Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02410512