Lung-MAP: Nivolumab With or Without Ipilimumab as Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer and No Matching Biomarkers



Status:Recruiting
Conditions:Lung Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:9/2/2018
Start Date:December 18, 2015
End Date:April 1, 2022

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A Phase III Randomized Study of Nivolumab Plus Ipilimumab Versus Nivolumab for Previously Treated Patients With Stage IV Squamous Cell Lung Cancer and No Matching Biomarker (Lung-Map Sub-Study)

This randomized phase III trial compares nivolumab with ipilimumab and nivolumab alone in
treating patients with stage IV squamous cell lung cancer that has come back after previous
treatment. This is a "non-match" sub-study that includes all screened patients not eligible
for a biomarker-driven sub-study. Monoclonal antibodies, such as nivolumab and ipilimumab,
may be able to shrink tumors. It is not yet known whether nivolumab works better with or
without ipilimumab in treating patients with squamous cell lung cancer.

PRIMARY OBJECTIVES:

I. To compare overall survival (OS) in patients with advanced stage refractory squamous cell
carcinoma (SCCA) of the lung randomized to nivolumab plus ipilimumab versus nivolumab.

SECONDARY OBJECTIVES:

I. To compare investigator-assessed progression-free survival (IA-PFS) in patients with
advanced stage refractory SCCA of the lung randomized to nivolumab plus ipilimumab versus
nivolumab.

II. To compare the response rates (confirmed and unconfirmed, complete and partial) per
Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 among patients randomized to
receive nivolumab plus ipilimumab versus nivolumab.

III. To compare the response rates (confirmed only, complete and partial) per RECIST 1.1
among patients randomized to receive nivolumab plus ipilimumab versus nivolumab.

IV. To evaluate the frequency and severity of toxicities associated with nivolumab plus
ipilimumab versus nivolumab.

TRANSLATIONAL MEDICINE OBJECTIVES:

I. To evaluate if there is a differential treatment effect on OS, IA-PFS, and response by
tumor programmed death-ligand 1 (PD-L1) expression status.

II. To examine patient reported outcomes by treatment arm.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive nivolumab intravenously (IV) over 30 minutes on day 1 and ipilimumab
IV over 60 minutes on day 1 of every third course (every 42 days). Courses repeat every 14
days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive nivolumab IV over 30 minutes on day 1. Courses repeat every 14 days
in the absence of disease progression or unacceptable toxicity.

After completion of study treatment but prior to disease progression, patients are followed
up every 3 months for 1 year and then every 6 months for up to 3 years. After disease
progression, patients are followed up every 6 months for 2 years and at end of year 3 after
sub-study registration.

Inclusion Criteria:

- Patients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON
ELIGIBILITY CRITERIA as specified in S1400: Phase II/III Biomarker-Driven Master
Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map)

- Patients must have been assigned to S1400I

- Patients must not have had prior treatment with an anti-programmed cell death (PD)-1,
anti-PD-L1, anti-PD-L2, anti-cytotoxic T-lymphocyte-associated protein (CTLA)-4
antibody, or any other antibody or drug specifically targeting T-cell costimulation or
immune checkpoint pathways

- Patients must not have an active, known, or suspected autoimmune disease; patients are
permitted to enroll if they have vitiligo, type I diabetes mellitus, hypothyroidism
only requiring hormone replacement, psoriasis not requiring systemic treatment, or
conditions not expected to recur in the absence of an external trigger

- Patients must not have any known allergy or reaction to any component of the nivolumab
and ipilimumab formulations

- Patients must not have received systemic treatment with corticosteroids (> 10 mg daily
prednisone or equivalent) or other immunosuppressive medications within 14 days prior
to sub-study 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 known positive test for hepatitis B virus surface antigen
(HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or
chronic infection; patients with a positive hepatitis C antibody with a negative viral
load are allowed

- Patients must not have known history of testing positive for human immunodeficiency
virus (HIV) or known acquired immunodeficiency syndrome (AIDS)

- Patients must not have interstitial lung disease that is symptomatic or disease that
may interfere with the detection or management of suspected drug-related pulmonary
toxicity

- Patients must also be offered participation in banking for future use of specimens

- Patients must have a lipase, amylase, TSH with reflex free T3/T4 performed within 7
days prior to sub-study registration

- Patients must not have any grade III/IV cardiac disease as defined by the New York
Heart Association Criteria (i.e., patients with cardiac disease resulting in marked
limitation of physical activity or resulting in inability to carry on any physical
activity without discomfort), unstable angina pectoris, and myocardial infarction
within 6 months, or serious uncontrolled cardiac arrhythmia

- Patients with a history of congestive heart failure (CHF) or at risk because of
underlying cardiovascular disease or exposure to cardiotoxic drug should have an
electrocardiogram (EKG) and echocardiogram performed to evaluate cardiac function
as clinically indicated

- Patients with evidence of congestive heart failure (CHF), myocardial infarction
(MI), cardiomyopathy, or myositis should have a cardiac evaluation including lab
tests and cardiology consultations as clinically indicated including EKG,
creatine phosphokinase (CPK), troponin, and echocardiogram

- Patients who can complete Patient Reported Outcomes (PRO) forms in English are
required to complete a pre-study S1400I Patient Reported Outcomes (PRO) Questionnaire
and a pre-study S1400I European Quality of Life Five Dimension (EQ-5D) Questionnaire
within 14 days prior to registration; NOTE: Patients enrolled to S1400I prior to
9/1/2016 are not eligible for the PRO study
We found this trial at
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Tulsa, Oklahoma 74146
Principal Investigator: Mohammad A. Razaq
Phone: 405-271-8777
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
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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
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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
(484) 884-2200
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
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Bremerton, Washington 98310
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666 Elm Street
Buffalo, New York 14263
(716) 845-2300
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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
802-656-8990
Principal Investigator: Edmund Folefac
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1300 Jefferson Park Avenue
Charlottesville, Virginia 22908
434-243-6784
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University of Virginia Cancer Center We are fortunate in having state of the art clinical...
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3500 Gaston Avenue
Dallas, Texas 75246
1.800.422.9567
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1500 E Duarte Rd
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1 Hurley Plaza
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4725 North Federal Highway
Fort Lauderdale, Florida 33308
(954) 771-8000
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3551 Roger Brooke Dr
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301 University Blvd
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
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200 North Park Street
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(269) 382-2500
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1800 West Charleston Boulevard
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503 494-8311
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401 College Street
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60 Crittenden Blvd # 70
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4502 Medical Drive
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1100 Fairview Avenue North
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825 Eastlake Ave E
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3900 W Avera Drive
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(605) 322-4700
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Avera Cancer Institute Avera, the health ministry of the Benedictine and Presentation Sisters, is a...
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601 South Sherman Street
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(509) 228-1000
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808 North 39th Avenue
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'Aiea, Hawaii 96701
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98-1079 Moanalua Road
'Aiea, Hawaii 96701
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2226 Liliha Street
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Aberdeen, South Dakota 57401
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Albuquerque, New Mexico 87109
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Anchorage, Alaska 99504
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Anchorage, Alaska 99508
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Anchorage, Alaska 99508
Principal Investigator: Gary E. Goodman
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Anchorage, Alaska 99508
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Anchorage, Alaska 99508
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Anchorage, Alaska 99508
Principal Investigator: Gary E. Goodman
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Anchorage, Alaska 99508
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Anchorage, Alaska 99508
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2000 E Greenville St
Anderson, South Carolina 29621
(864) 512-4640
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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
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
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Antigo, Wisconsin 54409
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Antioch, California 94531
Principal Investigator: Louis Fehrenbacher
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364 White Oak St
Asheboro, North Carolina 27203
(336) 625-5151
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Randolph Hospital Since 1932, Randolph Hospital has been fortunate to employ dedicated and loyal personnel...
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Asheville, North Carolina 28801
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Asheville, North Carolina 28801
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Asheville, North Carolina 28803
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Ashland, Kentucky 41101
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1625 Maple Lane
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550 Peachtree St NE
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(404) 686-4411
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Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
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1000 Johnson Ferry Rd NE
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Auburn, California 95603
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Augusta, Georgia 30912
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1501 S Potomac St
Aurora, Colorado 80012
(303) 695-2600
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12605 East 16th Avenue
Aurora, Colorado 80045
720-848-0000
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2000 Ogden Ave
Aurora, Illinois 60504
(630) 978-6200
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3325 Pocahontas Road
Baker City, Oregon 97814
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Baltimore, Maryland 21229
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Baltimore, Maryland 21237
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Phone: 301-548-5743
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Baltimore, MD
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22 South Greene Street
Baltimore, Maryland 21201
410-328-7904
Principal Investigator: Dan P. Zandberg
Phone: 800-888-8823
University of Maryland Greenebaum Cancer Center The University of Maryland Marlene and Stewart Greenebaum Cancer...
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Baltimore, MD
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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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Baltimore, MD
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2401 W Belvedere Ave
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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Baltimore, MD
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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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Baltimore, MD
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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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Bangor, ME
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