Clinical Trial - NCT02655822

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

Recruiting

Sponsor: Corvus Pharmaceuticals, Inc.

Collaborators: Genentech, Inc.

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT02655822

Protocol Info

Short Description: Phase 1/1b CPI-444 With or Without Atezolizumab in Incurable Cancers
Long Description: Phase 1/1b, Open-Label, Multicenter, Repeat-Dose, Dose-Selection Study of CPI-444 as Single Agent and in Combination with Atezolizumab in Patients with Selected Incurable Cancers
MGH Status: Open
Sponsor: Corvus Pharmaceuticals, Inc.
Disease Program: Phase I

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.




Purpose

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 Title Intervention Phase
Renal Cell Cancer Metastatic Castration Resistant Prostate Cancer Ciforadenant Ciforadenant Ciforadenant Ciforadenant + atezolizumab Ciforadenant Phase 1
Study Type Interventional
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

Primary Outcome Measures

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] [Designated as safety issue: ]

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] [Designated as safety issue: ]

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] [Designated as safety issue: ]

Mean and median Area under the curve (AUC) of ciforadenant [Time Frame: Up to 12 months] [Designated as safety issue: ]

Mean and median Maximum concentration (Cmax) of ciforadenant [Time Frame: Up to 12 months] [Designated as safety issue: ]

Identify the MDL (maximum dose level) of single agent ciforadenant [Time Frame: From start of treatment to end of treatment, up to 72 months.] [Designated as safety issue: ]


Secondary Outcome Measures

Estimated Enrollment: 336
Study Start Date: January 2016
Estimated Study Completion Date: October 2021
Estimated Primary Completion Date: June 2021
Arms Assigned Interventions

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.

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: All

Accepts Healthly Volunteers: No

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT02655822

Locations

  • United States, Arizona
    • University of Arizona Cancer Center Tucson, Arizona, United States, 85719
  • United States, California
    • University of California - San Francisco San Francisco, California, United States, 94143
    • Stanford Cancer Institute Stanford, California, United States, 94305
  • United States, Connecticut
    • Yale University New Haven, Connecticut, United States, 06510
  • United States, Florida
    • University of Miami Hospital and Clinics Miami, Florida, United States, 33136
  • United States, Illinois
    • Rush University Medical Center Chicago, Illinois, United States, 60612
    • University of Chicago Medical Center Chicago, Illinois, United States, 60637
  • United States, Maryland
    • Sidney Kimmel Comprehensive Cancer Center - Johns Hopkins University School of Medicine Baltimore, Maryland, United States, 21287
  • United States, Massachusetts
    • Massachusetts General Hospital Boston, Massachusetts, United States, 02114
  • United States, Michigan
    • Karmanos Cancer Institute Detroit, Michigan, United States, 48201
  • United States, New York
    • Roswell Park Cancer Institute Buffalo, New York, United States, 14263
    • Memorial Sloan Kettering Cancer Center New York, New York, United States, 10065
  • United States, Ohio
    • Cleveland Clinic Cleveland, Ohio, United States, 44195
  • United States, Pennsylvania
    • University of Pittsburgh Medical Center Cancer Center Pittsburgh, Pennsylvania, United States, 15232
  • United States, Wisconsin
    • Medical College of Wisconsin Milwaukee, Wisconsin, United States, 53226
  • Australia, Queensland
    • Royal Brisbane and Women's Hospital Brisbane, Queensland, Australia, 4029
  • Australia, Victoria
    • Monash Health Clayton, Victoria, Australia, 3168
  • Canada, Alberta
    • Cross Cancer Institute Edmonton, Alberta, Canada, T6G 1Z2
  • Canada, British Columbia
    • British Columbia Cancer Agency - Vancouver Centre Vancouver, British Columbia, Canada, V5Z 4E6
  • Canada, Ontario
    • The Ottawa Hospital Cancer Centre Ottawa, Ontario, Canada, K1H 8L6

Sponsors and Collaborators

Corvus Pharmaceuticals, Inc.

Genentech, Inc.

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT02655822
Other Study ID Numbers:
Study First Received:
Last Updated:
Health Authority:

Keywords provided by Corvus Pharmaceuticals, Inc.:

RCC

Kidney Cancer

mCRPC

Prostate Cancer

Additional relevant MeSH terms:

Prostatic Neoplasms

Carcinoma, Renal Cell

Atezolizumab

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on October 14, 2020