PDR001 Plus LAG525 for Patients With Advanced Solid and Hematologic Malignancies
| Status: | Active, not recruiting | 
|---|---|
| Conditions: | Lung Cancer, Prostate Cancer, Ovarian Cancer, Cancer, Cancer, Cancer, Cancer, Brain Cancer, Lymphoma | 
| Therapuetic Areas: | Oncology | 
| Healthy: | No | 
| Age Range: | 18 - Any | 
| Updated: | 3/31/2019 | 
| Start Date: | January 24, 2018 | 
| End Date: | January 20, 2020 | 
Modular Phase 2 Study to Link Combination Immune-therapy to Patients With Advanced Solid and Hematologic Malignancies. Module 9: PDR001 Plus LAG525 for Patients With Advanced Solid and Hematologic Malignancies.
The purpose of this signal seeking study is to determine whether treatment with PDR001 and
LAG525 demonstrates sufficient efficacy in advanced malignancies to warrant further study.
			LAG525 demonstrates sufficient efficacy in advanced malignancies to warrant further study.
Inclusion Criteria:
Patients eligible for inclusion in this study have to meet all of the following criteria:
- Patient must have had at least one prior line of therapy for their disease and must
not be beyond 4th progression/relapse of disease (5 maximum prior lines).
- Patient has a pathology confirmed diagnosis of a solid tumor or lymphoma listed in the
section "condition". Patients must have measurable disease as per appropriate
guidelines (Solid Tumors by RECIST 1.1 and Diffuse Large B-cell Lymphoma by Revised
Response Criteria for Malignant Lymphoma - Cheson et al 2007).
- Expansion Cohorts only: Patient must have a site of disease amenable to biopsy, and be
a candidate for tumor biopsy according to the treating institution's guidelines.
Exceptions may be considered after discussion with the sponsor.
Exclusion Criteria:
Patients eligible for this study must not meet any of the following criteria:
- History of severe hypersensitivity reactions to other mAbs.
- Impaired cardiac function or clinically significant cardiac disease.
- Active, known or suspected autoimmune disease or a documented history of autoimmune
disease within three years prior to screening with a few exceptions as per protocol.
- Patients previously exposed to anti-PD-1/PD-L1 treatment who are adequately treated
for skin rash or with replacement therapy for endocrinopathies should not be excluded.
- Patient with second primary malignancy within < 3 years of first dose of study
treatment.
- Prior immunotherapy treatment with PD-1, PD-L1, CTLA-4, or LAG-3 antibodies.
Other protocol-defined inclusion/exclusion criteria may apply.
We found this trial at
    20
    sites
	
									3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
	
			Portland, Oregon 97239
503 494-8311 
							 
					
		Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...  
  
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									201 East Huron Street
Chicago, Illinois 60611
	
			
					Chicago, Illinois 60611
Principal Investigator: Devalingam Mahalingam
			
						
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									425 University Blvd.
Indianapolis, Indiana 46202
	
			Indianapolis, Indiana 46202
(317) 274-4591
							 
					Principal Investigator: Bert O'Neil
			
						
										Phone: 317-274-0920
					
		Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...  
  
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									1871 SE Tiffany Ave # 100
Port Saint Lucie, Florida 34952
	
			
					Port Saint Lucie, Florida 34952
Principal Investigator: Heather Yeckes-Rodin
			
						
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								Athens, Georgia 30607			
	
			
					Principal Investigator: Petros Nikolinakos
			
						
										Phone: 706-353-2990
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								Baltimore, Maryland 21237			
	
			
					Principal Investigator: Suman B. Rao
			
						
										Phone: 443-777-7364
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								Chicago, Illinois 60612			
	
			
					Principal Investigator: Oana Danciu
			
						
										Phone: 312-355-5112
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								Fairway, Kansas 66205			
	
			
					Principal Investigator: Stephen K Williamson
			
						
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								Houston, Texas 77024			
	
			
					Principal Investigator: Julio Peguero
			
						
										Phone: 713-600-0992
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									1515 Holcombe Blvd
Houston, Texas 77030
	
			Houston, Texas 77030
 713-792-2121 
							 
					Principal Investigator: Sarina Piha-Paul
			
						
								
		University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...  
  
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								Iowa City, Iowa 52242			
	
			
					Principal Investigator: Mohammed Milhem
			
						
										Phone: 319-356-2324
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								Kennewick, Washington 99336			
	
			
					Principal Investigator: Ying Zhuo
			
						
										Phone: 509-783-0144
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								Lacey, Washington 98503			
	
			
					Principal Investigator: Xingwei Sui
			
						
										Phone: 360-412-8958
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								Las Vegas, Nevada 89169			
	
			
					Principal Investigator: Fadi Braiteh
			
						
										Phone: 702-952-3400
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									600 Highland Ave
Madison, Wisconsin 53792
	
			Madison, Wisconsin 53792
(608) 263-6400
							 
					Principal Investigator: Nataliya Uboha
			
						
										Phone: 608-263-4900
					
		University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...  
  
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		Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...  
  
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								Omaha, Nebraska 68130			
	
			
					Principal Investigator: Stefano Tarantolo
			
						
										Phone: 402-691-6971
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								Peoria, Illinois 61615			
	
			
					Principal Investigator: Francois J. Geoffroy
			
						
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								San Francisco, California 94120			
	
			
					Principal Investigator: Ari D. Baron
			
						
										Phone: 415-600-3241
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