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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01307267
First received: February 28, 2011
Last updated: July 7, 2016
Last verified: July 2016

February 28, 2011
July 7, 2016
June 2011
July 2017   (final data collection date for primary outcome measure)
  • Number of participants with Dose-limiting toxicities (DLT) [ Time Frame: First 2 cycles (56 days) of treatment ] [ Designated as safety issue: Yes ]
    Dose Limiting Toxicities (DLTs) of PF-05082566 as single agent
  • Number of participants with Dose-limiting toxicities (DLT) [ Time Frame: First 2 cycles (56 days) of treatment ] [ Designated as safety issue: Yes ]
    Dose Limiting Toxicities (DLTs) of PF-05082566 in combination with rituximab
Dose Limiting Toxicities (DLTs) of PF-05082566 as single agent and in combination with rituximab [ Time Frame: First 2 cycles of treatment ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01307267 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics (Tmax) of PF-05082566 and rituximab when given in combination [ Time Frame: Days -7, 0, 1, 3, 7, 1, 22, 29, 36, 43, 50, 57, 78, 85, 112 and 141, followed by every 28 days during the therapy up to 2 years. ] [ Designated as safety issue: Yes ]
    Pharmacokinetics of PF-05082566 and rituximab when given in combination
  • Pharmacokinetics (Tmax) of PF-05082566 as a single agent [ Time Frame: Days 1, 3, 8, 15, 22, 29, 31, 36, 43, 50, 57, 64, 71, 78, 85, 87, 112, followed by every 28 days during the therapy up to 2 years, then Days 28, 57 and 85 after the administration of the last dose. ] [ Designated as safety issue: Yes ]
    Pharmacokinetics of PF-05082566 and rituximab when given in combination
  • Presence of Anti-Drug Antibodies against PF-05082566 (Portion A) [ Time Frame: Days 1, 8, 15, 29, 36, 43, 57, 71, 127, 145 and every 28 days up to 2 years during the treatment and end of treatment ] [ Designated as safety issue: Yes ]
  • Presence of Anti-Drug Antibodies against PF-05082566 and rituximab (Portion B) [ Time Frame: Every 28 days during the treatment up to 2 years and at the end of treatment ] [ Designated as safety issue: Yes ]
  • Analysis of biomarkers linked with immunomodulation/cytokine release [ Time Frame: Days 1, 14, 29 and 57 ] [ Designated as safety issue: Yes ]
  • Analysis of exploratory pharmacodynamic biomarkers [ Time Frame: Days 1 and 21 ] [ Designated as safety issue: Yes ]
  • Efficacy as measured by: Objective Response Rate of PF-05082566 as a single agent [ Time Frame: Assessed once every 8 weeks up to 2 years during the study treatment and every 2 to 4 months thereafter until progression ] [ Designated as safety issue: Yes ]
  • Efficacy as measured by Objective Response Rate of PF-05082566 and rituximab when given in combination [ Time Frame: Assessed once every 8 weeks up to 2 years during the study treatment and every 2 to 4 months thereafter until progression ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics (Cmax) of PF-05082566 and rituximab when given in combination [ Time Frame: Days -7, 0, 1, 3, 7, 1, 22, 29, 36, 43, 50, 57, 78, 85, 112 and 141, followed by every 28 days during the therapy up to 2 years. ] [ Designated as safety issue: Yes ]
    Pharmacokinetics of PF-05082566 and rituximab when given in combination
  • Pharmacokinetics (AUC) of PF-05082566 and rituximab when given in combination [ Time Frame: Days -7, 0, 1, 3, 7, 1, 22, 29, 36, 43, 50, 57, 78, 85, 112 and 141, followed by every 28 days during the therapy up to 2 years. ] [ Designated as safety issue: Yes ]
    Pharmacokinetics of PF-05082566 and rituximab when given in combination
  • Pharmacokinetics (Cmax) of PF-05082566 as a single agent [ Time Frame: Days 1, 3, 8, 15, 22, 29, 31, 36, 43, 50, 57, 64, 71, 78, 85, 87, 112, followed by every 28 days during the therapy up to 2 years, then Days 28, 57 and 85 after the administration of the last dose. ] [ Designated as safety issue: Yes ]
    Pharmacokinetics of PF-05082566 and rituximab when given in combination
  • Pharmacokinetics (AUC) of PF-05082566 as a single agent [ Time Frame: Days 1, 3, 8, 15, 22, 29, 31, 36, 43, 50, 57, 64, 71, 78, 85, 87, 112, followed by every 28 days during the therapy up to 2 years, then Days 28, 57 and 85 after the administration of the last dose. ] [ Designated as safety issue: Yes ]
    Pharmacokinetics of PF-05082566 and rituximab when given in combination
  • Efficacy as measured by: Duration of Response of PF-05082566 and rituximab when given in combination [ Time Frame: Assessed once every 8 weeks up to 2 years during the study treatment and every 2 to 4 months thereafter until progression ] [ Designated as safety issue: Yes ]
  • Efficacy as measured by Progression Free Survival of PF-05082566 and rituximab when given in combination [ Time Frame: Assessed once every 8 weeks up to 2 years during the study treatment and every 2 to 4 months thereafter until progression ] [ Designated as safety issue: Yes ]
  • Efficacy as measured by Overall Survival of PF-05082566 and rituximab when given in combination [ Time Frame: Assessed once every 8 weeks up to 2 years during the study treatment and every 2 to 4 months thereafter until progression ] [ Designated as safety issue: Yes ]
  • Efficacy as measured by Duration of Response of PF-05082566 as a single agent [ Time Frame: Assessed once every 8 weeks up to 2 years during the study treatment and every 2 to 4 months thereafter until progression ] [ Designated as safety issue: Yes ]
  • Efficacy as measured by Progression Free Survival of PF-05082566 given as a single agent [ Time Frame: Assessed once every 8 weeks up to 2 years during the study treatment and every 2 to 4 months thereafter until progression ] [ Designated as safety issue: Yes ]
  • Efficacy as measured by Overall Survival of PF-05082566 given as a single agent [ Time Frame: Assessed once every 8 weeks up to 2 years during the study treatment and every 2 to 4 months thereafter until progression ] [ Designated as safety issue: Yes ]
  • Adverse events, laboratory abnormalities [ Time Frame: Throughout Study ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics, Pharmacodynamics, Biomarkers [ Time Frame: Throughout Study ] [ Designated as safety issue: Yes ]
  • Anti-Drug Antibody levels [ Time Frame: Throughout Study ] [ Designated as safety issue: Yes ]
  • QTc interval [ Time Frame: Throughout Study ] [ Designated as safety issue: Yes ]
  • Efficacy [ Time Frame: Throughout Study ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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
  • 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: A
    PF-05082566 single agent in patients with advanced cancer
    Intervention: Drug: PF-05082566
  • Experimental: 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
220
July 2017
July 2017   (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.
Both
18 Years and older   (Adult, Senior)
No
Contact: Pfizer CT.gov Call Center 1-800-718-1021
United States,   France,   Italy,   Japan
 
NCT01307267
B1641001, 2011-002799-17
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2016

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