Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04262856
Recruitment Status : Recruiting
First Posted : February 10, 2020
Last Update Posted : August 18, 2020
Sponsor:
Information provided by (Responsible Party):
Arcus Biosciences, Inc.

Tracking Information
First Submitted Date  ICMJE January 23, 2020
First Posted Date  ICMJE February 10, 2020
Last Update Posted Date August 18, 2020
Actual Study Start Date  ICMJE May 28, 2020
Estimated Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2020)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2020)
  • Duration of response (DoR) [ Time Frame: 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) ]
    DoR as assessed by RECIST v1.1
  • Disease control rate (DCR) [ Time Frame: 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) ]
    DCR as assessed by RECIST v1.1
  • Adverse Events [ Time Frame: From Screening until up to 100 days after the last dose (approximately 2 years) ]
    The number and percentage of participants that experience an adverse event (AE)
  • Pharmacodynamics of AB122 [ 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). ]
    Plasma concentration of AB122
  • Pharmacodynamics of AB154 [ 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). ]
    Plasma concentration of AB154
  • Pharmacodynamics of AB928 [ 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). ]
    Plasma concentration of AB928
  • Immunogenicity of AB122 [ 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 AB122
  • Immunogenicity of AB154 [ 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 AB154
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate Monotherapy and Combination Immunotherapies in Participants With PD-L1 Positive Non-small Cell Lung Cancer
Official Title  ICMJE 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
Brief Summary This Randomized Phase 2 Open-label Study will Evaluate the Safety and Efficacy of Zimberelimab (AB122) Monotherapy, AB154 in Combination with Zimberelimab, and AB154 in Combination with Zimberelimab and AB928 in Front-line, PD-L1 Positive, Locally Advanced or Metastatic Non-small Cell Lung Cancer.
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 + AB154 (anti-TIGIT antibody), 3) zimberelimab + AB154 + AB928 (dual adenosine receptor antagonist). Participants that progress on the zimberelimab monotherapy arm may cross-over to receive the third arm combination of zimberelimab + AB154 + AB928.

The primary objective of this clinial 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Non Small Cell Lung Cancer
  • Nonsquamous Non Small Cell Lung Cancer
  • Squamous Non Small Cell Lung Cancer
  • Lung Cancer
Intervention  ICMJE
  • Drug: Zimberelimab
    Zimberelimab is a fully human anti-PD-1 monoclononal antibody
    Other Name: AB122
  • Drug: AB154
    AB154 is a humanized monoclonal antibody targeting human TIGIT
  • Drug: AB928
    AB928 is an A2aR and A2bR antagonist
Study Arms  ICMJE
  • Experimental: Arm 1 (Zimberelimab Monotherapy)
    Participants will receive zimberelimab monotherapy by IV infusion.
    Intervention: Drug: Zimberelimab
  • Experimental: Arm 2 (AB154 and Zimberelimab Combination Therapy)
    Participants will receive AB154 in combination with zimberelimab by IV infusion.
    Interventions:
    • Drug: Zimberelimab
    • Drug: AB154
  • Experimental: Arm 3 (AB154, Zimberelimab, and AB928 Combination Therapy)
    Participants will receive oral AB928 in combination with zimberelimab and AB154 by IV infusion
    Interventions:
    • Drug: Zimberelimab
    • Drug: AB154
    • Drug: AB928
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 7, 2020)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 23, 2022
Estimated Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Medical Director 510-694-6220 clinicaltrialinquiry@arcusbio.com
Listed Location Countries  ICMJE Australia,   Hong Kong,   Korea, Republic of,   Singapore,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04262856
Other Study ID Numbers  ICMJE AB154CSP0002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Arcus Biosciences, Inc.
Study Sponsor  ICMJE Arcus Biosciences, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Arcus Biosciences, Inc.
PRS Account Arcus Biosciences, Inc.
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP