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A Study to Assess the Safety and Pharmacokinetics of MOXR0916 and Atezolizumab (Also Known as MPDL3280A or Anti-PD-L1) in Participants With Locally Advanced or Metastatic Solid Tumors

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ClinicalTrials.gov Identifier: NCT02410512
Recruitment Status : Completed
First Posted : April 7, 2015
Last Update Posted : March 1, 2021
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Tracking Information
First Submitted Date  ICMJE April 2, 2015
First Posted Date  ICMJE April 7, 2015
Last Update Posted Date March 1, 2021
Actual Study Start Date  ICMJE April 24, 2015
Actual Primary Completion Date November 22, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2017)
  • Number of Participants with Dose-Limiting Toxicities (DLTs) [ Time Frame: Days (D) 1-21 of Cycle (C) 1 (cycle = 21 days); up to D42 if extended monitoring warranted ]
  • Number of Participants with Adverse Events Graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.0 [ Time Frame: Baseline until 90 days after last dose or initiation of another systemic anti-cancer therapy, whichever occurs first (up to 3 years) ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 2, 2015)
  • Incidence of dose-limiting toxicities (DLTs) [ Time Frame: up to 21 to 42 days after the first dose of study treatment ]
  • Incidence of adverse events graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.0 [ Time Frame: up to 90 days after the last dose of study treatment, or until the initiation of another systemic anti-cancer therapy, whichever occurs first ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2017)
  • Maximum Tolerated Dose (MTD) of MOXR0916 [ Time Frame: Up to 1 year ]
  • Recommended Phase II Dose (RP2D) of MOXR0916 [ Time Frame: Up to 1 year ]
  • Percentage of Participants with Anti-MOXR0916 and Anti-Atezolizumab Antibodies [ Time Frame: Up to 120 days after the treatment discontinuation visit ]
  • Number of Cycles Received with MOXR0916 [ Time Frame: Baseline until treatment discontinuation (up to 3 years) ]
  • Dose Intensity of MOXR0916 [ Time Frame: Baseline until treatment discontinuation (up to 3 years) ]
  • Area under the Concentration-Time Curve (AUC) of MOXR0916 [ Time Frame: Up to 120 days after the treatment discontinuation visit ]
  • Serum Maximum Observed Concentration (Cmax) of MOXR0916 [ Time Frame: Up to 120 days after the treatment discontinuation visit ]
  • Serum Minimum Observed Concentration (Cmin) of MOXR0916 [ Time Frame: Up to 120 days after the treatment discontinuation visit ]
  • Clearance (CL) of MOXR0916 [ Time Frame: Up to 120 days after the treatment discontinuation visit ]
  • Volume of Distribution at Steady State (Vss) of MOXR0916 [ Time Frame: Up to 120 days after the treatment discontinuation visit ]
  • Serum Cmax of Atezolizumab [ Time Frame: Up to 120 days after the treatment discontinuation visit ]
  • Serum Cmin of Atezolizumab [ Time Frame: Up to 120 days after the treatment discontinuation visit ]
  • Percentage of Participants with Objective Response Determined Using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Baseline until disease progression (up to 3 years) ]
  • Duration of Objective Response (DOR) Determined Using RECIST v1.1 [ Time Frame: From first objective response until death or relapse per RECIST v1.1, whichever occurs first (up to 3 years) ]
  • Progression-Free Survival (PFS) Determined Using RECIST v1.1 [ Time Frame: Baseline until death or disease progression per RECIST v1.1, whichever occurs first (up to 3 years) ]
  • Percentage of Participants with Objective Response Determined Using Modified RECIST [ Time Frame: Baseline until disease progression (up to 3 years) ]
  • DOR Determined Using Modified RECIST [ Time Frame: From first objective response until death or relapse per RECIST v1.1, whichever occurs first (up to 3 years) ]
  • PFS Determined Using Modified RECIST [ Time Frame: Baseline until death or disease progression per RECIST v1.1, whichever occurs first (up to 3 years) ]
  • Overall Survival (OS) [ Time Frame: Baseline until death (up to 3 years) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2015)
  • Maximum tolerated dose (MTD) [ Time Frame: Up to 1 year ]
  • Pharmacokinetic parameters derived from serum MOXR0916 and serum MPDL3280A concentrations: area under the concentration-time curve (AUC), maximum and minimum serum concentrations (Cmax and Cmin), clearance and volume of distribution at steady state [ Time Frame: Up to 120 days after the treatment discontinuation visit ]
  • Incidence of anti-MOXR0916 and anti-MPDL3280A antibodies [ Time Frame: Up to 120 days after the treatment discontinuation visit ]
  • Objective response determined using RECIST v.1.1 [ Time Frame: Assessed at regular intervals until disease progression, up to 3 years ]
  • Duration of response determined using RECIST v.1.1 [ Time Frame: Assessed at regular intervals until disease progression, up to 3 years ]
  • Progression-free survival (PFS) determined using RECIST v.1.1 [ Time Frame: Assessed at regular intervals until disease progression, up to 3 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Safety and Pharmacokinetics of MOXR0916 and Atezolizumab (Also Known as MPDL3280A or Anti-PD-L1) in Participants With Locally Advanced or Metastatic Solid Tumors
Official Title  ICMJE A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of MOXR0916 and Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors
Brief Summary This Phase Ib, open-label, dose-escalation study will evaluate the safety, tolerability, and pharmacokinetics of the combination of MOXR0916 and atezolizumab in participants with locally advanced, recurrent, or metastatic incurable solid malignancy that has progressed after available standard therapy; or for which standard therapy has proven to be ineffective or intolerable or is considered inappropriate; or for which a clinical trial of an investigational agent is a recognized standard of care. Participants will be enrolled in two stages: a dose-escalation stage and an expansion stage.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neoplasms
Intervention  ICMJE
  • Drug: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 [PD-L1] antibody
    Atezolizumab will be administered intravenously.
    Other Name: Tecentriq
  • Drug: MOXR0916, a humanized agonist anti-OX40 monoclonal antibody
    MOXR0916 will be administered intravenously.
Study Arms  ICMJE
  • Experimental: Dose Escalation: MOXR0916 + Atezolizumab
    Cohorts of at least 3 participants each will be treated at escalating doses of MOXR0916 in combination with a fixed dose of atezolizumab to determine the MTD or maximum administered dose (MAD).
    Interventions:
    • Drug: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 [PD-L1] antibody
    • Drug: MOXR0916, a humanized agonist anti-OX40 monoclonal antibody
  • Experimental: Expansion: MOXR0916 + Atezolizumab
    Approximately 250-580 participants will be enrolled in the expansion stage to better characterize the safety, tolerability, pharmacokinetic variability, biomarkers of anti-tumor activity, and preliminary efficacy of MOXR0916 + atezolizumab in different cancer types.
    Interventions:
    • Drug: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 [PD-L1] antibody
    • Drug: MOXR0916, a humanized agonist anti-OX40 monoclonal antibody
Publications * Not Provided

*   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: July 6, 2017)
610
Original Estimated Enrollment  ICMJE
 (submitted: April 2, 2015)
360
Actual Study Completion Date  ICMJE November 22, 2019
Actual Primary Completion Date November 22, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Life expectancy of at least 12 weeks
  • Adequate hematologic and end organ function
  • Histologic documentation of locally advanced, recurrent, or metastatic incurable solid malignancy that has progressed after available standard therapy; or for which standard therapy is ineffective, intolerable, or considered inappropriate; or for which a clinical trial of an investigational agent is recognized standard of care
  • Tumor specimen availability
  • Measurable disease according to RECIST v1.1

Exclusion Criteria:

  • Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study treatment
  • Malignancies other than disease under study within 5 years prior to D1 of C1
  • Primary central nervous system (CNS) malignancy, or untreated/active CNS metastases
  • History of leptomeningeal disease
  • History of idiopathic pulmonary fibrosis, pneumonitis (including drug-induced), organizing pneumonia, or evidence of active pneumonitis on screening chest computed tomography scan; history of radiation pneumonitis in the radiation field (fibrosis) is permitted
  • History of autoimmune disease
  • Positive human immunodeficiency virus test result
  • Active hepatitis B, hepatitis C, or tuberculosis
  • Severe infection within 4 weeks prior to D1 of C1
  • Prior allogeneic bone marrow or solid organ transplantation
  • Significant cardiovascular disease
  • Known clinically significant liver disease
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,   Belgium,   Canada,   France,   Korea, Republic of,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02410512
Other Study ID Numbers  ICMJE GO29674
2015-000516-18 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Genentech, Inc.
Verification Date February 2021

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