Nivolumab and Ipilimumab in Treating Patients With Rare Tumors



Status:Recruiting
Conditions:Breast Cancer, Skin Cancer, Ovarian Cancer, Cervical Cancer, Liver Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Brain Cancer, Brain Cancer, Neurology
Therapuetic Areas:Neurology, Oncology
Healthy:No
Age Range:18 - Any
Updated:4/4/2019
Start Date:January 13, 2017

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DART: Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors

This clinical trial studies nivolumab and ipilimumab in treating patients with rare tumors.
Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere with the ability of
tumor cells to grow and spread.

This trial enrolls participants for the following cohorts based on condition:

1. Epithelial tumors of nasal cavity, sinuses, nasopharynx: A) Squamous cell carcinoma with
variants of nasal cavity, sinuses, and nasopharynx and trachea (excluding laryngeal,
nasopharyngeal cancer [NPC], and squamous cell carcinoma of the head and neck [SCCHN])
B) Adenocarcinoma and variants of nasal cavity, sinuses, and nasopharynx.

2. Epithelial tumors of major salivary glands

3. Salivary gland type tumors of head and neck, lip, esophagus, stomach, trachea and lung,
breast and other location

4. Undifferentiated carcinoma of gastrointestinal (GI) tract

5. Adenocarcinoma with variants of small intestine

6. Squamous cell carcinoma with variants of GI tract (stomach small intestine, colon,
rectum, pancreas)

7. Fibromixoma and low grade mucinous adenocarcinoma (pseudomixoma peritonei) of the
appendix and ovary

8. Rare pancreatic tumors including acinar cell carcinoma, mucinous cystadenocarcinoma or
serous cystadenocarcinoma

9. Intrahepatic Cholangiocarcinoma

10. Extrahepatic cholangiocarcinoma and bile duct tumors

11. Sarcomatoid carcinoma of lung

12. Bronchoalveolar carcinoma lung. This condition is now also referred to as adenocarcinoma
in situ, minimally invasive adenocarcinoma, lepidic predominant adenocarcinoma, or
invasive mucinous adenocarcinoma.

13. Non-epithelial tumors of the ovary: A) Germ cell tumor of ovary B) Mullerian mixed tumor
and adenosarcoma

14. Trophoblastic tumor: A) Choriocarcinoma

15. Transitional cell carcinoma other than that of the renal, pelvis, ureter, or bladder

16. Cell tumor of the testes and extragonadal germ tumors: A) Seminoma and testicular sex
cord cancer B) Non seminomatous tumor C) Teratoma with malignant transformation

17. Epithelial tumors of penis - squamous adenocarcinoma cell carcinoma with variants of
penis

18. Squamous cell carcinoma variants of the genitourinary (GU) system

19. Spindle cell carcinoma of kidney, pelvis, ureter

20. Adenocarcinoma with variants of GU system (excluding prostate cancer)

21. Odontogenic malignant tumors

22. Endocrine carcinoma of pancreas and digestive tract

23. Neuroendocrine carcinoma including carcinoid of the lung

24. Pheochromocytoma, malignant

25. Paraganglioma

26. Carcinomas of pituitary gland, thyroid gland parathyroid gland and adrenal cortex

27. Desmoid tumors

28. Peripheral nerve sheath tumors and NF1-related tumors

29. Malignant giant cell tumors

30. Chordoma

31. Adrenal cortical tumors

32. Tumor of unknown primary (Cancer of Unknown Primary; CuP)

33. Not Otherwise Categorized (NOC) Rare Tumors [To obtain permission to enroll in the NOC
cohort, contact: S1609SC@swog.org]

34. Adenoid cystic carcinoma

35. Vulvar cancer

36. MetaPLASTIC carcinoma (of the breast)

37. Gastrointestinal stromal tumor (GIST)

PRIMARY OBJECTIVES:

I. To evaluate the Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
overall response rate (ORR) in subsets of patients with advanced rare cancers treated with
ipilimumab plus nivolumab combination immunotherapy.

SECONDARY OBJECTIVES:

I. To evaluate toxicities in each cohort. II. To estimate overall survival (OS),
progression-free survival (PFS), clinical benefit rate; and to estimate immune-related ORR
(irORR), and immune-related PFS (irPFS) by unidimensional immune-related response criteria.

TERTIARY OBJECTIVES:

I. To evaluate the association of tumor mutational burden measured by tissue sequencing with
durable response (complete response [CR] or partial response [PR] lasting 24 weeks or more).

II. To describe the mutational load and targeted sequencing of well-known oncogenes and
changes in these markers of patients at up to three time points (baseline, cycle 2, and
progression), and across strata to describe associations with survival outcomes.

III. To describe the presence of germline mutations, and across strata to evaluate
association with outcome.

IV. Within strata, to describe patient risk category as defined by the biodesix protein
signature and change over time at up to three time points (baseline, cycle 2, progression),
and across strata to evaluate associations with outcomes.

V. Within strata, to evaluate the association of PD-L1 expression (positive versus negative)
with response and survival outcomes, and within strata, to characterize baseline PD-L1
prevalence.

VI. To collect specimens for banking for use in future correlative biomarker research
studies.

OUTLINE:

Patients receive nivolumab intravenously (IV) over 30 minutes on days 1, 15, and 29 and
ipilimumab IV over 60 minutes on day 1. Courses repeat every 42 days in the absence of
disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 10 years from registration.

Inclusion Criteria:

- Patients are eligible under ONE of the following criteria:

- Patients must have histologically confirmed rare cancer and must be able to
submit specimens; NOTE: Subsequent to site's Institutional Review Board (IRB)
approval of revision 3, patients are NOT required to participate in EAY131
"National Cancer Institute (NCI)-Molecular Analysis for Therapy Choice (MATCH)"
to register to this study

- FOR PATIENTS ENROLLED IN EAY131 "NCI-MATCH" PRIOR TO EAY131 ADDENDUM 10 ONLY:
Patients must have histologically confirmed rare cancer that did not have a match
to a molecularly-guided therapy on EAY131 "NCI-MATCH" protocol or who are off
protocol treatment on EAY131, "NCI-MATCH" and have no further molecularly-matched
treatment recommendations per EAY131, "NCI-MATCH" or who are otherwise unable to
receive EAY131, "NCI-MATCH" therapy

- Patients that do not qualify for one of the histologic cohorts may be considered for
registration in the "Not Otherwise Categorized" Rare Tumors cohort with confirmation
of at least one of the study chairs via email

- Patients that are determined to have a rare cancer with unknown primary site are
eligible under cohort #32 (tumor of unknown primary [cancer of unknown primary; CuP]),
provided that there is histologic documentation of metastatic malignancy with no
discernible primary site identified from histopathologic review, physical exam and
associated cross-sectional imaging of the chest, abdomen, and pelvis

- Patients must have progressed following at least one line of standard systemic therapy
and there must not be other approved/standard therapy available that has been shown to
prolong overall survival (i.e. in a randomized trial against another standard
treatment or by comparison to historical controls); patients who cannot receive other
standard therapy that has been shown to prolonged survival due to medical issues will
be eligible, if other eligibility criteria are met; OR

- Patients for whose disease no standard treatment exists that has been shown to
prolong overall survival

- Patients must have a diagnostic quality computed tomography (CT) scan or magnetic
resonance imaging (MRI), performed within 28 days prior to registration, which
demonstrates measurable disease, as defined in RECIST v. 1.1; all disease must be
assessed and documented on the S1609 Baseline Tumor Assessment Form

- No other prior malignancy is allowed except for the following:

- Adequately managed stage I or II cancer from which the patient is currently in
complete remission

- Any other cancer from which the patient has been disease free for one year

- Adequately managed stage I or II follicular thyroid or prostate cancer is also
eligible, wherein patient is not required to be in complete remission

- Patients may have received prior anti-CTLA4 or other anti-PD-1/anti-PD-L1 therapy, not
both, provided that it is completed >= 4 weeks prior to registration

- Patients who had prior grade 3 or higher immune-related adverse event (e.g.
pneumonitis, hepatitis, colitis, endocrinopathy) with prior immunotherapy (e.g. cancer
vaccine, cytokine, etc.) are not eligible

- Patients with clinically controlled thyroiditis or pituitary disorders on stable
replacement therapy are eligible

- Patients are not eligible if they have had or are planned for solid organ transplant;
patients who have received allogeneic hematopoietic stem cell transplant are eligible
if:

- The transplant occurred at least 90 days prior to registration,

- Patient has no prior acute graft versus host disease (GVHD), and

- Within 48 hours of registration, patient demonstrates at least 90% engraftment,
defined as: absolute neutrophil count (ANC) >= 500 mcl, measured over 3
consecutive days or 1 day with an ANC >= 1,000 mcl, or platelets >= 50,000 mcl
measured, wherein the patient did not receive any platelet transfusions within 7
days prior to laboratory assessment

- Patients with autoimmune disease who are otherwise eligible must not have received
steroid and immunosuppressive therapy within 28 days prior to registration

- Patients with brain metastases or primary brain tumors must have completed treatment,
surgery or radiation therapy >= 28 days prior to registration and have stable disease
at time of registration; metastatic brain parenchymal disease must have been treated
and patient must be off steroids for 7 days prior to registration; patients must have
a CT or MRI scan of the brain to evaluate for central nervous system (CNS) disease
within 42 days prior to registration

- Patients must not currently be receiving any other investigational agents or any other
systemic anti-cancer therapy (including radiation, excluding RANKL inhibitors and
bisphosphonates); in event patient recently received any other systemic anti-cancer
therapy, patient must be off therapy at least 7 days prior to registration and any
therapy-induced toxicity must have recovered to =< grade 1, except alopecia and =<
grade 2 neuropathy which are allowed; any planned radiation therapy must be completed
before enrollment onto S1609

- Patients must not have prior history of allergy or known hypersensitivity to nivolumab
or ipilimumab

- Patients must have a Zubrod performance status of 0-2

- Within 28 days prior to registration: ANC >= 1,000/mcL

- Within 28 days prior to registration: Platelets >= 75,000/mcL

- Within 28 days prior to registration: Hemoglobin >= 8 g/dL

- Within 28 days prior to registration: Total bilirubin =< 2.0 x institutional upper
limit of normal (IULN) or for documented/suspected Gilbert's disease, total bilirubin
=< 3.0 x IULN

- Within 28 days prior to registration: Aspartate aminotransferase (AST) and alanine
aminotransferase (ALT) both =< 3 x IULN

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

- Within 28 days prior to registration: Creatinine clearance (CrCl) >= 50 mL/min., as
estimated by the Cockcroft and Gault formula; estimated creatinine clearance is based
on actual body weight

- Patients must have adequate thyroid function, as evidenced by either
thyroid-stimulating hormone (TSH) or, free thyroxine (T4) serum tests demonstrating
values within the normal range, within 28 days prior to registration; Note: TSH, with
reflex T4 is allowable if per institutional standard; otherwise, both TSH and free-T4
must be obtained

- Patients must have adequate adrenal axis function, as evidenced by adrenocorticotropic
hormone (ACTH) values within the institutional normal ranges OR cortisol levels within
institutional normal ranges (ante meridiem [AM] cortisol preferred), within 28 days
prior to registration

- Females of childbearing potential must have negative serum or urine pregnancy test 7
days prior to registration and agree to use birth control throughout study and for 23
weeks after completion of protocol therapy; patients must not be pregnant or nursing;
women/men of reproductive potential must have agreed to use an effective contraceptive
method; 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; however, if at any point a previously celibate patient chooses to become
heterosexually active during the time period for use of contraceptive measures
outlined in the protocol, he/she is responsible for beginning contraceptive measures

- Men of reproductive potential must have agreed to use birth control throughout the
study and for 31 weeks after completion of protocol therapy; in addition to routine
contraceptive methods, "effective contraception" also includes heterosexual celibacy
and surgery intended to prevent pregnancy (vasectomy); however, if at any point a
previously celibate patient chooses to become heterosexually active during the time
period for use of contraceptive measures outlined in the protocol, he is responsible
for beginning contraceptive measures

- Patients must not have known active hepatitis B virus (HBV) or hepatitis virus (HCV)
infection at time of registration; patients with HBV or HCV that have an undetectable
viral load, or in the opinion of the treating investigator is well-controlled, are
eligible

- Patients who are known to be human immunodeficiency virus (HIV)-positive at
registration are eligible at the time of registration:

1. Cluster of differentiation (CD)4+ cell count greater or equal to 250 cells/mm^3

2. If patient is on antiretroviral therapy, there must be minimal interactions or
overlapping toxicity of the antiretroviral therapy with the experimental cancer
treatment; once daily combinations that use pharmacologic boosters may not be
used

3. No history of non-malignancy acquired immunodeficiency syndrome (AIDS)-defining
conditions other than historical low CD4+ cell counts

- Patients must not have active autoimmune disease that has required systemic treatment
in past 2 years (i.e., with use of disease modifying agents, immunosuppressive drugs,
or corticosteroids with doses higher than prednisone 10mg or equivalent); replacement
therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy
for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic
treatment; autoimmune diseases include but are not limited to autoimmune hepatitis,
inflammatory bowel disease (including ulcerative colitis and Chron's disease), as well
as symptomatic disease (e.g. rheumatoid arthritis, systemic progressive sclerosis
[scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener's
Granulomatosis]); CNS or motor neuropathy considered of autoimmune origin (e.g.,
Guillain-Barre syndrome and myasthenia gravis, multiple sclerosis or
glomerulonephritis); vitiligo, alopecia, hypothyroidism on stable doses of thyroid
replacement therapy, psoriasis not requiring systemic therapy within the past 2 years
is permitted; short-term steroid premedication for contrast allergy is permitted

- Patients must not have any uncontrolled intercurrent illness including (not limited
to): symptomatic congestive heart failure (CHF) (New York Heart Association [NYHA]
III/IV), unstable angina pectoris or coronary angioplasty, or stenting within 24 weeks
prior to registration, unstable cardiac arrhythmia (ongoing cardiac dysrhythmias of
NCI Common Terminology Criteria for Adverse Events [CTCAE] version [v] 4 grade >= 2),
known psychiatric illness that would limit study compliance, intra-cardiac
defibrillators, known cardiac metastases, or abnormal cardiac valve morphology (>=
grade 3)

- Note: Patients with history of CHF or patients who are deemed at risk because of
underlying cardiovascular disease or exposure to cardiotoxic drugs should have an
electrocardiogram (EKG) and echocardiogram (ECHO), as clinically indicated, at
baseline and at the start of each cycle; patients who have evidence at baseline
(or subsequently) of CHF, myocardial infarction (MI), cardiomyopathy, or myositis
cardiac evaluation (NYHA I/II) should have additional consult by a cardiologist,
including review of EKG, creatine phosphokinase (CPK), troponin, echocardiogram,
as clinically indicated

- Patients must have amylase or lipase within =< 1.5 x IULN without symptoms of
pancreatitis at registration, within 28 days prior to registration

- Patients must not have symptomatic interstitial lung disease or pneumonitis

- Patients must have fully recovered from any adverse effects of major surgery (to =<
grade 1) at least 14 days prior to registration
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666 Elm Street
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802-656-8990
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3500 Gaston Avenue
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1.800.422.9567
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2500 N State St
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Phone: 601-815-6700
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Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
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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
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(702) 383-2000
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University Medical Center of Southern Nevada University Medical Center is dedicated to providing the highest...
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529 West Markham Street
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Principal Investigator: Jeffrey L. Berenberg
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Principal Investigator: Vi K. Chiu
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Albuquerque, New Mexico 87109
Principal Investigator: Vi K. Chiu
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Ames, Iowa 50010
Principal Investigator: Debra M. Prow
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Principal Investigator: Gary E. Goodman
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Anchorage, Alaska 99504
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 99508
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
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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5301 McAuley Drive
Ann Arbor, Michigan 48197
734-712-3456
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Phone: 734-712-3671
Saint Joseph Mercy Hospital St. Joseph Mercy Ann Arbor Hospital is a 537-bed teaching hospital...
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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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Asheville, North Carolina 28803
Principal Investigator: Raymond Thertulien
Phone: 828-650-8037
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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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Ashland, WI
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1968 Peachtree Rd NW
Atlanta, Georgia 30309
(404) 605-5000
Principal Investigator: John W. McBroom
Phone: 404-425-7943
Piedmont Hospital For more than a century, Piedmont Healthcare has been a recognized leader in...
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Atlanta, Georgia 30322
Principal Investigator: Bradley C. Carthon
Phone: 404-778-1868
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Atlanta, Georgia 30342
Principal Investigator: Bradley C. Carthon
Phone: 888-823-5923
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550 Peachtree St NE
Atlanta, Georgia 30308
(404) 686-4411
Principal Investigator: Bradley C. Carthon
Phone: 888-946-7447
Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
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Auburn, California 95602
Principal Investigator: Ari D. Baron
Phone: 415-209-2686
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Auburn, California 95603
Principal Investigator: Ari D. Baron
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: Sarah L. Davis
Phone: 720-848-0650
University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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2000 Ogden Ave
Aurora, Illinois 60504
(630) 978-6200
Principal Investigator: James R. Egner
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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Avon, Indiana 46123
Principal Investigator: Kathy D. Miller
Phone: 317-278-5632
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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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Bakersfield, California 93301
Principal Investigator: Edward J. Kim
Phone: 661-323-4673
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Baldwin Park, California 91706
Principal Investigator: Han A. Koh
Phone: 800-398-3996
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Ballwin, Missouri 63011
Principal Investigator: Jay W. Carlson
Phone: 314-251-7058
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401 North Broadway
Baltimore, Maryland 21287
410-955-5000
Principal Investigator: Julie R. Brahmer
Phone: 410-955-8804
Johns Hopkins University-Sidney Kimmel Cancer Center The name Johns Hopkins has become synonymous with excellence...
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6701 N Charles St
Baltimore, Maryland 21204
(443) 849-2000
Principal Investigator: Mei Tang
Phone: 443-849-3706
Greater Baltimore Medical Center The 255-bed medical center (acute and sub-acute care) is located on...
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489 State St
Bangor, Maine 04401
(207) 973-7000
Principal Investigator: Thomas H. Openshaw
Phone: 207-973-4274
Eastern Maine Medical Center Located in Bangor, Eastern Maine Medical Center (EMMC) serves communities throughout...
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4305 New Shepherdsville Road
Bardstown, Kentucky 40004
Principal Investigator: Richard L. Deming
Phone: 308-398-6518
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Baton Rouge, Louisiana 70809
Principal Investigator: Robert A. Ramirez
Phone: 225-761-5346
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Baton Rouge, Louisiana 70806
Principal Investigator: Hana F. Safah
Phone: 225-381-6451
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Baton Rouge, Louisiana 70806
Principal Investigator: Hana F. Safah
Phone: 225-767-0822
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Baton Rouge, Louisiana 70816
Principal Investigator: Robert A. Ramirez
Phone: 225-761-5346
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Baton Rouge, Louisiana 70836
Principal Investigator: Robert A. Ramirez
Phone: 504-703-8712
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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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Beaver, Pennsylvania 15009
Principal Investigator: Melissa A. Burgess
Phone: 412-692-2001
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3535 Pentagon Boulevard
Beavercreek, Ohio 45431
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
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Bellevue, Washington 98004
Principal Investigator: John A. Keech
Phone: 425-688-5407
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Bellflower, California 90706
Principal Investigator: Han A. Koh
Phone: 800-398-3996
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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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Bemidji, Minnesota 56601
Principal Investigator: Preston D. Steen
Phone: 218-333-5000
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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: Ari D. Baron
Phone: 415-209-2686
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Berlin, Vermont 05602
Principal Investigator: Hibba Tul Rehman
Phone: 802-225-5400
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9000 Rockville Pike
Bethesda, Maryland 20892
301-496-2563
Principal Investigator: A P. Chen
Phone: 800-411-1222
National Institutes of Health Clinical Center The National Institutes of Health (NIH) Clinical Center in...
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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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Birmingham, Alabama 35233
Principal Investigator: Carla I. Falkson
Phone: 205-934-0220
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