Summary

for people ages 18 years and up (full criteria)
at UCLA UCSD
study started
estimated completion:

Description

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).

Official Title

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)

Keywords

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 Phase 1 Non-Hodgkin's Lymphoma Advanced malignancies Lymphoma Carcinoma Melanoma Carcinoma, Squamous Cell Head and Neck Neoplasms Rituximab Antibodies, Monoclonal Immunoglobulin G PF-05082566 Portion A Portion B

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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.

Locations

  • UCSD Medical Center-Encinitas
    Encinitas California 92024 United States
  • UC San Diego Moores Cancer Center-Investigational Drug Services
    La Jolla California 92037-0845 United States
  • UC San Diego Medical Center-La Jolla (Jacobs Medical Center/Thornton Hospital)
    La Jolla California 92037 United States
  • UC San Diego Moores Cancer Center
    La Jolla California 92093 United States
  • Research Administration Office: Clinical Research Unit
    Los Angeles California 90095 United States
  • Ronald Reagan UCLA Medical Center, Drug Information Center
    Los Angeles California 90095 United States
  • UCLA Bowyer Clinic
    Los Angeles California 90095 United States
  • UCLA Hematology-Oncology Clinic
    Los Angeles California 90095 United States
  • UCSD Perlman Medical Offices
    San Diego California 92037 United States
  • UC San Diego Medical Center - Hillcrest
    San Diego California 92103 United States
  • Santa Monica UCLA Hematology & Oncology Clinic
    Santa Monica California 90404 United States
  • UCSD Medical Center-Vista
    Vista California 92081 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
ID
NCT01307267
Phase
Phase 1
Study Type
Interventional
Last Updated