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 |
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.
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.
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
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Principal Investigator: Gary E. Goodman
Phone: 907-212-6871
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Principal Investigator: Gary E. Goodman
Phone: 907-212-6871
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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
![AnMedical Health Cancer Center](/wp-content/uploads/logos/anmedical-health-cancer-center.jpg)
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
![Saint Joseph Mercy Hospital](/wp-content/uploads/logos/saint-joseph-mercy-hospital.jpg)
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
![University of Michigan Comprehensive Cancer Center](/wp-content/uploads/logos/university-of-michigan-comprehensive-cancer-center.jpg)
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
![Randolph Hospital](/wp-content/uploads/logos/randolph-hospital.png)
Principal Investigator: Vinay K. Gudena
Phone: 336-832-0821
Randolph Hospital Since 1932, Randolph Hospital has been fortunate to employ dedicated and loyal personnel...
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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
![Emory University Hospital Midtown](/wp-content/uploads/logos/emory-university-hospital-midtown.png)
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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1000 Johnson Ferry Rd NE
Atlanta, Georgia 30342
Atlanta, Georgia 30342
(404) 851-8000
![Northside Hospital](/wp-content/uploads/logos/northside-hospital.jpg)
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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Medical Center of Aurora At The Medical Center of Aurora and Centennial Medical Plaza patients...
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12605 East 16th Avenue
Aurora, Colorado 80045
Aurora, Colorado 80045
720-848-0000
![University of Colorado Hospital](/wp-content/uploads/logos/university-of-colorado-hospital-site.jpg)
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
![Rush - Copley Medical Center](/wp-content/uploads/logos/rush---copley-medical-center.png)
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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Baltimore, Maryland 21218
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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22 South Greene Street
Baltimore, Maryland 21201
Baltimore, Maryland 21201
410-328-7904
![University of Maryland Greenebaum Cancer Center](/wp-content/uploads/logos/university-of-maryland-greenebaum-cancer-center.jpg)
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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6701 N Charles St
Baltimore, Maryland 21204
Baltimore, Maryland 21204
(443) 849-2000
![Greater Baltimore Medical Center](/wp-content/uploads/logos/greater-baltimore-medical-center.png)
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
![Sinai Hospital of Baltimore](/wp-content/uploads/logos/sinai-hospital-of-baltimore.jpg)
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
![Johns Hopkins University-Sidney Kimmel Cancer Center](/wp-content/uploads/logos/johns-hopkins-university-sidney-kimmel-cancer-center.png)
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
![Eastern Maine Medical Center](/wp-content/uploads/logos/eastern-maine-medical-center.png)
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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