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NCT Number: NCT02410512

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 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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 [PD-L1] antibody

Drug

Atezolizumab will be administered intravenously.

Other names: Tecentriq

MOXR0916, a humanized agonist anti-OX40 monoclonal antibody

Drug

MOXR0916 will be administered intravenously.

Primary outcomes

  1. 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

  2. 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 outcomes

  1. Maximum Tolerated Dose (MTD) of MOXR0916

    Time frame: Up to 1 year

  2. Recommended Phase II Dose (RP2D) of MOXR0916

    Time frame: Up to 1 year

  3. Percentage of Participants with Anti-MOXR0916 and Anti-Atezolizumab Antibodies

    Time frame: Up to 120 days after the treatment discontinuation visit

  4. Number of Cycles Received with MOXR0916

    Time frame: Baseline until treatment discontinuation (up to 3 years)

  5. Dose Intensity of MOXR0916

    Time frame: Baseline until treatment discontinuation (up to 3 years)

  6. Area under the Concentration-Time Curve (AUC) of MOXR0916

    Time frame: Up to 120 days after the treatment discontinuation visit

  7. Serum Maximum Observed Concentration (Cmax) of MOXR0916

    Time frame: Up to 120 days after the treatment discontinuation visit

  8. Serum Minimum Observed Concentration (Cmin) of MOXR0916

    Time frame: Up to 120 days after the treatment discontinuation visit

  9. Clearance (CL) of MOXR0916

    Time frame: Up to 120 days after the treatment discontinuation visit

  10. Volume of Distribution at Steady State (Vss) of MOXR0916

    Time frame: Up to 120 days after the treatment discontinuation visit

  11. Serum Cmax of Atezolizumab

    Time frame: Up to 120 days after the treatment discontinuation visit

  12. Serum Cmin of Atezolizumab

    Time frame: Up to 120 days after the treatment discontinuation visit

  13. 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)

  14. 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)

  15. 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)

  16. Percentage of Participants with Objective Response Determined Using Modified RECIST

    Time frame: Baseline until disease progression (up to 3 years)

  17. 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)

  18. PFS Determined Using Modified RECIST

    Time frame: Baseline until death or disease progression per RECIST v1.1, whichever occurs first (up to 3 years)

  19. Overall Survival (OS)

    Time frame: Baseline until death (up to 3 years)

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Apr 7, 2015
Registry last updated
Apr 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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