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

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
City of Hope Investigational Drug Services
Duarte, California, 91010 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-Hodgkin Lymphoma, Follicular Lymphoma, Large B-Cell Lymphoma, Non-Small-Cell Lung Carcinoma, Renal Cell Carcinoma, Squamous Cell of Head and Neck Carcinoma, 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.
Show details

- 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.

NCT01307267
Pfizer
Recruiting
A Study Of PF-05082566 As A Single Agent And In Combination With Rituximab

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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)
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).
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
  • 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
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
270
January 2020
November 2019   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Australia,   France,   Italy,   Japan,   United States
 
 
NCT01307267
B1641001
2011-002799-17 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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