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

Completed · Phase 1

Conditions studied: Lymphoma, Non-Hodgkin, Lymphoma, Follicular, Lymphoma, Large B-Cell, Diffuse, Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Carcinoma, Squamous Cell of Head and Neck, Malignant Melanoma

In brief

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).

Key facts

Study ID

NCT01307267

Run by

Pfizer

People needed

190

Starts

2011-06-21

Expected to finish

2019-02-20

Last updated by the study team

2020-03-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• City of Hope — Duarte, California, United States
• UC San Diego Moores Cancer Center-Investigational Drug Services — La Jolla, California, United States
• UC San Diego Medical Center-La Jolla (Jacobs Medical Center/Thornton Hospital) — La Jolla, California, United States
• UC San Diego Moores Cancer Center — La Jolla, California, United States
• Research Administration Office: Clinical Research Unit — Los Angeles, California, United States
• Ronald Reagan UCLA Medical Center, Drug Information Center — Los Angeles, California, United States
• UCLA Bowyer Clinic — Los Angeles, California, United States
• UCLA Hematology-Oncology Clinic — Los Angeles, California, United States
• Stanford University Medical Center — Palo Alto, California, United States
• Stanford University Medical Center — Palo Alto, California, United States
• UC San Diego Medical Center - Hillcrest — San Diego, California, United States
• Santa Monica UCLA Hematology & Oncology Clinic — Santa Monica, California, United States
• Stanford University Medical Center — Stanford, California, United States
• Georgetown University Medical Center Department of Pharmacy, Research — Washington D.C., District of Columbia, United States
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• Emory University Hospital Midtown — Atlanta, Georgia, United States
• Emory University Hospital — Atlanta, Georgia, United States
• The Emory Clinic, Building A — Atlanta, Georgia, United States
• The Emory Clinic — Atlanta, Georgia, United States
• Winship Cancer Institute — Atlanta, Georgia, United States
• Brigham and Woman's Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• University of Michigan Health System — Ann Arbor, Michigan, United States
• Siteman Cancer Center - St. Peters — City of Saint Peters, Missouri, United States
• Siteman Cancer Center-West County — Creve Coeur, Missouri, United States

Full record on ClinicalTrials.gov

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