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A Study Of PF-05082566 As A Single Agent And In Combination With Rituximab | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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)

NCT01307267•Pfizer

View on ClinicalTrials.gov

Summary

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).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (42)

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

Key Dates

Start Date

June 21, 2011

Primary Completion Date

February 20, 2019

Completion Date

February 20, 2019

Last Updated

March 17, 2020

Enrollment

190

ACTUAL participants

Conditions

Lymphoma, Non-HodgkinLymphoma, FollicularLymphoma, Large B-Cell, DiffuseCarcinoma, Non-Small-Cell LungCarcinoma, Renal CellCarcinoma, Squamous Cell of Head and NeckMalignant Melanoma

Interventions

PF-05082566

DRUG

rituximab

DRUG

PF-05082566

DRUG

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RECRUITINGPHASE1/PHASE2

CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory CD19/CD22-expressing B Cell Malignancies

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 17, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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