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Trial record 1 of 1 for:    go29674
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A Dose-Escalation Study of the Safety and Pharmacokinetics of MOXR0916 and Atezolizumab With or Without Bevacizumab in Participants With Locally Advanced or Metastatic Solid Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by Genentech, Inc.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT02410512
First received: April 2, 2015
Last updated: November 1, 2016
Last verified: November 2016
  Purpose
This Phase Ib, open-label, dose-escalation study will evaluate the safety, tolerability, and pharmacokinetics of the combination of MOXR0916 and Atezolizumab with or without bevacizumab 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.

Condition Intervention Phase
Solid Tumor
Drug: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody
Drug: Bevacizumab, a recombinant humanised anti-VEGF (vascular endothelial growth factor) monoclonal antibody
Drug: MOXR0916, a humanized agonist anti-OX40 monoclonal antibody
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of MOXR0916 and Atezolizumab With or Without Bevacizumab 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:
  • 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 ]

Secondary Outcome Measures:
  • Maximum tolerated dose (MTD) [ Time Frame: Up to 1 year ]
  • Pharmacokinetic parameters derived from serum MOXR0916 and serum atezolizumab 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 ]
  • Overall survival (OS) determined as the time from first study treatment to death from any cause [ Time Frame: Assessed at regular intervals until death, up to 3 years ]
  • Incidence of anti-MOXR0916, anti-atezolizumab, and anti-bevacizumab antibodies [ Time Frame: Up to 120 days after the treatment discontinuation visit ]
  • Percentage of participants with objective response complete respons (CR) or partial response (PR) 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 ]

Estimated Enrollment: 762
Study Start Date: April 2015
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Doublet Dose Escalation: MOXR0916+Atezolizumab
Cohort 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) [TECENTRIQ], an engineered anti-PDL1 antibody
Atezolizumab administered intravenously
Drug: MOXR0916, a humanized agonist anti-OX40 monoclonal antibody
MOXR0916 administered intravenously
Experimental: Doublet Expansion: MOXR0916+Atezolizumab
Approximately 250 to 620 participants will be enrolled in the expansion stage to better characterize the safety, tolerability, PK variability, biomarkers of anti-tumor activity, and preliminary efficacy of MOXR0916 + Atezolizumab in different cancer types.
Drug: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody
Atezolizumab administered intravenously
Drug: MOXR0916, a humanized agonist anti-OX40 monoclonal antibody
MOXR0916 administered intravenously
Experimental: Triplet Dose Escalation: MOXR0916+Atezolizumab+Bevacizumab
Cohort of at least 3 participants each will be treated at escalating doses of MOXR0916 in combination with fixed doses of atezolizumab and bevacizumab to determine the MTD or MAD.
Drug: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody
Atezolizumab administered intravenously
Drug: Bevacizumab, a recombinant humanised anti-VEGF (vascular endothelial growth factor) monoclonal antibody
Bevacizumab administered intravenously
Drug: MOXR0916, a humanized agonist anti-OX40 monoclonal antibody
MOXR0916 administered intravenously
Experimental: Triplet Expansion: MOXR0916+Atezolizumab+Bevacizumab
Approximately 30 to 100 participants will be enrolled to better characterize the safety, tolerability, PK variability, biomarkers of anti-tumor activity, and preliminary efficacy of MOXR0916 + Atezolizumab + bevacizumab in different cancer types.
Drug: Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody
Atezolizumab administered intravenously
Drug: Bevacizumab, a recombinant humanised anti-VEGF (vascular endothelial growth factor) monoclonal antibody
Bevacizumab administered intravenously
Drug: MOXR0916, a humanized agonist anti-OX40 monoclonal antibody
MOXR0916 administered intravenously

  Eligibility

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

Inclusion Criteria:

  • Patients 18 years of age or older
  • 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 Response Evaluation Criteria in Solid Tumors (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 Cycle 1, Day 1
  • Primary central nervous system (CNS) malignancy, or untreated/active CNS metastase
  • 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
  • Active hepatitis B or C, or tuberculosis
  • Severe infection within 4 weeks prior to randomization
  • Prior allogenic bone marrow or solid organ transplantation
  • Significant cardiovascular disease
  • Known clinically significant liver disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02410512

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

  Show 26 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 )
Study First Received: April 2, 2015
Last Updated: November 1, 2016

Additional relevant MeSH terms:
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Bevacizumab
Endothelial Growth Factors
Mitogens
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2017