Study of Pegilodecakin (LY3500518) With Nivolumab Compared to Nivolumab Alone Second-line Tx in Participants With Metastatic Non-Small Cell Lung Cancer
| Status: | Active, not recruiting | 
|---|---|
| Conditions: | Lung Cancer, Lung Cancer, Cancer | 
| Therapuetic Areas: | Oncology | 
| Healthy: | No | 
| Age Range: | 18 - Any | 
| Updated: | 4/5/2019 | 
| Start Date: | March 22, 2018 | 
| End Date: | March 25, 2022 | 
A Randomized Phase 2 Trial of AM0010 in Combination With Nivolumab vs. Nivolumab Alone as Second-Line Therapy in Subjects With Stage IV / Metastatic Wild Type Non-Small Cell Lung Cancer and Low Tumor Expression of PD-L1
To compare the efficacy of pegilodecakin in combination with nivolumab versus nivolumab alone
in participants with metastatic non-small cell lung cancer as measured by objective response
rate.
			in participants with metastatic non-small cell lung cancer as measured by objective response
rate.
This is an open-label, multi-center, randomized, Phase 2 study designed to compare the
efficacy and safety of pegilodecakin in combination with nivolumab versus nivolumab alone in
participants with stage IV / metastatic wild type non-small cell lung cancer and tumors with
low tumor expression of PD-L1 (0-49%).
efficacy and safety of pegilodecakin in combination with nivolumab versus nivolumab alone in
participants with stage IV / metastatic wild type non-small cell lung cancer and tumors with
low tumor expression of PD-L1 (0-49%).
Inclusion Criteria:
1. Participants must have histologically or cytologically confirmed WT NSCLC that is
stage IV / metastatic or recurrent
2. Participants must have received at least one prior systemic therapy that was not an
anti-PD-1, anti-PD-L1 and/or anti-CTLA-4 treatment for the advanced stage of the
disease
3. Participants with tumor tissue low expression of PD-L1 as defined by Tumor Proportion
Score (TPS) 0% - 49%
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
5. Participants with measurable disease by spiral computed tomography (CT) or magnetic
resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumor (RECIST) v.1.1
criteria
6. Participants that have completed prior radiotherapy or radiosurgery at least 2 weeks
prior to randomization
Exclusion Criteria:
1. Participants with active central nervous system (CNS) metastases or carcinomatous
meningitis
2. Participants with any serious or uncontrolled medical disorder or active infection
with the hepatitis virus or the human immunodeficiency virus (HIV)
3. Participants with Grade 1 (NCI-CTCAE v.4.03) toxicities attributed to prior
anti-cancer therapy (other than alopecia and fatigue) prior to randomization
4. Participants that have received nivolumab
5. Participants that have received therapy with anti-tumor vaccines or other
immuno-stimulatory antitumor agents
6. Participants with a history of severe hypersensitivity reactions to monoclonal
antibodies
7. Participants that have received therapy with anti-PD-1, anti-PD-L1, anti-PD-L-2,
anti-CD-137, and/or anti CTLA-4 antibodies
8. Participants receiving any investigational agent within 28 days of first
administration of trial treatment
9. Pregnant or lactating women
We found this trial at
    73
    sites
	
								Jacksonville, North Carolina 28546			
	
			
					Principal Investigator: Nagesh Jayaram, MD
			
						
										Phone: 910-353-0824
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									3900 W Avera Drive 
Sioux Falls, South Dakota 57108
	
			Sioux Falls, South Dakota 57108
(605) 322-4700 
							 
					Principal Investigator: Mark Huber, MD
			
						
										Phone: 605-322-3018
					
		Avera Cancer Institute Avera, the health ministry of the Benedictine and Presentation Sisters, is a...  
  
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								Abilene, Texas 79606			
	
			
					Principal Investigator: Anton Melnyk, MD
			
						
										Phone: 325-692-0188
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								Amarillo, Texas 79106			
	
			
					Principal Investigator: Leonardo Forero, MD
			
						
										Phone: 806-358-8654
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								Arlington, Texas 76014			
	
			
					Principal Investigator: Scott Fleischauer, MD
			
						
										Phone: 817-467-6092
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								Athens, Georgia 30607			
	
			
					Principal Investigator: Petros Nikolinakos, MD
			
						
										Phone: 706-353-2990
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									9000 Franklin Square Drive
Baltimore, Maryland 21237
	
			
					Baltimore, Maryland 21237
Principal Investigator: Suman Rao, MD
			
						
										Phone: 443-777-8876
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								Beaumont, Texas 77702			
	
			
					Principal Investigator: Scott McKenney, MD
			
						
										Phone: 409-899-7180
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								Beverly Hills, California 90211			
	
			
					Principal Investigator: David Berz, MD
			
						
										Phone: 310-432-8934
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								Blacksburg, Virginia 24060			
	
			
					Principal Investigator: Jerome Goldschmidt, MD
			
						
										Phone: 540-381-5291
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								Canton, Ohio 44718			
	
			
					Principal Investigator: Nashat Y Gabrail, MD
			
						
										Phone: 330-492-3345
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								Charleston, South Carolina 29403			
	
			
					Principal Investigator: Gene Saylors, MD
			
						
										Phone: 843-577-6957
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									2139 Auburn Ave
Cincinnati, Ohio 45219
	
			Cincinnati, Ohio 45219
(513) 585-2000
							 
					Principal Investigator: Manish Bhandari, MD
			
						
										Phone: 513-585-1777
					
		The Christ Hospital For more than 120 years, The Christ Hospital has been a leader...  
  
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									1400 E Boulder St
Colorado Springs, Colorado 80909
	
			
					Colorado Springs, Colorado 80909
Principal Investigator: Robert Hoyer, MD
			
						
										Phone: 719-365-9645
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								Columbus, Georgia 31904			
	
			
					Principal Investigator: Andrew Pippas, MD
			
						
										Phone: 706-478-7968
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								Dallas, Texas 75231			
	
			
					Principal Investigator: Kristi McIntyre, MD
			
						
										Phone: 214-265-2080
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								Dallas, Texas 75246			
	
			
					Principal Investigator: Kartik Konduri, MD
			
						
										Phone: 214-370-1000
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								Dallas, Texas 75203			
	
			
					Principal Investigator: Inna Shmerlin, MD
			
						
										Phone: 214-943-9911
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								Denver, Colorado 80205			
	
			
					Principal Investigator: Jennifer Eisenstein, MD
			
						
										Phone: 303-764-8523
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								Detroit, Michigan 48202			
	
			
					Principal Investigator: Igor Rybkin, MD
			
						
										Phone: 313-916-3721
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								Duluth, Minnesota 55805			
	
			
					Principal Investigator: Homam Alkaied, MD
			
						
										Phone: 218-249-2567
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								Eugene, Oregon 97401			
	
			
					Principal Investigator: Matthew Lonergan, MD
			
						
										Phone: 541-683-5001
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									8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
	
			Fairfax, Virginia 22031
(703) 280-5390
							 
					Principal Investigator: Timothy McCarthy, MD
			
						
										Phone: 703-280-5390
					
		Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...  
  
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								Flower Mound, Texas 75028			
	
			
					Principal Investigator: Vibha Thomas, MD
			
						
										Phone: 972-537-4100
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								Frederick, Maryland 21702			
	
			
					Principal Investigator: Elhamy Eskander, MD
			
						
										Phone: 240-566-4941
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									2720 North Harbor Boulevard
Fullerton, California 92835
	
			
					Fullerton, California 92835
Principal Investigator: William Lawler, MD
			
						
										Phone: 714-446-5642
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								Goshen, Indiana 46526			
	
			
					Principal Investigator: Ebenezer A Kio, MD
			
						
										Phone: 574-364-2439
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								Hattiesburg, Mississippi 39401			
	
			
					Principal Investigator: John Hrom, MD
			
						
										Phone: 601-288-2495
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									1 Salt Creek Lane
Hinsdale, Illinois 60521
	
			
					Hinsdale, Illinois 60521
Principal Investigator: Donald Sweet, MD
			
						
										Phone: 630-286-5543
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									1329 Lusitana Street
Honolulu, Hawaii 96813
	
			
					Honolulu, Hawaii 96813
Principal Investigator: David Tamura, MD
			
						
										Phone: 808-748-7834
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								Houston, Texas 77090			
	
			
					Principal Investigator: Anirudha Dasgupta, MD
			
						
										Phone: 877-870-2640
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								Houston, Texas 77024			
	
			
					Principal Investigator: Muffaddal Morkas, MD
			
						
										Phone: 713-467-1722
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								Huntsville, Alabama 35805			
	
			
					Principal Investigator: Paul Dang, MD
			
						
										Phone: 703-208-9212
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								Johnson City, New York 13790			
	
			
					Principal Investigator: Ronald Harris, MD
			
						
										Phone: 607-763-6850
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									1915 White Avenue
Knoxville, Tennessee 37916
	
			
					Knoxville, Tennessee 37916
Principal Investigator: Everett C Ribakove, MD
			
						
										Phone: 865-331-4985
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								Lake Success, New York 11042			
	
			
					Principal Investigator: Morton Coleman, MD
			
						
										Phone: 516-488-2918
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								Lansing, Michigan 48912			
	
			
					Principal Investigator: Gordon Srkalovic, MD
			
						
										Phone: 517-364-3712
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								Lexington, Kentucky 40503			
	
			
					Principal Investigator: Firas Badin, MD
			
						
										Phone: 859-260-6406
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								Lincoln, Nebraska 68506			
	
			
					Principal Investigator: Eric Avery, MD
			
						
										Phone: 402-484-4907
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								Lone Tree, Colorado 80124			
	
			
					Principal Investigator: Robert Jotte, MD
			
						
										Phone: 303-925-0700
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								Los Angeles, California 90017			
	
			
					Principal Investigator: Lasika Seneviratne, MD
			
						
										Phone: 213-977-1214
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								Louisville, Kentucky 40207			
	
			
					Principal Investigator: John Hamm, MD
			
						
										Phone: 319-272-2388
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								Lubbock, Texas 79410			
	
			
					Principal Investigator: Isaac Tafur, MD
			
						
										Phone: 806-725-8068
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									5236 West University Drive
McKinney, Texas 75071
	
			
					McKinney, Texas 75071
Principal Investigator: Monte Jones, MD
			
						
										Phone: 972-542-8609
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								Midland, Texas 79701			
	
			
					Principal Investigator: David Watkins, MD
			
						
										Phone: 432-687-1949
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									120 Mineola Boulevard
Mineola, New York 11501
	
			
					Mineola, New York 11501
Principal Investigator: Jeffrey Schneider, MD
			
						
										Phone: 516-663-3115
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								Minneapolis, Minnesota 55405			
	
			
					Principal Investigator: Timothy Larson, MD
			
						
										Phone: 612-884-6300
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								Morristown, New Jersey 07960			
	
			
					Principal Investigator: Missak Haigentz, MD
			
						
										Phone: 973-660-3157
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								Omaha, Nebraska 68130			
	
			
					Principal Investigator: Ralph Hauke, MD
			
						
										Phone: 402-691-6971
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								Paramus, New Jersey 07652			
	
			
					Principal Investigator: Eli Kirshner, MD
			
						
										Phone: 201-634-5791
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								Paris, Texas 75460			
	
			
					Principal Investigator: Sucharu Prakash, MD
			
						
										Phone: 903-785-0031
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								Pembroke Pines, Florida 33028			
	
			
					Principal Investigator: Luis Raez, MD
			
						
										Phone: 954-844-9132
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								Redlands, California 92373			
	
			
					Principal Investigator: Emad Ibrahim, MD
			
						
										Phone: 909-478-7973
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								Rockville, Maryland 20850			
	
			
					Principal Investigator: Nicholas Farrell, MD
			
						
										Phone: 301-424-6231
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								Sacramento, California 95816			
	
			
					Principal Investigator: Deepti Behl, MD
			
						
										Phone: 916-454-6931
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									2130 Northeast Interstate 410 Loop
San Antonio, Texas 78217
	
			
					San Antonio, Texas 78217
Principal Investigator: Raul Portillo, MD
			
						
										Phone: 210-224-6531
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								Santa Rosa, California 95403			
	
			
					Principal Investigator: Ian Anderson, MD
			
						
										Phone: 707-521-3830
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								Skokie, Illinois 60076			
	
			
					Principal Investigator: Ira Oliff, MD
			
						
										Phone: 224-534-7580
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									101 Nicolls Rd
Stony Brook, New York 11794
	
			Stony Brook, New York 11794
(631) 444-4000
							 
					Principal Investigator: Roger Keresztes, MD
			
						
										Phone: 631-638-0837
					
		Stony Brook University Medical Center Stony Brook Medicine expresses our shared mission of research, clinical...  
  
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								Tacoma, Washington 98405			
	
			
					Principal Investigator: Nehal Masood, MD
			
						
										Phone: 253-403-3321
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								Tallahassee, Florida 32308			
	
			
					Principal Investigator: Karen Russell, MD
			
						
										Phone: 850-431-0673
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								Tempe, Arizona 85284			
	
			
					Principal Investigator: Abhimanyu Ghose, MD
			
						
										Phone: 480-256-1664
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									2801 W. Bancroft
Toledo, Ohio 43606
	
			Toledo, Ohio 43606
419.530.4636
							 
					Principal Investigator: John J Nemunaitis, MD
			
						
										Phone: 419-383-6962
					
		University of Toledo The University of Toledo is one of 14 state universities in Ohio....  
  
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								Toledo, Ohio 43623			
	
			
					Principal Investigator: Rex Mowat, MD
			
						
										Phone: 419-214-4236
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								Tyler, Texas 75702			
	
			
					Principal Investigator: Matei Socoteanu, MD
			
						
										Phone: 903-579-9800
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								Vancouver, Washington 98684			
	
			
					Principal Investigator: David Smith, MD
			
						
										Phone: 360-449-6521
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								Waco, Texas 76712			
	
			
					Principal Investigator: Carlos Encarnacion, MD
			
						
										Phone: 254-399-0741
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								Waterloo, Iowa 50702			
	
			
					Principal Investigator: Mohammed Masri, MD
			
						
										Phone: 319-272-2388
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								Waukesha, Wisconsin 53188			
	
			
					Principal Investigator: Timothy Wassenaar, MD
			
						
										Phone: 262-928-5539
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								Weslaco, Texas 78596			
	
			
					Principal Investigator: Habib Ghaddar, MD
			
						
										Phone: 956-969-0021
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								Whittier, California 90603			
	
			
					Principal Investigator: Merrill K Shum, M.D.
			
						
										Phone: 562-693-4477
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								Wichita Falls, Texas 76310			
	
			
					Principal Investigator: Brian Ulrich, MD
			
						
										Phone: 940-691-8271
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								Winston-Salem, North Carolina 27103			
	
			
					Principal Investigator: Franklin Chen, MD
			
						
										Phone: 336-718-8335
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