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Renal Cell CancerPhase 1NCT02655822

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

A Phase 1 study testing Ciforadenant and Ciforadenant + atezolizumab in people with Renal Cell Cancer and Metastatic Castration Resistant Prostate Cancer, run by Corvus Pharmaceuticals, Inc. at 20 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ciforadenant and Ciforadenant + atezolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
502 participants
Where
20 sitesin 3 countries
Study dates
Jan 2016to Jul 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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
  1. 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).
  2. Mandatory newly collected tumor biopsy sample obtained prior to treatment initiation.
  3. 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.

Trial locations and contacts

20 sites in 3 countries.

20 sites in 3 countries

United States15 sites

  • Sidney Kimmel Comprehensive Cancer Center - Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21287

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • University of Miami Hospital and Clinics

    Miami, Florida, 33136

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Yale University

    New Haven, Connecticut, 06510

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • University of Pittsburgh Medical Center Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • University of California - San Francisco

    San Francisco, California, 94143

  • Stanford Cancer Institute

    Stanford, California, 94305

  • University of Arizona Cancer Center

    Tucson, Arizona, 85719

Other trials in United States

Canada3 sites

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario, K1H 8L6

  • British Columbia Cancer Agency - Vancouver Centre

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Australia2 sites

  • Royal Brisbane and Women's Hospital

    Brisbane, Queensland, 4029

  • Monash Health

    Clayton, Victoria, 3168

Other trials in Australia

About this study

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

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.

Read the 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.

Being tested
Ciforadenant, Ciforadenant + atezolizumab
Keywords
RCC, Kidney Cancer, mCRPC, Prostate Cancer
Medical subject headings
Carcinoma, Renal Cell, Kidney Neoplasms, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CiforadenantDrug

    100 mg orally twice daily for the first 14 days of each 28-day cycle.

  • CiforadenantDrug

    100 mg orally twice daily for 28 days of each 28-day cycle.

  • CiforadenantDrug

    200 mg orally once daily for the first 14 days of each 28-day cycle.

  • Ciforadenant + atezolizumabDrug

    Ciforadenant 100 mg orally twice daily in combination with atezolizumab intravenously.

  • CiforadenantDrug

    Start with 150mg orally twice daily for 28-day cycles; then, increase increments by 100mg/day for 6 dose levels.

Study groups in NCT02655822
Study groupRoleWhat they receive
Cohort 1 - ClosedExperimentalCiforadenant
Receives: Drug: Ciforadenant
Cohort 2 - ClosedExperimentalCiforadenant
Receives: Drug: Ciforadenant
Cohort 3 - ClosedExperimentalCiforadenant
Receives: Drug: Ciforadenant
Cohort 4ExperimentalCiforadenant + atezolizumab
Receives: Drug: Ciforadenant + atezolizumab
Cohort 5 - ClosedExperimentalCiforadenant
Receives: Drug: Ciforadenant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of dose-limiting toxicities (DLTs) of ciforadenant as a single agent and in combination with atezolizumab

    Measured: 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

    Measured: 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

    Measured: Continuously, up to 72 months

  4. Mean and median Area under the curve (AUC) of ciforadenant

    Measured: Up to 12 months

  5. Mean and median Maximum concentration (Cmax) of ciforadenant

    Measured: Up to 12 months

  6. Identify the MDL (maximum dose level) of single agent ciforadenant

    Measured: From start of treatment to end of treatment, up to 72 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2016 (estimated)
  2. Study startJan 2016
  3. Primary completionJun 2021
  4. Study completionJul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
502 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02655822
Sponsor's protocol ID
CPI-444-001
Status last verified
Jul 2021
First submitted
8 Jan 2016
Last updated
30 Aug 2021
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ciforadenant and Ciforadenant + atezolizumab in people with Renal Cell Cancer and Metastatic Castration Resistant Prostate Cancer, run by Corvus Pharmaceuticals, Inc. at 20 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States, Canada, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02655822.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2021.

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