Durvalumab and Tremelimumab in Treating Patients With Recurrent Stage IV Lung Cancer
Status: | Recruiting |
---|---|
Conditions: | Lung Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | Any |
Updated: | 12/14/2018 |
Start Date: | October 2, 2017 |
End Date: | April 1, 2022 |
A Phase II Study of MEDI4736 (Durvalumab) Plus Tremelimumab as Therapy for Patients With Previously Treated Anti-PD-1/PD-L1 Resistant Stage IV Squamous Cell Lung Cancer (Lung-Map Non-Match Sub-Study)
This phase II trial studies how well durvalumab and tremelimumab works in treating patients
with stage IV lung cancer that has come back after previous treatment. Monoclonal antibodies,
such as durvalumab and tremelimumab, may interfere with the ability of tumor cells to grow
and spread.
with stage IV lung cancer that has come back after previous treatment. Monoclonal antibodies,
such as durvalumab and tremelimumab, may interfere with the ability of tumor cells to grow
and spread.
PRIMARY OBJECTIVES:
I. To evaluate the objective response rate (confirmed and unconfirmed, complete and partial)
by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 among patients treated with
durvalumab (MEDI4736) plus tremelimumab.
SECONDARY OBJECTIVES:
I. To estimate the duration of response (DoR) among patients who achieve a complete response
(CR) or partial response (PR) (confirmed and unconfirmed) by RECIST 1.1.
II. To estimate the duration of response (DoR) per immune-related response criteria among
patients who achieve a complete response (CR) or partial response (PR) (confirmed and
unconfirmed) by RECIST 1.1.
III. To evaluate overall survival (OS) among patients treated with durvalumab (MEDI4736) plus
tremelimumab.
IV. To evaluate investigator-assessed progression-free survival (IA-PFS) among patients
treated with durvalumab (MEDI4736) plus tremelimumab.
V. To evaluate IA-PFS assessed by immune-related response criteria (irRC-IA-PFS) among
patients treated with durvalumab (MEDI4736) plus tremelimumab.
VI. To evaluate the frequency and severity of toxicities associated with durvalumab
(MEDI4736) plus tremelimumab.
TERTIARY OBJECTIVES:
I. To explore the association of potential predictive markers identified in S1400A, with
response and progression-free survival (PFS).
II. To explore the association of PD-L1 expression status with response and PFS.
III. To contribute to an ongoing serum and tumor bank in S1400.
OUTLINE:
Patients receive tremelimumab intravenously (IV) over 60 minutes on day 1 for courses 1-4 and
durvalumab IV over 60 minutes on day 1. Courses 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 at the end of year 3.
I. To evaluate the objective response rate (confirmed and unconfirmed, complete and partial)
by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 among patients treated with
durvalumab (MEDI4736) plus tremelimumab.
SECONDARY OBJECTIVES:
I. To estimate the duration of response (DoR) among patients who achieve a complete response
(CR) or partial response (PR) (confirmed and unconfirmed) by RECIST 1.1.
II. To estimate the duration of response (DoR) per immune-related response criteria among
patients who achieve a complete response (CR) or partial response (PR) (confirmed and
unconfirmed) by RECIST 1.1.
III. To evaluate overall survival (OS) among patients treated with durvalumab (MEDI4736) plus
tremelimumab.
IV. To evaluate investigator-assessed progression-free survival (IA-PFS) among patients
treated with durvalumab (MEDI4736) plus tremelimumab.
V. To evaluate IA-PFS assessed by immune-related response criteria (irRC-IA-PFS) among
patients treated with durvalumab (MEDI4736) plus tremelimumab.
VI. To evaluate the frequency and severity of toxicities associated with durvalumab
(MEDI4736) plus tremelimumab.
TERTIARY OBJECTIVES:
I. To explore the association of potential predictive markers identified in S1400A, with
response and progression-free survival (PFS).
II. To explore the association of PD-L1 expression status with response and PFS.
III. To contribute to an ongoing serum and tumor bank in S1400.
OUTLINE:
Patients receive tremelimumab intravenously (IV) over 60 minutes on day 1 for courses 1-4 and
durvalumab IV over 60 minutes on day 1. Courses 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 at the end of year 3.
Inclusion Criteria:
- Patients must have been assigned to S1400F
- Patients must have progressed during or after prior platinum-based chemotherapy;
patients whose only prior platinum-based chemotherapy regimen was for stage I-III
disease (i.e. patient has not received any platinum-based chemotherapy for stage IV or
recurrent disease), disease progression on platinum-based chemotherapy must have
occurred within one year from the last date that patient received that therapy;
patients must have experienced disease progression during or after prior anti-PD-1 or
anti-PD-L1 antibody monotherapy as their most recent line of treatment; prior
PD-1/PD-L1 combination therapy is not permitted
- Prior exposure to CTLA-4 inhibitors (ipilimumab and tremelimumab) is not permitted;
prior exposure to the following is allowed: attenuated vaccines, anti-EGFR agents, and
granulocyte-macrophage colony-stimulating factor (GM-CSF)
- Patients must not have received nitrosoureas or mitomycin-C within 42 days prior to
sub-study registration
- Patients must not have any prior documented autoimmune or inflammatory disease
(including inflammatory bowel disease, diverticulitis with the exception of
diverticulosis, celiac disease, irritable bowel disease; Wegner syndrome; Hashimoto
syndrome) within 3 years prior to sub-study registration; patients with vitiligo,
immune-mediated alopecia, Grave?s disease, or psoriasis requiring systemic treatment
within the past 2 years are not eligible; patients with hypothyroidism (e.g. post
Hashimoto syndrome) who are stable on hormone replacement therapy are eligible
- Patients must not have any history of primary immunodeficiency
- Patients must not have received any immunosuppressive medication within 28 days prior
to sub-study registration and must not be planning to receive these medications while
on protocol therapy; systemic corticosteroids must be stopped at least 24 hours prior
to sub-study registration; however, intranasal and inhaled corticosteroids are allowed
at any time before and during protocol therapy
- Patients must not have experienced a grade 3 or worse immune-related adverse event
(irAE) (except asymptomatic nonbullous/nonexfoliative rash) or any unresolved irAE
grade 2, nor have experienced a toxicity that led to permanent discontinuation of
prior anti-PD-1/PD-L1 immunotherapy
- Patients must not have any history of organ transplant that requires use of
immunosuppressives
- Patients must not have any known allergy or reaction to any component of the
durvalumab (MEDI4736) and/or tremelimumab formulation
- Patients must not have clinical signs or symptoms of active tuberculosis infection
- Patients must not have received a live attenuated vaccination within 28 days prior to
sub-study registration
- Patients must not have known human immunodeficiency virus (HIV), or a known positive
test for hepatitis B virus surface antigen (HBV sAg), or hepatitis C virus ribonucleic
acid (HCV antibody) indicating current acute or chronic infection; patients with a
positive hepatitis C antibody with a negative viral load are allowed
- Patients must have a thyroid-stimulating hormone (TSH) with reflex free T3/free T4 (if
TSH is out of normal range) and electrocardiogram (EKG) obtained within 7 days prior
to sub-study registration
- Patients must also be offered participation in banking and in the correlative studies
for collection and future use of specimens
We found this trial at
1020
sites
6435 Chippewa Street
Saint Louis, Missouri 63109
Saint Louis, Missouri 63109
(314) 353-1870
Principal Investigator: Jay W. Carlson
Phone: 888-221-4849
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
Albuquerque, New Mexico 87131
(505) 272-4946
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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
Augusta, Maine 04330
(207) 621-6100
Principal Investigator: Thomas H. Openshaw
Phone: 207-973-4274
Harold Alfond Center for Cancer Care MaineGeneral's Harold Alfond Center for Cancer Care (HACCC) is...
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2545 Schoenersville Rd
Bethlehem, Pennsylvania 18017
Bethlehem, Pennsylvania 18017
(484) 884-2200
Principal Investigator: Philip J. Stella
Phone: 208-367-7954
Lehigh Valley Hospital - Muhlenberg At Lehigh Valley Health Network, we continually go the extra...
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Bremerton, Washington 98310
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Phone: 501-622-2100
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666 Elm Street
Buffalo, New York 14263
Buffalo, New York 14263
(716) 845-2300
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Phone: 877-275-7724
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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1 South Prospect Street
Burlington, Vermont 05401
Burlington, Vermont 05401
802-656-8990
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Phone: 802-656-4101
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1300 Jefferson Park Avenue
Charlottesville, Virginia 22908
Charlottesville, Virginia 22908
434-243-6784
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1500 E Duarte Rd
Duarte, California 91010
Duarte, California 91010
(626) 256-4673
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1 Hurley Plaza
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Flint, Michigan 48503
(810) 262-9000
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4725 North Federal Highway
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Fort Lauderdale, Florida 33308
(954) 771-8000
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2500 N State St
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Jackson, Mississippi 39216
(601) 984-1000
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200 North Park Street
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Kalamazoo, Michigan 49007
(269) 382-2500
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Phone: 616-391-1230
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1800 West Charleston Boulevard
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Las Vegas, Nevada 89102
(702) 383-2000
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Phone: 805-474-9143
University Medical Center of Southern Nevada University Medical Center is dedicated to providing the highest...
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777 Hemlock Street
Macon, Georgia 31201
Macon, Georgia 31201
(478) 633-1000
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Phone: 478-633-1226
Medical Center of Central Georgia Navicent Health is a designated Level I Trauma Center and...
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4805 Northeast Glisan Street
Portland, Oregon 97213
Portland, Oregon 97213
(503) 215-1111
Principal Investigator: Gary E. Goodman
Phone: 907-212-6871
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
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Phone: 503-494-1080
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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401 College Street
Richmond, Virginia 23298
Richmond, Virginia 23298
(804) 828-0450
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Phone: 888-823-5923
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4502 Medical Drive
San Antonio, Texas 78284
San Antonio, Texas 78284
(210) 567-7000
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Phone: 877-469-5300
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Phone: 907-212-6871
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Seattle, Washington 98109
Seattle, Washington 98109
(206) 667-5000
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Phone: 800-422-6237
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825 Eastlake Ave E
Seattle, Washington 98109
Seattle, Washington 98109
(206) 288-7222
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Phone: 800-422-6237
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3900 W Avera Drive
Sioux Falls, South Dakota 57108
Sioux Falls, South Dakota 57108
(605) 322-4700
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Phone: 888-634-7268
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601 South Sherman Street
Spokane, Washington 99202
Spokane, Washington 99202
(509) 228-1000
Principal Investigator: Christina S. Baik
Phone: 800-422-6237
Cancer Care Northwest - Spokane South Cancer Care Northwest is the Inland Northwest’s premier cancer...
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808 North 39th Avenue
Yakima, Washington 98902
Yakima, Washington 98902
Principal Investigator: John A. Keech
Phone: 907-458-5380
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'Aiea, Hawaii 96701
Principal Investigator: Jeffrey L. Berenberg
Phone: 808-586-2979
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98-1079 Moanalua Road
'Aiea, Hawaii 96701
'Aiea, Hawaii 96701
Principal Investigator: Jeffrey L. Berenberg
Phone: 808-586-2979
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'Ewa Beach, Hawaii 96706
Principal Investigator: Jeffrey L. Berenberg
Phone: 808-586-2979
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Aberdeen, South Dakota 57401
Principal Investigator: Amy K. Krie
Phone: 888-634-7268
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Aberdeen, Washington 98520
Principal Investigator: Gary E. Goodman
Phone: 907-212-6871
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Albany, Georgia 31701
Principal Investigator: Sharad A. Ghamande
Phone: 706-721-1663
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Albuquerque, New Mexico 87102
Principal Investigator: Ian Rabinowitz
Phone: 505-925-0366
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Albuquerque, New Mexico 87109
Principal Investigator: Ian Rabinowitz
Phone: 505-925-0366
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Allentown, Pennsylvania 18103
Principal Investigator: Philip J. Stella
Phone: 208-367-7954
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Amarillo, Texas 79106
Principal Investigator: Anita Ravipati
Phone: 806-212-1985
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170 North 1100 East
American Fork, Utah 84003
American Fork, Utah 84003
Principal Investigator: Derrick S. Haslem
Phone: 801-408-1347
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Anaconda, Montana 59711
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
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Anaheim, California 92806
Principal Investigator: Han A. Koh
Phone: 626-564-3455
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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
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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2000 E Greenville St
Anderson, South Carolina 29621
Anderson, South Carolina 29621
(864) 512-4640
Principal Investigator: John E. Doster
Phone: 864-512-1000
AnMedical Health Cancer Center Cancer is the general term for a group of more than...
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5301 McAuley Drive
Ann Arbor, Michigan 48197
Ann Arbor, Michigan 48197
734-712-3456
Principal Investigator: Philip J. Stella
Phone: 208-367-7954
Saint Joseph Mercy Hospital St. Joseph Mercy Ann Arbor Hospital is a 537-bed teaching hospital...
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
800-865-1125
Principal Investigator: Gregory P. Kalemkerian
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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Antigo, Wisconsin 54409
Principal Investigator: Harish G. Ahuja
Phone: 877-405-6866
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Antioch, California 94531
Principal Investigator: Louis Fehrenbacher
Phone: 626-564-3455
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364 White Oak St
Asheboro, North Carolina 27203
Asheboro, North Carolina 27203
(336) 625-5151
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Asheville, North Carolina 28801
Principal Investigator: Christopher H. Chay
Phone: 828-213-4150
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Asheville, North Carolina 28801
Principal Investigator: Christopher H. Chay
Phone: 828-213-4150
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Asheville, North Carolina 28803
Principal Investigator: Raymond Thertulien
Phone: 828-213-4150
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Ashland, Kentucky 41101
Principal Investigator: David K. Goebel
Phone: 888-823-5923
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Athens, Georgia 30607
Principal Investigator: Sharad A. Ghamande
Phone: 706-721-1663
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550 Peachtree St NE
Atlanta, Georgia 30308
Atlanta, Georgia 30308
(404) 686-4411
Principal Investigator: Taofeek K. Owonikoko
Phone: 404-489-9164
Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
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Atlanta, Georgia 30322
Principal Investigator: Taofeek K. Owonikoko
Phone: 404-489-9164
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5665 Peachtree Dunwoody Rd NE
Atlanta, Georgia 30342
Atlanta, Georgia 30342
(678) 843-7001
Principal Investigator: Taofeek K. Owonikoko
Phone: 404-489-9164
Saint Joseph's Hospital of Atlanta Founded by the Sisters of Mercy in 1880, Saint Joseph
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1000 Johnson Ferry Rd NE
Atlanta, Georgia 30342
Atlanta, Georgia 30342
(404) 851-8000
Principal Investigator: Rodolfo E. Bordoni
Phone: 404-303-3355
Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
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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: 907-458-5380
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Augusta, Georgia 30912
Principal Investigator: Sharad A. Ghamande
Phone: 706-721-1663
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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
Aurora, Colorado 80045
720-848-0000
Principal Investigator: Mark R. Hancock
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
Aurora, Illinois 60504
(630) 978-6200
Principal Investigator: Yujie Zhao
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: Michael A. Schwartz
Phone: 305-674-2625
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Bainbridge Island, Washington 98110
Principal Investigator: John A. Keech
Phone: 907-458-5380
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3325 Pocahontas Road
Baker City, Oregon 97814
Baker City, Oregon 97814
Principal Investigator: Philip J. Stella
Phone: 208-367-7954
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Bakersfield, California 93301
Principal Investigator: David R. Gandara
Phone: 916-734-3089
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Baldwin Park, California 91706
Principal Investigator: Han A. Koh
Phone: 626-564-3455
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Ballwin, Missouri 63011
Principal Investigator: Jay W. Carlson
Phone: 888-221-4849
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22 South Greene Street
Baltimore, Maryland 21201
Baltimore, Maryland 21201
410-328-7904
Principal Investigator: Dan P. Zandberg
Phone: 800-888-8823
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Principal Investigator: Deepa S. Subramaniam
Phone: 202-444-2223
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Baltimore, Maryland 21229
Principal Investigator: Carole B. Miller
Phone: 410-368-2910
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Baltimore, Maryland 21237
Principal Investigator: Deepa S. Subramaniam
Phone: 202-444-2223
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Baltimore, Maryland 21244
Principal Investigator: Leon C. Hwang
Phone: 301-548-5743
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6701 N Charles St
Baltimore, Maryland 21204
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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2401 W Belvedere Ave
Baltimore, Maryland 21215
Baltimore, Maryland 21215
(410) 601-9000
Principal Investigator: Roberto F. Martinez
Phone: 410-601-6120
Sinai Hospital of Baltimore Sinai Hospital of Baltimore provides a broad array of high-quality, cost-effective...
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401 North Broadway
Baltimore, Maryland 21287
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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489 State St
Bangor, Maine 04401
Bangor, Maine 04401
(207) 973-7000
Principal Investigator: Thomas H. Openshaw
Phone: 207-973-4274
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4305 New Shepherdsville Road
Bardstown, Kentucky 40004
Bardstown, Kentucky 40004
Principal Investigator: Mehmet S. Copur
Phone: 501-622-2100
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Baton Rouge, Louisiana 70805
Principal Investigator: Augusto C. Ochoa
Phone: 504-568-2428
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Baton Rouge, Louisiana 70806
Principal Investigator: Hana F. Safah
Phone: 504-988-6121
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Baton Rouge, Louisiana 70806
Principal Investigator: Hana F. Safah
Phone: 504-988-6121
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Baton Rouge, Louisiana 70809
Principal Investigator: David S. Hanson
Phone: 225-215-1353
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Baton Rouge, Louisiana 70809
Principal Investigator: David S. Hanson
Phone: 225-215-1353
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Baton Rouge, Louisiana 70809
Principal Investigator: David S. Hanson
Phone: 225-215-1353
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Baton Rouge, Louisiana 70809
Principal Investigator: Marc R. Matrana
Phone: 504-842-3708
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265 Fremont St
Battle Creek, Michigan 49017
Battle Creek, Michigan 49017
(269) 245-8166
Principal Investigator: Kathleen J. Yost
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Beachwood, Ohio 44122
Principal Investigator: Afshin Dowlati
Phone: 800-641-2422
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Principal Investigator: Liza C. Villaruz
Phone: 412-647-8073
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Principal Investigator: Ashkan Bahrani
Phone: 443-643-3010
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Principal Investigator: John A. Keech
Phone: 907-458-5380
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Principal Investigator: Han A. Koh
Phone: 626-564-3455
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Principal Investigator: Gary E. Goodman
Phone: 907-212-6871
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800 Farson Street
Belpre, Ohio 45714
Belpre, Ohio 45714
(740) 401-0417
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Phone: 614-488-2745
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1300 Anne Street NW
Bemidji, Minnesota 56601
Bemidji, Minnesota 56601
(218) 751-5430
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Phone: 712-252-0088
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Bend, Oregon 97701
Principal Investigator: Gary E. Goodman
Phone: 907-212-6871
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Berkeley, California 94704
Principal Investigator: Ari D. Baron
Phone: 415-209-2686
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