Study to Evaluate Monotherapy and Combination Immunotherapies in Participants With PD-L1 Positive Non-small Cell Lung Cancer (ARC-7)

November 2, 2023 updated by: Arcus Biosciences, Inc.

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

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, metastatic non-small cell lung cancer.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is an open-label phase 2 study in participants with non-small cell lung cancer which will assess the safety, efficacy and tolerability of zimberelimab as monotherapy and in combination with other immunotherapeutics across multiple treatment arms.

Approximately 150 participants will be randomized to 1 of 3 treatment arms: 1) zimberelimab, 2) zimberelimab + domvanalimab (anti-TIGIT antibody), 3) zimberelimab + domvanalimab + etrumadenant (dual adenosine receptor antagonist). Participants that progress on the zimberelimab monotherapy arm may cross-over to receive the third arm combination of zimberelimab + domvanalimab + etrumadenant.

The primary objective of this clinical study is to evaluate the efficacy of each combination therapy by assessing: 1) objective response rate (ORR) of participants with measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and 2) progression free survival (PFS).

Study Type

Interventional

Enrollment (Actual)

151

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Albury, New South Wales, Australia, 2640
        • Border Medical Oncology
      • Coffs Harbour, New South Wales, Australia, 2450
        • Coffs Harbour Health Campus
      • Nowra, New South Wales, Australia, 2500
        • Shoalhaven Cancer Care Centre
      • Tweed Heads, New South Wales, Australia, 2485
        • Tweed Hospital
    • South Australia
      • Elizabeth Vale, South Australia, Australia, 5112
        • Adelaide Cancer Centre
  • Canada
      • Brampton, Canada, L6R 3J7
        • Brampton Civic Hospital (Bch), William Osler Health Centre
      • Montréal, Canada, H4A 3J1
        • McGill University Health Centre (MUHC) - The Montreal Children's Hospital (MCH)
      • Saint Jerome, Canada, J7Z 5T3
        • Centre Integre de Sante et de Services Sociaux des Laurentides Hopital regional de Saint-Jerome
  • Hong Kong
      • Hong Kong, Hong Kong
        • Princess Margaret Hospital
      • Hong Kong, Hong Kong
        • Hong Kong United Oncology Centre
      • Hong Kong, Hong Kong
        • Humanity and Health Research Center
      • Hong Kong, Hong Kong
        • Queen Elizabeth Hospital (Hong Kong)
  • Korea, Republic of
      • Busan, Korea, Republic of, 49267
        • Kosin University Gospel Hospital
      • Hwasun, Korea, Republic of, 58128
        • Chonnam University Hospital
      • Incheon, Korea, Republic of, 21565
        • Gachon University Gil Medical Center
      • Jeonju, Korea, Republic of, 54907
        • Chonbuk National University Hospital
      • Seongnam-si, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of, 02841
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of, 5505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 03181
        • Kangbuk Samsung Hospital
      • Seoul, Korea, Republic of, 2841
        • Korea University Anam Hospital
      • Suwon-si, Korea, Republic of, 16247
        • St Vincent Hospital of the Catholic University of Korea
      • Uijeongbu, Korea, Republic of, 11765
        • Catholic University of Korea, Uijeongbu St. Mary's Hospital
  • Singapore
      • Singapore, Singapore, 188770
        • Raffles Hospital
      • Singapore, Singapore, 258499
        • Oncocare Cancer Centre
      • Singapore, Singapore, 329563
        • Curie Oncology
  • Taiwan
      • Kaohsiung, Taiwan
        • Chang Gung Memorial Hospital
      • Kaohsiung City, Taiwan, 83301
        • Chang gung memorial hospital, Kaohsiung branch
      • New Taipei, Taiwan, 23561
        • Taipei Medical University - Shuang Ho Hospital
      • Taichung City, Taiwan, 40201
        • Chung Shan Medical University Hospital
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital
      • Tainan City, Taiwan, 736
        • Chi Mei Hospital
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
      • Taipei, Taiwan, 110
        • Taipei Medical University Hospital
      • Taipei City, Taiwan, 114
        • Tri-Service General Hospital
      • Taoyuan, Taiwan, 333
        • Chang Gung Memorial Hospital at Linkou
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • California
      • Anaheim, California, United States, 92801
        • Pacific Cancer Medical Center, Inc
      • Whittier, California, United States, 90603
        • Innovative Clinical Research Institute (ICRI)
    • Florida
      • Englewood, Florida, United States, 34223
        • Florida Cancer Specialists
      • Gainesville, Florida, United States, 32605
        • Florida Cancer Specialists
      • Saint Petersburg, Florida, United States, 33705
        • Florida Cancer Specialists
      • Tallahassee, Florida, United States, 32308
        • Florida Cancer Specialists - Panhandle
      • West Palm Beach, Florida, United States, 33401
        • Florida Cancer Specialists - East
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Baptist Health Lexington
      • Louisville, Kentucky, United States, 40202
        • Norton Cancer Institute
      • Louisville, Kentucky, United States, 40207
        • Baptist Hospital East
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • American Oncology Partners of Maryland, PA
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Detroit Clinical Research Center, PC
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Hattiesburg Clinic
    • Nevada
      • Las Vegas, Nevada, United States, 89196
        • Comprehensive Cancer Centers of Nevada
    • New Jersey
      • Ridgewood, New Jersey, United States, 07450
        • The Valley Hospital - Valley Health System - The Robert and Audrey Luckow Pavilion
    • New York
      • Lake Success, New York, United States, 11042
        • Clinical Research Alliance
      • Lake Success, New York, United States, 11042
        • Northwell Health Cancer Institute
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Health
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Allegheny General Hospital (AGH)-Alleghney Singer Research Institute
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Prisma Health-Upstate
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute
    • Texas
      • Fort Worth, Texas, United States, 76104
        • The Center For Cancer And Blood Disorders (Texas Cancer Care)
      • Kingwood, Texas, United States, 77339
        • Dr.John R Waldron, MD Off of
      • Lubbock, Texas, United States, 79410
        • Joe Arrington Cancer Research and Treatment Center
      • Tyler, Texas, United States, 75701
        • Tyler Hematology-Oncology, P.A.
    • Virginia
      • Blacksburg, Virginia, United States, 24060
        • Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
      • Fairfax, Virginia, United States, 22031
        • Virginia Cancer Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1 (zimberelimab monotherapy)
Participants will receive zimberelimab as an intravenous (IV) infusion.
Drug: Zimberelimab
Zimberelimab is a fully human anti-PD-1 monoclonal antibody
Other Names:
  • AB122
Experimental: Arm 2 (domvanalimab and zimberelimab combination therapy)
Participants will receive domvanalimab IV in combination with zimberelimab IV infusion.
Drug: Zimberelimab
Zimberelimab is a fully human anti-PD-1 monoclonal antibody
Other Names:
  • AB122
Drug: Domvanalimab
Domvanalimab is a humanized monoclonal antibody targeting human TIGIT
Other Names:
  • AB154
Experimental: Arm 3 (domvanalimab, etrumadenant, and zimberelimab combination therapy)
Participants will receive oral etrumadenant in combination with domvanalimab IV and zimberelimab IV infusion
Drug: Etrumadenant
Etrumadenant is an A2aR and A2bR antagonist
Other Names:
  • AB928
Drug: Zimberelimab
Zimberelimab is a fully human anti-PD-1 monoclonal antibody
Other Names:
  • AB122
Drug: Domvanalimab
Domvanalimab is a humanized monoclonal antibody targeting human TIGIT
Other Names:
  • AB154

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: From randomization until death from any cause (up to approximately 3-5 years)
ORR as assessed by RECIST v1.1
From randomization until death from any cause (up to approximately 3-5 years)
Progression-free survival (PFS)
Time Frame: From randomization until death from any cause (up to approximately 3-5 years)
PFS as assessed by RECIST v1.1
From randomization until death from any cause (up to approximately 3-5 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of response (DoR)
Time Frame: 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)
DoR as assessed by RECIST v1.1
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)
Disease control rate (DCR)
Time Frame: 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)
DCR as assessed by RECIST v1.1
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)
Overall Survival (OS)
Time Frame: From randomization to death from any cause (up to approximately 5 years)
OS as assessed at the time of PFS
From randomization to death from any cause (up to approximately 5 years)
Number of Participants with Treatment Emergent Adverse Events (TEAEs)
Time Frame: From Screening until up to 30 days after the last dose (approximately 5 years)
The number and percentage of participants that experience TEAE
From Screening until up to 30 days after the last dose (approximately 5 years)
Pharmacokinetics of zimberelimab
Time Frame: 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)
Serum concentration of zimberelimab as determined by validated assays
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)
Pharmacokinetics of domvanalimab
Time Frame: 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)
Serum concentration of domvanalimab as determined by validated assays
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)
Pharmacokinetics of etrumadenant
Time Frame: 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)
Serum concentration of etrumadenant as determined by validated assays
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)
Immunogenicity of zimberelimab
Time Frame: 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).
Percentage of participants who develop treatment-emergent anti-drug antibodies to zimberelimab
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).
Immunogenicity of domvanalimab
Time Frame: 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).
Percentage of participants who develop treatment-emergent anti-drug antibodies to domvanalimab
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arcus Biosciences, Inc.

Collaborators

Gilead Sciences

Investigators

  • Study Director: Medical Director, Arcus Biosciences, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2020

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

January 23, 2020

First Submitted That Met QC Criteria

February 7, 2020

First Posted (Actual)

February 10, 2020

Study Record Updates

Last Update Posted (Estimated)

November 3, 2023

Last Update Submitted That Met QC Criteria

November 2, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARC-7 (AB154CSP0002)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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