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

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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.


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
Peoria, Illinois 61615
Principal Investigator: Francois J. Geoffroy
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Peoria, IL
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201 East Huron Street
Chicago, Illinois 60611
Principal Investigator: Devalingam Mahalingam
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Chicago, IL
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425 University Blvd.
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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Indianapolis, IN
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1871 SE Tiffany Ave # 100
Port Saint Lucie, Florida 34952
Principal Investigator: Heather Yeckes-Rodin
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Port Saint Lucie, FL
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3181 Southwest Sam Jackson Park Road
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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Portland, OR
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Athens, Georgia 30607
Principal Investigator: Petros Nikolinakos
Phone: 706-353-2990
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Athens, GA
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Baltimore, Maryland 21237
Principal Investigator: Suman B. Rao
Phone: 443-777-7364
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Baltimore, MD
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Billings, MT
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Chicago, Illinois 60612
Principal Investigator: Oana Danciu
Phone: 312-355-5112
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Chicago, IL
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Fairway, Kansas 66205
Principal Investigator: Stephen K Williamson
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Fairway, KS
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Houston, Texas 77024
Principal Investigator: Julio Peguero
Phone: 713-600-0992
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Houston, TX
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1515 Holcombe Blvd
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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Houston, TX
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Iowa City, Iowa 52242
Principal Investigator: Mohammed Milhem
Phone: 319-356-2324
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Iowa City, IA
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Kennewick, Washington 99336
Principal Investigator: Ying Zhuo
Phone: 509-783-0144
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Kennewick, WA
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Lacey, Washington 98503
Principal Investigator: Xingwei Sui
Phone: 360-412-8958
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Lacey, WA
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Las Vegas, Nevada 89169
Principal Investigator: Fadi Braiteh
Phone: 702-952-3400
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Las Vegas, NV
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600 Highland Ave
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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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
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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Omaha, NE
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San Francisco, California 94120
Principal Investigator: Ari D. Baron
Phone: 415-600-3241
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San Francisco, CA
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