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AzTrials

NeoplasmsPhase 1NCT02410512

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

A Phase 1 study testing Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 [PD-L1] antibody and MOXR0916, a humanized agonist anti-OX40 monoclonal antibody in people with Neoplasms, run by Genentech, Inc. at 27 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasms
What is being tested?
Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 [PD-L1] antibody and MOXR0916, a humanized agonist anti-OX40 monoclonal antibody
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
610 participants
Where
27 sitesin 7 countries
Study dates
24 Apr 2015to 22 Nov 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

27 sites in 7 countries.

27 sites in 7 countries

United States9 sites

  • University of Colorado

    Aurora, Colorado, 80045-2517

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana Farber Can Ins

    Boston, Massachusetts, 02215

  • University Of Chicago Medical Center; Section Of Hematology/Oncology

    Chicago, Illinois, 60637

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Yale School of Medicine

    New Haven, Connecticut, 06510

  • HonorHealth Research Institute - Bisgrove

    Scottsdale, Arizona, 85258

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Georgetown University Medical Center Lombardi Cancer Center

    Washington D.C., District of Columbia, 20007

Other trials in United States

Australia4 sites

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050

  • Austin Hospital

    Heidelberg, Victoria, 3084

  • Peter Maccallum Cancer Centre

    Melbourne, Victoria, 3000

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

Other trials in Australia

Spain4 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hosp de Madrid Norte Sanchinarro; Centro Integral; Onco Clara Campal

    Madrid, 28050

  • Clinica Universitaria de Navarra

    Pamplona, Navarre, 31008

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

Other trials in Spain

Belgium3 sites

  • Institut Jules Bordet

    Anderlecht, 1070

  • UZ Gent

    Ghent, 9000

  • Sint Augustinus Wilrijk

    Wilrijk, 2610

Other trials in Belgium

Canada3 sites

  • McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

    Montreal, Quebec, H3T 1E2

  • University Health Network; Princess Margaret Hospital; Medical Oncology Dept

    Toronto, Ontario, M5G 2M9

  • British Columbia Cancer Agency (Bcca) - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

South Korea3 sites

  • Seoul National University Hospital

    Seoul, 03080

  • Asan Medical Center

    Seoul, 05505

  • Yonsei University Health System/Severance Hospital

    Seoul, 120-752

Other trials in South Korea

France1 site

  • Gustave Roussy

    Villejuif, 94800

Other trials in France

About this study

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

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.

Conditions
Neoplasms
Being tested
Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 [PD-L1] antibody, MOXR0916, a humanized agonist anti-OX40 monoclonal antibody
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called Tecentriq

    Atezolizumab will be administered intravenously.

  • MOXR0916, a humanized agonist anti-OX40 monoclonal antibodyDrug

    MOXR0916 will be administered intravenously.

Study groups in NCT02410512
Study groupRoleWhat they receive
Dose Escalation: MOXR0916 + AtezolizumabExperimentalCohorts 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).
Receives: Drug: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 [PD-L1] antibody; Drug: MOXR0916, a humanized agonist anti-OX40 monoclonal antibody
Expansion: MOXR0916 + AtezolizumabExperimentalApproximately 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.
Receives: Drug: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 [PD-L1] antibody; Drug: MOXR0916, a humanized agonist anti-OX40 monoclonal antibody

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Dose-Limiting Toxicities (DLTs)

    Measured: 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

    Measured: Baseline until 90 days after last dose or initiation of another systemic anti-cancer therapy, whichever occurs first (up to 3 years)

Secondary outcomes (19)

  1. Maximum Tolerated Dose (MTD) of MOXR0916

    Measured: Up to 1 year

  2. Recommended Phase II Dose (RP2D) of MOXR0916

    Measured: Up to 1 year

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

    Measured: Up to 120 days after the treatment discontinuation visit

  4. Number of Cycles Received with MOXR0916

    Measured: Baseline until treatment discontinuation (up to 3 years)

  5. Dose Intensity of MOXR0916

    Measured: Baseline until treatment discontinuation (up to 3 years)

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

    Measured: Up to 120 days after the treatment discontinuation visit

  7. Serum Maximum Observed Concentration (Cmax) of MOXR0916

    Measured: Up to 120 days after the treatment discontinuation visit

  8. Serum Minimum Observed Concentration (Cmin) of MOXR0916

    Measured: Up to 120 days after the treatment discontinuation visit

  9. Clearance (CL) of MOXR0916

    Measured: Up to 120 days after the treatment discontinuation visit

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

    Measured: Up to 120 days after the treatment discontinuation visit

  11. Serum Cmax of Atezolizumab

    Measured: Up to 120 days after the treatment discontinuation visit

  12. Serum Cmin of Atezolizumab

    Measured: 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

    Measured: Baseline until disease progression (up to 3 years)

  14. Duration of Objective Response (DOR) Determined Using RECIST v1.1

    Measured: 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

    Measured: 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

    Measured: Baseline until disease progression (up to 3 years)

  17. DOR Determined Using Modified RECIST

    Measured: 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

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

  19. Overall Survival (OS)

    Measured: Baseline until death (up to 3 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2015 (estimated)
  2. Study start24 Apr 2015
  3. Primary completion22 Nov 2019
  4. Study completion22 Nov 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
610 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02410512
Sponsor's protocol ID
GO29674
Other IDs
2015-000516-18, 2015
Status last verified
Mar 2022
First submitted
2 Apr 2015
Last updated
1 Apr 2022
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 [PD-L1] antibody and MOXR0916, a humanized agonist anti-OX40 monoclonal antibody in people with Neoplasms, run by Genentech, Inc. at 27 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States, Australia, Spain, Belgium, Canada and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02410512.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2022.

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