goodman
Phone: 907-212-6871
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Anchorage, Alaska 99508
Principal Investigator: Gary E. Goodman
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Anchorage, Alaska 99508
Principal Investigator: Gary E. Goodman
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Anchorage, Alaska 99508
Principal Investigator: Gary E. Goodman
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Anchorage, Alaska 99508
Principal Investigator: Gary E. Goodman
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Anchorage, Alaska 99508
Principal Investigator: Gary E. Goodman
Phone: 907-212-6871
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Anchorage, Alaska 99504
Principal Investigator: Gary E. Goodman
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Antioch, California 94531
Principal Investigator: Tatjana Kolevska
Phone: 877-642-4691
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921 North Oak Park Boulevard
Arroyo Grande, California 93420
Principal Investigator: John A. Ellerton
Phone: 702-384-0013
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1625 Maple Lane
Ashland, Wisconsin 54806
Principal Investigator: Bret E. Friday
Phone: 218-786-3308
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Ashland, Wisconsin 54806
Principal Investigator: Bret E. Friday
Phone: 218-786-3308
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Auburn, California 95602
Principal Investigator: Edmund W. Tai
Phone: 415-209-2686
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Auburn, California 95603
Principal Investigator: Edmund W. Tai
Phone: 415-209-2686
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Auburn, Washington 98001
Principal Investigator: John A. Keech
Phone: 253-887-9333
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Aurora, Colorado 80012
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
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12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
Principal Investigator: Steven R. Schuster
Phone: 720-848-0650
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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1501 S Potomac St
Aurora, Colorado 80012
(303) 695-2600
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
Medical Center of Aurora At The Medical Center of Aurora and Centennial Medical Plaza patients...
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2000 Ogden Ave
Aurora, Illinois 60504
(630) 978-6200
Principal Investigator: Kendrith M. Rowland
Phone: 630-978-6212
Rush - Copley Medical Center Rush-Copley is proud to be the leading provider of health...
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Aventura, Florida 33180
Principal Investigator: Jose Lutzky
Phone: 305-674-2625
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Bainbridge Island, Washington 98110
Principal Investigator: John A. Keech
Phone: 206-342-6954
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3325 Pocahontas Road
Baker City, Oregon 97814
Principal Investigator: Benjamin T. Marchello
Phone: 734-712-3671
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Ballwin, Missouri 63011
Principal Investigator: Jay W. Carlson
Phone: 314-251-7058
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4305 New Shepherdsville Road
Bardstown, Kentucky 40004
Principal Investigator: Richard L. Deming
Phone: 308-398-6518
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265 Fremont St
Battle Creek, Michigan 49017
(269) 245-8166
Principal Investigator: Kathleen J. Yost
Phone: 616-391-1230
Bronson Battle Creek As a proud member of the Battle Creek community, we believe everyone...
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3535 Pentagon Boulevard
Beavercreek, Ohio 45431
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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118 Northport Avenue
Belfast, Maine 04915
Principal Investigator: Peter Rubin
Phone: 207-338-2500
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Bellevue, Washington 98004
Principal Investigator: John A. Keech
Phone: 425-688-5407
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Bellingham, Washington 98225
Principal Investigator: Gary E. Goodman
Phone: 360-715-4133
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800 Farson Street
Belpre, Ohio 45714
(740) 401-0417
Principal Investigator: Timothy D. Moore
Phone: 800-523-3977
Strecker Cancer Center-Belpre The Memorial Health System's Strecker Cancer Center, Belpre combines the clinical expertise...
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Bend, Oregon 97701
Principal Investigator: Gary E. Goodman
Phone: 541-706-2909
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Berkeley, California 94704
Principal Investigator: Edmund W. Tai
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Biddeford, Maine 04005
Principal Investigator: Peter Rubin
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Billings, Montana 59101
Principal Investigator: Benjamin T. Marchello
Phone: 800-996-2663
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1233 North 30th Street
Billings, Montana 59101
406-237-7000
Principal Investigator: Keren Sturtz
Phone: 406-969-6060
Saint Vincent Healthcare The Sisters of Charity of Leavenworth, Kansas, founded St. Vincent Healthcare in...
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Billings, Montana 59102
Principal Investigator: Keren Sturtz
Phone: 800-648-6274
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Boardman, Ohio 44512
Principal Investigator: Howard M. Gross
Phone: 330-629-7500
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100 E Idaho St
Boise, Idaho 83712
(208) 381-2711
Principal Investigator: Gary E. Goodman
Phone: 907-212-6871
Saint Luke's Mountain States Tumor Institute For more than 100 years, St. Luke
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Boise, Idaho 83706
Principal Investigator: Benjamin T. Marchello
Phone: 734-712-3671
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Bolivar, Missouri 65613
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1100 Balsam Ave
Boulder, Colorado 80304
(303) 440-2273
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
Boulder Community Hospital Founded in 1922 as a community-owned and operated not-for-profit hospital, Boulder Community...
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Boulder, Colorado 80303
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
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915 Highland Blvd
Bozeman, Montana 59715
(406) 414-5000
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
Bozeman Deaconess Hospital Bozeman Deaconess Hospital is a Joint Commission certified, licensed Level III trauma...
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Brainerd, Minnesota 56401
Principal Investigator: Bret E. Friday
Phone: 888-203-7267
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Branson, Missouri 65616
Principal Investigator: Jay W. Carlson
Phone: 417-269-4520
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Bremerton, Washington 98310
Principal Investigator: Richard L. Deming
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Bridgeport, West Virginia 26330
Principal Investigator: Joanna A. Kolodney
Phone: 304-293-7374
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Bryan, Texas 77802
Principal Investigator: Richard L. Deming
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Burbank, California
Principal Investigator: Gary E. Goodman
Phone: 818-847-4793
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Burien, Washington 98166
Principal Investigator: Richard L. Deming
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1501 Trousdale Drive
Burlingame, California 94010
Principal Investigator: Edmund W. Tai
Phone: 650-696-4487
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Burlington, Massachusetts 01805
Principal Investigator: Krishna S. Gunturu
Phone: 781-744-8027
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Burlington, Wisconsin 53105
Principal Investigator: Manish K. Pant
Phone: 414-302-2304
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201 E Nicollet Blvd
Burnsville, Minnesota 55337
(952) 892-2000
Principal Investigator: David M. King
Phone: 952-993-1517
Fairview Ridges Hospital Fairview Ridges Hospital is a 150-bed, Level III Trauma Care facility, offering...
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400 South Clark Street
Butte, Montana 59701
406-723-2500
Principal Investigator: Keren Sturtz
Phone: 406-723-2621
Saint James Community Hospital and Cancer Treatment Center St. James Healthcare has played an important...
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3123 Medical Dr
Caldwell, Idaho 83605
Principal Investigator: Benjamin T. Marchello
Phone: 734-712-3671
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Camden, New Jersey 08103
Principal Investigator: Nati Lerman
Phone: 856-325-6757
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Cameron Park, California 95682
Principal Investigator: Edmund W. Tai
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Carson City, Nevada 89703
Principal Investigator: John A. Ellerton
Phone: 702-384-0013
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Castro Valley, California 94546
Principal Investigator: Edmund W. Tai
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Cedar Rapids, Iowa 52401
Principal Investigator: William P. Fusselman
Phone: 319-297-2900
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Cedar Rapids, IA
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Centerville, Ohio 45459
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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mi
from
Centerville, OH
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Centerville, Ohio 45459
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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mi
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Centerville, OH
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Centralia, Washington 98531
Principal Investigator: Gary E. Goodman
Phone: 360-412-8958
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mi
from
Centralia, WA
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Chapel Hill, North Carolina 27599
Principal Investigator: Frances A. Collichio
Phone: 877-668-0683
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mi
from
Chapel Hill, NC
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3110 MacCorkle Avenue Southeast
Charleston, West Virginia 25304
Principal Investigator: Steven J. Jubelirer
Phone: 304-388-9944
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mi
from
Charleston, WV
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Chattanooga, Tennessee 37404
Principal Investigator: Richard L. Deming
Phone: 308-398-6518
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mi
from
Chattanooga, TN
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Cheyenne, Wyoming 82001
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
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mi
from
Cheyenne, WY
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303 East Superior Street
Chicago, Illinois 60611
Principal Investigator: Jeffrey A. Sosman
Phone: 312-695-1301
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mi
from
Chicago, IL
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272 Hospital Rd
Chillicothe, Ohio 45601
740-779-7500
Principal Investigator: Timothy D. Moore
Phone: 877-779-7585
Adena Regional Medical Center Since 1895, Adena Health System has remained focused on its commitment...
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mi
from
Chillicothe, OH
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12961 27th Ave
Chippewa Falls, Wisconsin 54729
715-738-3700
Principal Investigator: Demet Gokalp Yasar
Phone: 800-782-8581
Marshfield Clinic - Chippewa Center The 15,000 square foot Lake Hallie Center provides urgent care...
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mi
from
Chippewa Falls, WI
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Cincinnati, Ohio 45220
Principal Investigator: Richard L. Deming
Phone: 308-398-6518
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mi
from
Cincinnati, OH
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Cincinnati, Ohio 45236
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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mi
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Cincinnati, OH
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Cincinnati, Ohio 45242
Principal Investigator: Richard L. Deming
Phone: 308-398-6518
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mi
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Cincinnati, OH
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Cincinnati, Ohio 45247
Principal Investigator: Richard L. Deming
Phone: 308-398-6518
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mi
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Cincinnati, OH
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Cincinnati, Ohio 45255
Principal Investigator: Richard L. Deming
Phone: 308-398-6518
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mi
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Cincinnati, OH
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9280 SE Sunnybrook Blvd #100
Clackamas, Oregon 97015
(503) 513-3300
Principal Investigator: Gary E. Goodman
Phone: 503-215-2614
Clackamas Radiation Oncology Center State-of-the-art technology and compassionate care come together at Clackamas Radiation Oncology...
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mi
from
Clackamas, OR
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Clackamas, Oregon 97015
Principal Investigator: Gary E. Goodman
Phone: 503-215-2614
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mi
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Clackamas, OR
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