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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
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
Secondary ID [1] 0 0
CPI-444-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Cell Cancer 0 0
Metastatic Castration Resistant Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of dose-limiting toxicities (DLTs) of ciforadenant as a single agent and in combination with atezolizumab
Timepoint [1] 0 0
28 days following first administration of ciforadenant
Primary outcome [2] 0 0
Objective response rate per RECIST v1.1 criteria of ciforadenant as a single agent and in combination with atezolizumab
Timepoint [2] 0 0
From start of treatment to end of treatment, up to 72 months
Primary outcome [3] 0 0
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
Timepoint [3] 0 0
Continuously, up to 72 months
Primary outcome [4] 0 0
Mean and median Area under the curve (AUC) of ciforadenant
Timepoint [4] 0 0
Up to 12 months
Primary outcome [5] 0 0
Mean and median Maximum concentration (Cmax) of ciforadenant
Timepoint [5] 0 0
Up to 12 months
Primary outcome [6] 0 0
Identify the MDL (maximum dose level) of single agent ciforadenant
Timepoint [6] 0 0
From start of treatment to end of treatment, up to 72 months.

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2021
Sample size
Target
Accrual to date
Final
502
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [2] 0 0
Monash Health - Clayton
Recruitment postcode(s) [1] 0 0
4029 - Brisbane
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Wisconsin
Country [13] 0 0
Canada
State/province [13] 0 0
Alberta
Country [14] 0 0
Canada
State/province [14] 0 0
British Columbia
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Corvus Pharmaceuticals, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Genentech, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02655822
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mehrdad Mobasher, MD, MPH
Address 0 0
Corvus Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries