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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02410512




Registration number
NCT02410512
Ethics application status
Date submitted
2/04/2015
Date registered
7/04/2015
Date last updated
1/04/2022

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
2015-000516-18
Secondary ID [2] 0 0
GO29674
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplasms 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 [PD-L1] antibody
Treatment: Drugs - MOXR0916, a humanized agonist anti-OX40 monoclonal antibody

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).

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.


Treatment: Drugs: Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 [PD-L1] antibody
Atezolizumab will be administered intravenously.

Treatment: Drugs: MOXR0916, a humanized agonist anti-OX40 monoclonal antibody
MOXR0916 will be administered intravenously.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Dose-Limiting Toxicities (DLTs)
Timepoint [1] 0 0
Days (D) 1-21 of Cycle (C) 1 (cycle = 21 days); up to D42 if extended monitoring warranted
Primary outcome [2] 0 0
Number of Participants with Adverse Events Graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.0
Timepoint [2] 0 0
Baseline until 90 days after last dose or initiation of another systemic anti-cancer therapy, whichever occurs first (up to 3 years)
Secondary outcome [1] 0 0
Maximum Tolerated Dose (MTD) of MOXR0916
Timepoint [1] 0 0
Up to 1 year
Secondary outcome [2] 0 0
Recommended Phase II Dose (RP2D) of MOXR0916
Timepoint [2] 0 0
Up to 1 year
Secondary outcome [3] 0 0
Percentage of Participants with Anti-MOXR0916 and Anti-Atezolizumab Antibodies
Timepoint [3] 0 0
Up to 120 days after the treatment discontinuation visit
Secondary outcome [4] 0 0
Number of Cycles Received with MOXR0916
Timepoint [4] 0 0
Baseline until treatment discontinuation (up to 3 years)
Secondary outcome [5] 0 0
Dose Intensity of MOXR0916
Timepoint [5] 0 0
Baseline until treatment discontinuation (up to 3 years)
Secondary outcome [6] 0 0
Area under the Concentration-Time Curve (AUC) of MOXR0916
Timepoint [6] 0 0
Up to 120 days after the treatment discontinuation visit
Secondary outcome [7] 0 0
Serum Maximum Observed Concentration (Cmax) of MOXR0916
Timepoint [7] 0 0
Up to 120 days after the treatment discontinuation visit
Secondary outcome [8] 0 0
Serum Minimum Observed Concentration (Cmin) of MOXR0916
Timepoint [8] 0 0
Up to 120 days after the treatment discontinuation visit
Secondary outcome [9] 0 0
Clearance (CL) of MOXR0916
Timepoint [9] 0 0
Up to 120 days after the treatment discontinuation visit
Secondary outcome [10] 0 0
Volume of Distribution at Steady State (Vss) of MOXR0916
Timepoint [10] 0 0
Up to 120 days after the treatment discontinuation visit
Secondary outcome [11] 0 0
Serum Cmax of Atezolizumab
Timepoint [11] 0 0
Up to 120 days after the treatment discontinuation visit
Secondary outcome [12] 0 0
Serum Cmin of Atezolizumab
Timepoint [12] 0 0
Up to 120 days after the treatment discontinuation visit
Secondary outcome [13] 0 0
Percentage of Participants with Objective Response Determined Using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Timepoint [13] 0 0
Baseline until disease progression (up to 3 years)
Secondary outcome [14] 0 0
Duration of Objective Response (DOR) Determined Using RECIST v1.1
Timepoint [14] 0 0
From first objective response until death or relapse per RECIST v1.1, whichever occurs first (up to 3 years)
Secondary outcome [15] 0 0
Progression-Free Survival (PFS) Determined Using RECIST v1.1
Timepoint [15] 0 0
Baseline until death or disease progression per RECIST v1.1, whichever occurs first (up to 3 years)
Secondary outcome [16] 0 0
Percentage of Participants with Objective Response Determined Using Modified RECIST
Timepoint [16] 0 0
Baseline until disease progression (up to 3 years)
Secondary outcome [17] 0 0
DOR Determined Using Modified RECIST
Timepoint [17] 0 0
From first objective response until death or relapse per RECIST v1.1, whichever occurs first (up to 3 years)
Secondary outcome [18] 0 0
PFS Determined Using Modified RECIST
Timepoint [18] 0 0
Baseline until death or disease progression per RECIST v1.1, whichever occurs first (up to 3 years)
Secondary outcome [19] 0 0
Overall Survival (OS)
Timepoint [19] 0 0
Baseline until death (up to 3 years)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/04/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/11/2019
Sample size
Target
Accrual to date
Final
610
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [3] 0 0
Peter Maccallum Cancer Centre - Melbourne
Recruitment hospital [4] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3084 - Heidelberg
Recruitment postcode(s) [3] 0 0
3000 - Melbourne
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Tennessee
Country [8] 0 0
United States of America
State/province [8] 0 0
Washington
Country [9] 0 0
Belgium
State/province [9] 0 0
Anderlecht
Country [10] 0 0
Belgium
State/province [10] 0 0
Gent
Country [11] 0 0
Belgium
State/province [11] 0 0
Wilrijk
Country [12] 0 0
Canada
State/province [12] 0 0
British Columbia
Country [13] 0 0
Canada
State/province [13] 0 0
Ontario
Country [14] 0 0
Canada
State/province [14] 0 0
Quebec
Country [15] 0 0
France
State/province [15] 0 0
Villejuif CEDEX
Country [16] 0 0
Korea, Republic of
State/province [16] 0 0
Seoul
Country [17] 0 0
Spain
State/province [17] 0 0
Navarra
Country [18] 0 0
Spain
State/province [18] 0 0
Barcelona
Country [19] 0 0
Spain
State/province [19] 0 0
Madrid
Country [20] 0 0
Spain
State/province [20] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Genentech, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02410512
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02410512