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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02655822
Registration number
NCT02655822
Ethics application status
Date submitted
8/01/2016
Date registered
14/01/2016
Date last updated
30/08/2021
Titles & IDs
Public title
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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Scientific 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
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Secondary ID [1]
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CPI-444-001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Renal Cell Cancer
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Metastatic Castration Resistant Prostate Cancer
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Condition category
Condition code
Cancer
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Prostate
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Cancer
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Kidney
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Ciforadenant
Treatment: Drugs - Ciforadenant
Treatment: Drugs - Ciforadenant
Treatment: Drugs - Ciforadenant + atezolizumab
Treatment: Drugs - Ciforadenant
Experimental: Cohort 1 - Closed - Ciforadenant
Experimental: Cohort 2 - Closed - Ciforadenant
Experimental: Cohort 3 - Closed - Ciforadenant
Experimental: Cohort 4 - Ciforadenant + atezolizumab
Experimental: Cohort 5 - Closed - Ciforadenant
Treatment: Drugs: Ciforadenant
100 mg orally twice daily for the first 14 days of each 28-day cycle.
Treatment: Drugs: Ciforadenant
100 mg orally twice daily for 28 days of each 28-day cycle.
Treatment: Drugs: Ciforadenant
200 mg orally once daily for the first 14 days of each 28-day cycle.
Treatment: Drugs: Ciforadenant + atezolizumab
Ciforadenant 100 mg orally twice daily in combination with atezolizumab intravenously.
Treatment: Drugs: Ciforadenant
Start with 150mg orally twice daily for 28-day cycles; then, increase increments by 100mg/day for 6 dose levels.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of dose-limiting toxicities (DLTs) of ciforadenant as a single agent and in combination with atezolizumab
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Assessment method [1]
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Timepoint [1]
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28 days following first administration of ciforadenant
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Primary outcome [2]
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Objective response rate per RECIST v1.1 criteria of ciforadenant as a single agent and in combination with atezolizumab
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Assessment method [2]
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Timepoint [2]
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From start of treatment to end of treatment, up to 72 months
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Primary outcome [3]
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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
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Assessment method [3]
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Timepoint [3]
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Continuously, up to 72 months
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Primary outcome [4]
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Mean and median Area under the curve (AUC) of ciforadenant
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Assessment method [4]
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Timepoint [4]
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Up to 12 months
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Primary outcome [5]
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Mean and median Maximum concentration (Cmax) of ciforadenant
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Assessment method [5]
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Timepoint [5]
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Up to 12 months
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Primary outcome [6]
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Identify the MDL (maximum dose level) of single agent ciforadenant
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Assessment method [6]
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Timepoint [6]
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From start of treatment to end of treatment, up to 72 months.
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Eligibility
Key inclusion 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2021
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Sample size
Target
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Accrual to date
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Final
502
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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Royal Brisbane and Women's Hospital - Brisbane
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Recruitment hospital [2]
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Monash Health - Clayton
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Recruitment postcode(s) [1]
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4029 - Brisbane
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Recruitment postcode(s) [2]
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3168 - Clayton
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Recruitment outside Australia
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United States of America
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Arizona
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California
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Connecticut
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Florida
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Illinois
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Maryland
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Massachusetts
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Michigan
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New York
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Ohio
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Pennsylvania
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Wisconsin
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Canada
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Alberta
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Canada
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State/province [14]
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British Columbia
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Canada
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State/province [15]
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Ontario
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Corvus Pharmaceuticals, Inc.
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Genentech, Inc.
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Address [1]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02655822
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mehrdad Mobasher, MD, MPH
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Address
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Corvus Pharmaceuticals
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Fax
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02655822
Download to PDF