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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04262856




Registration number
NCT04262856
Ethics application status
Date submitted
23/01/2020
Date registered
10/02/2020

Titles & IDs
Public title
Study to Evaluate Monotherapy and Combination Immunotherapies in Participants With PD-L1 Positive Non-small Cell Lung Cancer
Scientific title
A Phase 2 Study to Evaluate the Safety and Efficacy of AB122 Monotherapy, AB154 in Combination With AB122, and AB154 in Combination With AB122 and AB928 in Front-Line, Non-Small Cell Lung Cancer
Secondary ID [1] 0 0
ARC-7 (AB154CSP0002)
Universal Trial Number (UTN)
Trial acronym
ARC-7
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non Small Cell Lung Cancer 0 0
Nonsquamous Non Small Cell Lung Cancer 0 0
Squamous Non Small Cell Lung Cancer 0 0
Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Domvanalimab
Treatment: Drugs - Etrumadenant
Treatment: Drugs - Zimberelimab

Experimental: Arm 1 (zimberelimab monotherapy) - Participants will receive zimberelimab as an intravenous (IV) infusion.

Experimental: Arm 2 (domvanalimab and zimberelimab combination therapy) - Participants will receive domvanalimab IV in combination with zimberelimab IV infusion.

Experimental: Arm 3 (domvanalimab, etrumadenant, and zimberelimab combination therapy) - Participants will receive oral etrumadenant in combination with domvanalimab IV and zimberelimab IV infusion


Treatment: Drugs: Domvanalimab
Domvanalimab is a humanized monoclonal antibody targeting human TIGIT

Treatment: Drugs: Etrumadenant
Etrumadenant is an A2aR and A2bR antagonist

Treatment: Drugs: Zimberelimab
Zimberelimab is a fully human anti-PD-1 monoclonal antibody
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective response rate (ORR)
Timepoint [1] 0 0
From randomization until death from any cause (up to approximately 3-5 years)
Primary outcome [2] 0 0
Progression-free survival (PFS)
Timepoint [2] 0 0
From randomization until death from any cause (up to approximately 3-5 years)
Secondary outcome [1] 0 0
Duration of response (DoR)
Timepoint [1] 0 0
From the date of first occurrence of a documented objective response to first documentation of disease progression or death from any cause, whichever occurs first (up to approximately 3-5 years)
Secondary outcome [2] 0 0
Disease control rate (DCR)
Timepoint [2] 0 0
From the date of first occurrence of a documented objective response to first documentation of disease progression on death from any cause, whichever occurs first (up to approximately 3-5 years)
Secondary outcome [3] 0 0
Overall Survival (OS)
Timepoint [3] 0 0
From randomization to death from any cause (up to approximately 5 years)
Secondary outcome [4] 0 0
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Timepoint [4] 0 0
From Screening until up to 30 days after the last dose (approximately 5 years)
Secondary outcome [5] 0 0
Pharmacokinetics of zimberelimab
Timepoint [5] 0 0
Collected during all treatment cycles (each cycle is 21 or 28 days), up to 14 days post last dose, 30, 60 and 100 days post last dose (in total, an average of 2 years)
Secondary outcome [6] 0 0
Pharmacokinetics of domvanalimab
Timepoint [6] 0 0
Collected during all treatment cycles (each cycle is 21 or 28 days), up to 14 days post last dose, 30, 60 and 100 days post last dose (in total, an average of 2 years)
Secondary outcome [7] 0 0
Pharmacokinetics of etrumadenant
Timepoint [7] 0 0
Collected during all treatment cycles (each cycle is 21 or 28 days), up to 14 days post last dose, 30, 60 and 100 days post last dose (in total, an average of 2 years)
Secondary outcome [8] 0 0
Immunogenicity of zimberelimab
Timepoint [8] 0 0
Collected during all treatment cycles (each cycle is 21 or 28 days), up to 14 days post last dose, 30, and 100 days post last dose (in total, an average of 2 years).
Secondary outcome [9] 0 0
Immunogenicity of domvanalimab
Timepoint [9] 0 0
Collected during all treatment cycles (each cycle is 21 or 28 days), up to 14 days post last dose, 30, and 100 days post last dose (in total, an average of 2 years).

Eligibility
Key inclusion criteria
* Male or female participants; age = 18 years
* Histologically confirmed, treatment naïve, metastatic squamous or non-squamous NSCLC with documented high PD-L1 expression, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
* Must have at least 1 measurable lesion per RECIST v1.1
* Adequate organ and marrow function
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Use of any live vaccines against infectious diseases within 28 days of first dose of investigational medicinal products (IMPs)
* Any gastrointestinal condition that would preclude the use of oral medications (eg, difficulty swallowing, nausea, vomiting, or malabsorption)
* History of trauma or major surgery within 28 days prior to the first dose of IMP
* Concurrent medical condition requiring the use of supra-physiologic doses of corticosteroids (> 10 mg/day of oral prednisone or equivalent) or immunosuppressive medications
* Positive test results for Hepatitis B surface antigen, Hepatitis C virus antibody with presence of Hepatitis C qualitative RNA or human immunodeficiency virus (HIV-1 and/or HIV-2) antibody at screening
* Any active autoimmune disease or a documented history of autoimmune disease or syndrome that required systemic treatment in the past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs), except for vitiligo or resolved childhood asthma/atopy.
* Prior malignancy active within the previous 2 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast, or prostate cancer

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/05/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2025
Actual
Sample size
Target
Accrual to date
Final
151
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Border Medical Oncology - Albury
Recruitment hospital [2] 0 0
Coffs Harbour Health Campus - Coffs Harbour
Recruitment hospital [3] 0 0
Adelaide Cancer Centre - Elizabeth Vale
Recruitment hospital [4] 0 0
Shoalhaven Cancer Care Centre - Nowra
Recruitment postcode(s) [1] 0 0
- Albury
Recruitment postcode(s) [2] 0 0
- Coffs Harbour
Recruitment postcode(s) [3] 0 0
- Elizabeth Vale
Recruitment postcode(s) [4] 0 0
- Nowra
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Mississippi
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
Tennessee
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Virginia
Country [14] 0 0
Canada
State/province [14] 0 0
Montreal
Country [15] 0 0
Hong Kong
State/province [15] 0 0
Hong Kong
Country [16] 0 0
Korea, Republic of
State/province [16] 0 0
Busan
Country [17] 0 0
Korea, Republic of
State/province [17] 0 0
Hwasun
Country [18] 0 0
Korea, Republic of
State/province [18] 0 0
Incheon
Country [19] 0 0
Korea, Republic of
State/province [19] 0 0
Jeonju
Country [20] 0 0
Korea, Republic of
State/province [20] 0 0
Seongnam-si
Country [21] 0 0
Korea, Republic of
State/province [21] 0 0
Seoul
Country [22] 0 0
Korea, Republic of
State/province [22] 0 0
Suwon-si
Country [23] 0 0
Korea, Republic of
State/province [23] 0 0
Uijeongbu
Country [24] 0 0
Singapore
State/province [24] 0 0
Singapore
Country [25] 0 0
Taiwan
State/province [25] 0 0
New Taipei
Country [26] 0 0
Taiwan
State/province [26] 0 0
Tainan City
Country [27] 0 0
Taiwan
State/province [27] 0 0
Tainan
Country [28] 0 0
Taiwan
State/province [28] 0 0
Taipei
Country [29] 0 0
Taiwan
State/province [29] 0 0
Taoyuan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Arcus Biosciences, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Gilead Sciences
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Arcus Biosciences, Inc.
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Arcus will provide access to individual de-identified participant data and related study documents (e.g., protocol, Statistical Analysis Plan \[SAP\], Clinical Study Report \[CSR\]) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.

For more information, please visit our website.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://trials.arcusbio.com/our-transparency-policy


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/NCT04262856