Phase 1/1b Study to Evaluate the Safety and Tolerability of Ciforadenant Alone and in Combination With Atezolizumab in Advanced Cancers
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ClinicalTrials.gov Identifier: NCT02655822 |
Recruitment Status :
Completed
First Posted : January 14, 2016
Last Update Posted : August 30, 2021
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Sponsor:
Corvus Pharmaceuticals, Inc.
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Corvus Pharmaceuticals, Inc.
Tracking Information | ||||
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First Submitted Date ICMJE | January 8, 2016 | |||
First Posted Date ICMJE | January 14, 2016 | |||
Last Update Posted Date | August 30, 2021 | |||
Study Start Date ICMJE | January 2016 | |||
Actual Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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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 |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
502 | |||
Original Estimated Enrollment ICMJE |
534 | |||
Actual Study Completion Date ICMJE | July 2021 | |||
Actual Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Renal Cell Carcinoma Inclusion Criteria
Renal Cell Carcinoma Exclusion Criteria
Metastatic Castration-Resistant Prostate Cancer Inclusion Criteria
Metastatic Castration-Resistant Prostate Cancer Exclusion Criteria
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
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 | |||
Current Responsible Party | Corvus Pharmaceuticals, Inc. | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | Corvus Pharmaceuticals, Inc. | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Genentech, Inc. | |||
Investigators ICMJE |
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PRS Account | Corvus Pharmaceuticals, Inc. | |||
Verification Date | July 2021 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |