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

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NCT01307267

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Study Location
City of Hope
Duarte, California, 91010, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being 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
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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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 MelanomaA Study Of PF-05082566 As A Single Agent And In Combination With Rituximab
NCT01307267
  1. Duarte, California
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ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study Of PF-05082566 As A Single Agent And In Combination With Rituximab
Official Title  ICMJE 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)
Brief 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • 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
Intervention  ICMJE
  • Drug: PF-05082566
    Intravenous, Dose escalation, once per month
  • Drug: rituximab
    Intravenous, 375 mg/m2, once per week for 4 weeks
    Other Name: Rituxan, MabThera
  • Drug: PF-05082566
    IV, Dose escalation, once per month
Study Arms  ICMJE
  • Experimental: Portion A
    PF-05082566 single agent in patients with advanced cancer
    Intervention: Drug: PF-05082566
  • Experimental: Portion B
    PF-05082566 in combination with rituximab in patients with Non-Hodgkin's Lymphoma
    Interventions:
    • Drug: rituximab
    • Drug: PF-05082566
Publications * Segal NH, He AR, Doi T, Levy R, Bhatia S, Pishvaian MJ, Cesari R, Chen Y, Davis CB, Huang B, Thall AD, Gopal AK. Phase I Study of Single-Agent Utomilumab (PF-05082566), a 4-1BB/CD137 Agonist, in Patients with Advanced Cancer. Clin Cancer Res. 2018 Apr 15;24(8):1816-1823. doi: 10.1158/1078-0432.CCR-17-1922. Epub 2018 Mar 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 23, 2019)		190
Original Estimated Enrollment  ICMJE
 (submitted: February 28, 2011)		78
Actual Study Completion Date  ICMJE February 20, 2019
Actual Primary Completion Date February 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   France,   Italy,   Japan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01307267
Other Study ID Numbers  ICMJE B1641001
2011-002799-17 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP