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

Sponsor
Arcus Biosciences, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04262856
Collaborator
(none)
150
Enrollment
72
Locations
3
Arms
32.2
Anticipated Duration (Months)
2.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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, metastatic non-small cell lung cancer.

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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
Actual Study Start Date :
May 28, 2020
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

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, zimberelimab, and etrumadenant combination therapy)

    Participants will receive oral etrumadenant in combination with zimberelimab IV and domvanalimab 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

    • Drug: Etrumadenant
    Etrumadenant is an A2aR and A2bR antagonist
    Other Names:
  • AB928

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Objective response rate (ORR) [From randomization until death from any cause (up to approximately 3-5 years)]

      ORR as assessed by RECIST v1.1

    2. Progression-free survival (PFS) [From randomization until death from any cause (up to approximately 3-5 years)]

      PFS as assessed by RECIST v1.1

    Secondary Outcome Measures

    1. Duration of response (DoR) [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

    2. Disease control rate (DCR) [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

    3. Overall Survival (OS) [From randomization to death from any cause (up to approximately 5 years)]

      OS as assessed at the time of PFS

    4. Number of Participants with Treatment Emergent Adverse Events (TEAEs) [From Screening until up to 30 days after the last dose (approximately 5 years)]

      The number and percentage of participants that experience TEAE

    5. Pharmacokinetics of zimberelimab [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

    6. Pharmacokinetics of domvanalimab [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

    7. Pharmacokinetics of etrumadenant [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

    8. Immunogenicity of 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).]

      Percentage of participants who develop treatment-emergent anti-drug antibodies to zimberelimab

    9. Immunogenicity of 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).]

      Percentage of participants who develop treatment-emergent anti-drug antibodies to domvanalimab

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Birmingham Alabama United States 35294
    2 Pacific Cancer Medical Center, Inc Anaheim California United States 92801
    3 Irvine Neuropsychiatric Center-University of California Orange California United States 92868
    4 Redlands Community Hospital Redlands California United States 92373
    5 St. Joseph Heritage Healthcare Santa Rosa California United States 95403
    6 Innovative Clinical Research Institute (ICRI) Whittier California United States 90603
    7 Florida Cancer Specialists Englewood Florida United States 34223
    8 Florida Cancer Specialists Gainesville Florida United States 32605
    9 Florida Cancer Specialists Saint Petersburg Florida United States 33705
    10 Florida Cancer Specialists - Panhandle Tallahassee Florida United States 32308
    11 Florida Cancer Specialists - East West Palm Beach Florida United States 33401
    12 Joliet Oncology-Hematology Associates, Ltd. Joliet Illinois United States 60435
    13 Baptist Health Lexington Lexington Kentucky United States 40503
    14 Norton Cancer Institute Louisville Kentucky United States 40202
    15 Baptist Hospital East Louisville Kentucky United States 40207
    16 Ochsner Clinic Foundation New Orleans Louisiana United States 70121
    17 Frederick Memorial Hospital Frederick Maryland United States 21702
    18 Detroit Clinical Research Center, PC Farmington Hills Michigan United States 48334
    19 Hattiesburg Clinic Hattiesburg Mississippi United States 39401
    20 HCA Midwest Healthcare Kansas City Missouri United States 64132
    21 The Valley Hospital - Valley Health System - The Robert and Audrey Luckow Pavilion Ridgewood New Jersey United States 07450
    22 Clinical Research Alliance Lake Success New York United States 11042
    23 Northwell Health Cancer Institute Lake Success New York United States 11042
    24 Columbia University Medical Center New York New York United States 10032
    25 Wake Forest Baptist Health Winston-Salem North Carolina United States 27157
    26 Toledo Clinic Cancer Center - Toledo Toledo Ohio United States 43623
    27 Allegheny General Hospital (AGH)-Alleghney Singer Research Institute Pittsburgh Pennsylvania United States 15224
    28 Guthrie Medical Group, PC Sayre Pennsylvania United States 18840
    29 Sarah Cannon Research Institute Nashville Tennessee United States 37203
    30 The Center For Cancer And Blood Disorders (Texas Cancer Care) Fort Worth Texas United States 76104
    31 Dr.John R Waldron, MD Off of Kingwood Texas United States 77339
    32 Joe Arrington Cancer Research and Treatment Center Lubbock Texas United States 79410
    33 Tyler Hematology-Oncology, P.A. Tyler Texas United States 75701
    34 Oncology and Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care Blacksburg Virginia United States 24060
    35 Virginia Cancer Specialists Fairfax Virginia United States 22031
    36 Medical Oncology Associates dba Summit Cancer Centers Spokane Washington United States 99208
    37 Border Medical Oncology Albury New South Wales Australia 2640
    38 Coffs Harbour Health Campus Coffs Harbour New South Wales Australia 2450
    39 Shoalhaven Cancer Care Centre Nowra New South Wales Australia 2500
    40 Tweed Hospital Tweed Heads New South Wales Australia 2485
    41 Adelaide Cancer Centre Elizabeth Vale South Australia Australia 5112
    42 Brampton Civic Hospital (Bch), William Osler Health Centre Brampton Canada L6R 3J7
    43 McGill University Health Centre (MUHC) - The Montreal Children's Hospital (MCH) Montréal Canada H4A 3J1
    44 Centre Integre de Sante et de Services Sociaux des Laurentides Hopital regional de Saint-Jerome Saint Jerome Canada J7Z 5T3
    45 Hong Kong United Oncology Centre Hong Kong Hong Kong
    46 Humanity and Health Research Center Hong Kong Hong Kong
    47 Princess Margaret Hospital Hong Kong Hong Kong
    48 Queen Elizabeth Hospital (Hong Kong) Hong Kong Hong Kong
    49 Kosin University Gospel Hospital Busan Korea, Republic of 49267
    50 Chonnam University Hospital Hwasun Korea, Republic of 58128
    51 Gachon University Gil Medical Center Incheon Korea, Republic of 21565
    52 Chonbuk National University Hospital Jeonju Korea, Republic of 54907
    53 Seoul National University Bundang Hospital Seongnam-si Korea, Republic of 13620
    54 Korea University Anam Hospital Seoul Korea, Republic of 02841
    55 Kangbuk Samsung Hospital Seoul Korea, Republic of 03181
    56 Korea University Anam Hospital Seoul Korea, Republic of 2841
    57 Asan Medical Center Seoul Korea, Republic of 5505
    58 Seoul St. Mary's Hospital, The Catholic University of Korea Seoul Korea, Republic of 6591
    59 St Vincent Hospital of the Catholic University of Korea Suwon-si Korea, Republic of 16247
    60 Catholic University of Korea, Uijeongbu St. Mary's Hospital Uijeongbu Korea, Republic of 11765
    61 Raffles Hospital Singapore Singapore 188770
    62 Oncocare Cancer Centre Singapore Singapore 258499
    63 Curie Oncology Singapore Singapore 329563
    64 Chang Gung Memorial Hospital, Kaohsiung Branch Kaohsiung City Taiwan 83301
    65 Taipei Medical University - Shuang Ho Hospital New Taipei Taiwan 23561
    66 Chung Shan Medical University Hospital Taichung City Taiwan 40201
    67 Chi Mei Hospital Tainan City Taiwan 736
    68 National Cheng Kung University Hospital Tainan Taiwan 704
    69 Tri-Service General Hospital Taipei City Taiwan 114
    70 National Taiwan University Hospital Taipei Taiwan 10002
    71 Taipei Medical University Hospital Taipei Taiwan 110
    72 Chang Gung Memorial Hospital at Linkou Taoyuan Taiwan 333

    Sponsors and Collaborators

    • Arcus Biosciences, Inc.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Arcus Biosciences, Inc.
    ClinicalTrials.gov Identifier:
    NCT04262856
    Other Study ID Numbers:
    • AB154CSP0002
    First Posted:
    Feb 10, 2020
    Last Update Posted:
    Apr 15, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Arcus Biosciences, Inc.
    Non Small Cell Lung Cancer
    Lung Cancer
    NSCLC
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung

    Study Results

    No Results Posted as of Apr 15, 2022