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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02655822
Recruitment Status : Completed
First Posted : January 14, 2016
Last Update Posted : August 30, 2021
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Corvus Pharmaceuticals, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Renal Cell Cancer Metastatic Castration Resistant Prostate Cancer Drug: Ciforadenant Drug: Ciforadenant + atezolizumab Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 502 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2016
Actual Primary Completion Date : June 2021
Actual Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1 - Closed
Ciforadenant
 Drug: Ciforadenant
100 mg orally twice daily for the first 14 days of each 28-day cycle.
Experimental: Cohort 2 - Closed
Ciforadenant
 Drug: Ciforadenant
100 mg orally twice daily for 28 days of each 28-day cycle.
Experimental: Cohort 3 - Closed
Ciforadenant
 Drug: Ciforadenant
200 mg orally once daily for the first 14 days of each 28-day cycle.
Experimental: Cohort 4
Ciforadenant + atezolizumab
 Drug: Ciforadenant + atezolizumab
Ciforadenant 100 mg orally twice daily in combination with atezolizumab intravenously.
Experimental: Cohort 5 - Closed
Ciforadenant
 Drug: Ciforadenant
Start with 150mg orally twice daily for 28-day cycles; then, increase increments by 100mg/day for 6 dose levels.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. Mean and median Area under the curve (AUC) of ciforadenant [ Time Frame: Up to 12 months ]
  5. Mean and median Maximum concentration (Cmax) of ciforadenant [ Time Frame: Up to 12 months ]
  6. Identify the MDL (maximum dose level) of single agent ciforadenant [ Time Frame: From start of treatment to end of treatment, up to 72 months. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02655822


Locations
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Sponsors and Collaborators
Corvus Pharmaceuticals, Inc.
Genentech, Inc.
Investigators
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Study Director: Mehrdad Mobasher, MD, MPH Corvus Pharmaceuticals
More Information
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Responsible Party: Corvus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02655822    
Other Study ID Numbers: CPI-444-001
First Posted: January 14, 2016    Key Record Dates
Last Update Posted: August 30, 2021
Last Verified: July 2021
Keywords provided by Corvus Pharmaceuticals, Inc.:
RCC
Kidney Cancer
mCRPC
Prostate Cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Carcinoma, Renal Cell
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases
Adenocarcinoma
Carcinoma
 Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Kidney Diseases
Urologic Diseases
Atezolizumab
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Antineoplastic Agents