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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

This study is currently recruiting participants.
Verified November 2017 by Genentech, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02410512
First Posted: April 7, 2015
Last Update Posted: November 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Genentech, Inc.
  Purpose
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.

Condition Intervention Phase
Neoplasms Drug: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 [PD-L1] antibody Drug: MOXR0916, a humanized agonist anti-OX40 monoclonal antibody Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • 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) ]

Secondary Outcome Measures:
  • 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) ]

Estimated Enrollment: 610
Actual Study Start Date: April 24, 2015
Estimated Study Completion Date: August 12, 2018
Estimated Primary Completion Date: August 12, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).
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.
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.
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 (CT) scan; history of radiation pneumonitis in the radiation field (fibrosis) is permitted
  • History of autoimmune disease
  • Positive human immunodeficiency virus (HIV) 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02410512


Contacts
Contact: Reference Study ID Number: GO29674 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

  Show 31 Study Locations
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT02410512     History of Changes
Other Study ID Numbers: GO29674
2015-000516-18 ( EudraCT Number )
First Submitted: April 2, 2015
First Posted: April 7, 2015
Last Update Posted: November 17, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Atezolizumab
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents