A Study Of PF-05082566 As A Single Agent And In Combination With Rituximab



Status:Completed
Conditions:Lung Cancer, Skin Cancer, Cancer, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/23/2019
Start Date:June 21, 2011
End Date:February 20, 2019

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A PHASE 1 STUDY OF PF-05082566 AS A SINGLE AGENT IN PATIENTS WITH ADVANCED CANCER, AND IN COMBINATION WITH RITUXIMAB IN PATIENTS WITH NON-HODGKIN'S LYMPHOMA (NHL)

A study of PF-05082566, a 4-1BB agonist monoclonal antibody (mAb), in patients with solid
tumors or b-cell lymphomas, and in combination with rituximab in patients with CD20 positive
Non-Hodgkin's Lymphoma (NHL).


Inclusion Criteria

- Portion A: Histological or cytological diagnosis of advanced/metastatic solid tumor
malignancy or B cell lymphoma, for which no curative therapy is available. Portion A
expansion includes patients who have documented disease progression on a checkpoint
inhibitor (anti CTLA 4, anti PD1/PD L1 antibodies) per RECIST criteria. Tumor types
include metastatic melanoma, renal cell carcinoma (RCC), non-small cell lung cancer
(NCSLC) and squamous cell carcinoma of the head and neck (SCCHN). Patients in the dose
expansion stage are required to provide archival or baseline (obtained during the
screening period) tumor biopsies.

- Portion B: Histological confirmed relapsed or refractory CD20 positive NHL for which
no curative therapy is available. Patients enrolled in the expansion cohort must have
archival tissue available, sampled within 6 months of study entry. The Expansion
cohort includes patients with FL or DLBCL with relapsed or refractory disease.

- Measurable disease with at least one extranodal tumor mass >1.0 cm in the greatest
transverse diameter (GTD) or in the case of malignant lymph nodes >1.5 cm in the GTD.

- ECOG performance status of ≤ 1.

- Adequate bone marrow function, for Portion A: absolute neutrophil count (ANC) ≥ 1.5 x
109/L, platelet count ≥100 x 109/L, hemoglobin >9.0 g/dL. For Portion B: ANC ≥ 1.0 x
109/L, platelet count ≥ 75 x 109/L, and hemoglobin ≥ 8.0 g/dL. In both cases, patients
must be transfusion independent at least 14 days prior to screening.

- Serum creatinine ≤ 2 x ULN or estimated creatinine clearance ≥ 50 ml/min.

- Total serum bilirubin ≤ 1.5 x ULN unless the patient has documented Gilbert syndrome
and AST and ALT ≤ 2.5 x ULN.

Exclusion Criteria

- Patients with known symptomatic brain metastases requiring steroids.

- Prior allogeneic hematopoietic stem cell transplant.

- Immunosuppressive regimens involving systemic corticosteroids within 14 days before
the first dose of study treatment.

- Therapeutic or experimental monoclonal antibodies within 28 day or prior radiation
therapy within 14 days of the first dose of study drug.

- Autoimmune disorders and other diseases that compromise or impair the immune system.

- Unstable or serious concurrent medical conditions in the previous 6 months.

- Prior therapy with any anti CD137 monoclonal antibody.
We found this trial at
39
sites
825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
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Atlanta, Georgia 30322
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Atlanta, Georgia 30322
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Atlanta, Georgia 30322
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550 Peachtree St NE
Atlanta, Georgia 30308
(404) 686-4411
Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
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Atlanta, GA
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Emory University Hospital As the largest health care system in Georgia and the only health...
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Boston, Massachusetts 02215
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Boston, MA
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Creve Coeur, Missouri 63141
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Duarte, California 91010
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Encinitas, California 92024
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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3855 Health Sciences Dr,
La Jolla, California 92093
(858) 822-6100
UC San Diego Moores Cancer Center Established in 1978, UC San Diego Moores Cancer Center...
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Los Angeles, California 90095
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Los Angeles, California 90095
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Melbourne, Victoria 3004
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Palo Alto, California 94304
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Saint Louis, Missouri 63110
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Saint Louis, Missouri 63129
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Peters, Missouri 63376
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San Antonio, TX
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San Diego, California 92103
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San Diego, California 92037
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San Diego, California 92037
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Santa Monica, California 90404
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300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
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300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
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910 Sycamore Avenue
Vista, California 92081
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3800 Reservoir Road Northwest
Washington, District of Columbia 20007
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Washington, District of Columbia 20007
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