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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04262856
Ethics application status
Date submitted
23/01/2020
Date registered
10/02/2020
Date last updated
5/11/2020

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
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 - Zimberelimab
Treatment: Drugs - Domvanalimab
Treatment: Drugs - Etrumadenant

Experimental: Arm 1 (zimberelimab monotherapy) - Participants will receive zimberelimab monotherapy by IV infusion.

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

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


Treatment: Drugs: Zimberelimab
Zimberelimab is a fully human anti-PD-1 monoclononal antibody

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

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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective response rate (ORR) - ORR as assessed by RECIST v1.1
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) - PFS as assessed by RECIST v1.1
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) - DoR as assessed by RECIST v1.1
Timepoint [1] 0 0
From the date of first occurence 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) - DCR as assessed by RECIST v1.1
Timepoint [2] 0 0
From the date of first occurence 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
Adverse Events - The number and percentage of participants that experience an adverse event (AE)
Timepoint [3] 0 0
From Screening until up to 100 days after the last dose (approximately 2 years)
Secondary outcome [4] 0 0
Pharmacodynamics of zimberelimab - Plasma concentration of zimberelimab
Timepoint [4] 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 [5] 0 0
Pharmacodynamics of domvanalimab - Plasma concentration of domvanalimab
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
Pharmacodynamics of etrumadenant - Plasma concentration of etrumadenant
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
Immunogenicity of zimberelimab - Percentage of participants who develop treatment-emergent anti-drug antibodies to zimberelimab
Timepoint [7] 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 [8] 0 0
Immunogenicity of domvanalimab - Percentage of participants who develop treatment-emergent anti-drug antibodies to domvanalimab
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).

Eligibility
Key inclusion criteria
- Male or female participants; age = 18 years

- Histologically confirmed squamous or nonsquamous, PD-L1 positive, NSCLC that is
locally advanced or metastatic without sensitizing epidermal growth factor receptor
(EGFR) or anaplastic lymphoma kinase (ALK) mutation expression

- 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
Gender
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

- 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 or
Hepatitis C qualitative RNA or human immunodeficiency virus-1 (HIV-1) antibody

- 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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
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
Shoalhaven Cancer Care Centre - Nowra
Recruitment hospital [4] 0 0
Tweed Hospital - Tweed Heads
Recruitment hospital [5] 0 0
Adelaide Cancer Centre - Elizabeth Vale
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [3] 0 0
2500 - Nowra
Recruitment postcode(s) [4] 0 0
2485 - Tweed Heads
Recruitment postcode(s) [5] 0 0
5112 - Elizabeth Vale
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
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Mississippi
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
New Jersey
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Pennsylvania
Country [15] 0 0
United States of America
State/province [15] 0 0
Tennessee
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Virginia
Country [18] 0 0
United States of America
State/province [18] 0 0
Washington
Country [19] 0 0
Hong Kong
State/province [19] 0 0
Hong Kong
Country [20] 0 0
Korea, Republic of
State/province [20] 0 0
Cheongju-si
Country [21] 0 0
Korea, Republic of
State/province [21] 0 0
Hwasun
Country [22] 0 0
Korea, Republic of
State/province [22] 0 0
Jeonju
Country [23] 0 0
Korea, Republic of
State/province [23] 0 0
Seongnam-si
Country [24] 0 0
Korea, Republic of
State/province [24] 0 0
Seoul
Country [25] 0 0
Korea, Republic of
State/province [25] 0 0
Suwon-si
Country [26] 0 0
Singapore
State/province [26] 0 0
Singapore
Country [27] 0 0
Taiwan
State/province [27] 0 0
Kaohsiung City
Country [28] 0 0
Taiwan
State/province [28] 0 0
New Taipei
Country [29] 0 0
Taiwan
State/province [29] 0 0
Taichung City
Country [30] 0 0
Taiwan
State/province [30] 0 0
Tainan City
Country [31] 0 0
Taiwan
State/province [31] 0 0
Tainan
Country [32] 0 0
Taiwan
State/province [32] 0 0
Taipei City
Country [33] 0 0
Taiwan
State/province [33] 0 0
Taipei
Country [34] 0 0
Taiwan
State/province [34] 0 0
Taoyuan

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

Ethics approval
Ethics application status

Summary
Brief summary
This randomized phase 2 open-label study will evaluate the safety and efficacy of
zimberelimab (AB122) monotherapy, domvanalimab (AB154) in combination with zimberelimab, and
domvanalimab in combination with zimberelimab and etrumadenant (AB928) in front-line, PD-L1
positive, locally advanced or metastatic non-small cell lung cancer.
Trial website
https://clinicaltrials.gov/show/NCT04262856
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
Medical Director
Address 0 0
Country 0 0
Phone 0 0
510-694-6220
Fax 0 0
Email 0 0
clinicaltrialinquiry@arcusbio.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04262856