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

Phase 1/1b Study to Evaluate the Safety and Tolerability of Ciforadenant Alone and in Combination With Atezolizumab in Advanced Cancers

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: NCT02655822
Recruitment Status : Recruiting
First Posted : January 14, 2016
Last Update Posted : September 24, 2020
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Corvus Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE January 8, 2016
First Posted Date  ICMJE January 14, 2016
Last Update Posted Date September 24, 2020
Study Start Date  ICMJE January 2016
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 23, 2019)
  • Incidence of dose-limiting toxicities (DLTs) of ciforadenant as a single agent and in combination with atezolizumab [ Time Frame: 28 days following first administration of ciforadenant ]
  • Objective response rate per RECIST v1.1 criteria of ciforadenant as a single agent and in combination with atezolizumab [ Time Frame: From start of treatment to end of treatment, up to 72 months ]
  • Incidence of treatment-emergent adverse events, as assessed by NCI CTCAE v.4.03, of ciforadenant as a single agent and in combination with atezolizumab [ Time Frame: Continuously, up to 72 months ]
  • Mean and median Area under the curve (AUC) of ciforadenant [ Time Frame: Up to 12 months ]
  • Mean and median Maximum concentration (Cmax) of ciforadenant [ Time Frame: Up to 12 months ]
  • Identify the MDL (maximum dose level) of single agent ciforadenant [ Time Frame: From start of treatment to end of treatment, up to 72 months. ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 13, 2016)
  • Incidence of dose-limiting toxicities (DLTs) of CPI-444 as a single agent and in combination with atezolizumab [ Time Frame: 28 days following first administration of CPI-444 ]
  • Objective response rate per RECIST v1.1 criteria of CPI-444 as a single agent and in combination with atezolizumab [ Time Frame: From start of treatment to end of treatment, up to 24 months ]
  • Incidence of treatment-emergent adverse events, as assessed by NCI CTCAE v.4.03, of CPI-444 as a single agent and in combination with atezolizumab [ Time Frame: Continuously, up to 24 months ]
  • Mean and median Area under the curve (AUC) of CPI-444 [ Time Frame: Day 14 of Cycle 1 ]
  • Mean and median Maximum concentration (Cmax) of CPI-444 [ Time Frame: Day 14 of Cycle 1 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 1/1b Study to Evaluate the Safety and Tolerability of Ciforadenant Alone and in Combination With Atezolizumab in Advanced Cancers
Official Title  ICMJE A Phase 1/1b, Open-Label, Multicenter, Repeat-Dose, Dose-Selection Study of Ciforadenant as Single Agent and in Combination With Atezolizumab in Patients With Selected Incurable Cancers
Brief Summary This is a phase 1/1b open-label, multicenter, dose-selection study of ciforadenant, an oral small molecule targeting the adenosine-A2A receptor on T-lymphocytes and other cells of the immune system. This trial will study the safety, tolerability, and anti-tumor activity of ciforadenant as a single agent and in combination with atezolizumab, a PD-L1 inhibitor against various solid tumors. Ciforadenant blocks adenosine from binding to the A2A receptor. Adenosine suppresses the anti-tumor activity of T cells and other immune cells.
Detailed Description This is a phase 1/1b open-label, multicenter, dose-selection study of ciforadenant, an oral small molecule targeting the adenosine-A2A receptor on T-lymphocytes and other cells of the immune system. This trial will study the safety, tolerability, and anti-tumor activity of ciforadenant as a single agent and in combination with atezolizumab, an intravenous PD-L1 inhibitor. Ciforadenant blocks adenosine from binding to the A2A receptor. Adenosine suppresses the anti-tumor activity of T cells and other immune cells.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Renal Cell Cancer
  • Metastatic Castration Resistant Prostate Cancer
Intervention  ICMJE
  • Drug: Ciforadenant
    100 mg orally twice daily for the first 14 days of each 28-day cycle.
  • Drug: Ciforadenant
    100 mg orally twice daily for 28 days of each 28-day cycle.
  • Drug: Ciforadenant
    200 mg orally once daily for the first 14 days of each 28-day cycle.
  • Drug: Ciforadenant + atezolizumab
    Ciforadenant 100 mg orally twice daily in combination with atezolizumab intravenously.
  • Drug: Ciforadenant
    Start with 150mg orally twice daily for 28-day cycles; then, increase increments by 100mg/day for 6 dose levels.
Study Arms  ICMJE
  • Experimental: Cohort 1 - Closed
    Ciforadenant
    Intervention: Drug: Ciforadenant
  • Experimental: Cohort 2 - Closed
    Ciforadenant
    Intervention: Drug: Ciforadenant
  • Experimental: Cohort 3 - Closed
    Ciforadenant
    Intervention: Drug: Ciforadenant
  • Experimental: Cohort 4
    Ciforadenant + atezolizumab
    Intervention: Drug: Ciforadenant + atezolizumab
  • Experimental: Cohort 5 - Closed
    Ciforadenant
    Intervention: Drug: Ciforadenant
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: December 23, 2019)
336
Original Estimated Enrollment  ICMJE
 (submitted: January 13, 2016)
534
Estimated Study Completion Date  ICMJE October 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Renal Cell Carcinoma Inclusion Criteria

  1. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
  2. Documented pathologic diagnosis of clear cell RCC.
  3. Relapsed or refractory to 1-2 prior lines of therapy containing at least an anti-PD-(L)1 agent.
  4. Measurable disease according to RECIST v1.1
  5. Mandatory newly collected tumor biopsy sample obtained prior to treatment initiation.

Renal Cell Carcinoma Exclusion Criteria

  1. History of severe hypersensitivity reaction to monoclonal antibodies.
  2. Has immunodeficiency or requires treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment or anticipation of need for systemic immunosuppressant medication during study treatment.
  3. Has an active autoimmune disease requiring systemic treatment with in the past 2 years OR a documented history of clinically severe autoimmune disease.

Metastatic Castration-Resistant Prostate Cancer Inclusion Criteria

  1. Documentation of disease: progressive CRPC with histologically or cytologically confirmed adenocarcinoma of the prostate.
  2. Patients must have radiologically evident metastatic disease, but it can be measurable or non-measurable disease:

    • Measurable disease: nodal, visceral, or extra nodal lesions according to RECIST v1.1 using a diagnostic computed tomography
    • Non-measurable disease: bone only disease (up to 1/3 of study population) per PCWG3 criteria
  3. 1-3 prior lines of therapy, including at least one newer generation androgen synthesis inhibitor (e.g., abiraterone) or androgen receptor antagonist (e.g., enzalutamide, apalutamide, darolutamide).
  4. Mandatory newly collected tumor biopsy sample obtained prior to treatment initiation.
  5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.

Metastatic Castration-Resistant Prostate Cancer Exclusion Criteria

  1. Has pure small-cell histology and variants with predominant (≥ 50%) neuroendocrine differentiation.
  2. Has a history of severe hypersensitivity reaction to monoclonal antibodies.
  3. Has immunodeficiency or requires treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment or anticipation of need for systemic immunosuppressant medication during study treatment.
  4. Has an active autoimmune disease requiring systemic treatment with in the past 2 years OR a documented history of clinically severe autoimmune disease.
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: Clinical Operations 650-900-4520 inquiry@corvuspharma.com
Listed Location Countries  ICMJE Australia,   Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02655822
Other Study ID Numbers  ICMJE CPI-444-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Corvus Pharmaceuticals, Inc.
Study Sponsor  ICMJE Corvus Pharmaceuticals, Inc.
Collaborators  ICMJE Genentech, Inc.
Investigators  ICMJE
Study Director: Mehrdad Mobasher, MD, MPH Corvus Pharmaceuticals
PRS Account Corvus Pharmaceuticals, Inc.
Verification Date September 2020

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