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BRIEF TITLE: Study of CPI-444 as Single Agent and in Combination With Atezolizumab in Patients With Selected Incurable Cancers

A 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


  • Org Study ID: CPI-444-001
  • Secondary ID:
  • NCT ID: NCT02655822
  • NCT Alias:
  • Sponsor: Corvus Pharmaceuticals, Inc. - Industry
  • Source: Corvus Pharmaceuticals, Inc.

Brief Summary

This is a phase 1/1b open-label, multicenter, dose-selection study of CPI-444, 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 CPI-444 as a single agent and in combination with atezolizumab, a PD-L1 inhibitor against various solid tumors. CPI-444 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 CPI-444, 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 CPI-444 as
a single agent and in combination with atezolizumab, an intravenous PD-L1 inhibitor. CPI-444
blocks adenosine from binding to the A2A receptor. Adenosine suppresses the anti-tumor
activity of T cells and other immune cells.

Overal Status Start Date Phase Study Type
Recruiting Start Date: January 2016 Phase 1 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Incidence of dose-limiting toxicities (DLTs) of CPI-444 as a single agent and in combination with atezolizumab

Primary Outcome 1 - Time Frame: 28 days following first administration of CPI-444

Primary Outcome 2 - Measure: Objective response rate per RECIST v1.1 criteria of CPI-444 as a single agent and in combination with atezolizumab

Primary Outcome 2 - Time Frame: From start of treatment to end of treatment, up to 24 months

Primary Outcome 3 - Measure: Incidence of treatment-emergent adverse events, as assessed by NCI CTCAE v.4.03, of CPI-444 as a single agent and in combination with atezolizumab

Primary Outcome 3 - Time Frame: Continuously, up to 24 months

Primary Outcome 4 - Measure: Mean and median Area under the curve (AUC) of CPI-444

Primary Outcome 4 - Time Frame: Day 14 of Cycle 1

Primary Outcome 5 - Measure: Mean and median Maximum concentration (Cmax) of CPI-444

Primary Outcome 5 - Time Frame: Day 14 of Cycle 1

Condition:

  • Non-Small Cell Lung Cancer
  • Malignant Melanoma
  • Renal Cell Cancer
  • Triple Negative Breast Cancer
  • Colorectal Cancer
  • Bladder Cancer

Eligibility

Criteria:
Inclusion Criteria

1. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.

2. Documented incurable cancer with one of the following histologies: non-small cell lung
cancer, malignant melanoma, renal cell cancer, triple negative breast cancer,
colorectal cancer with microsatellite instability (MSI), and bladder cancer.

3. At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST
1.1).

4. At least 1 but not more than 5 prior systemic therapies for advanced/recurrent or
progressing disease.

Exclusion Criteria

1. History of severe hypersensitivity reaction to monoclonal antibodies.

2. Any active autoimmune disease or a documented history of serious autoimmune disease
within the past 5 years requiring immunosuppressive therapy.

3. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced
pneumonitis, idiopathic pneumonitis, or clinical symptoms of active pneumonitis.

4. The use of any investigational medication or device in the 30 days prior to screening
and throughout the study is prohibited.

5. If a patient is currently receiving denosumab, this must be discontinued prior to
enrollment. Substitution with biphosphonates are acceptable.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: M Fisher

Role: Study Director

Affiliation: Corvus Pharmaceuticals, Inc.

Overall Contact

Name: M Fisher

Phone:

Email: inquiry@corvuspharma.com

Locations

Facility Status Contact
University of Arizona Cancer Center
Tucson, Arizona 85719
United States
Recruiting
UCLA Medical Center
Los Angeles, California 90095
United States
Recruiting
University of California - San Francisco
San Francisco, California 94143
United States
Recruiting
Stanford Cancer Institute
Stanford, California 94305
United States
Recruiting
University of Colorado Cancer Center
Aurora, Colorado 80045
United States
Recruiting
Yale University
New Haven, Connecticut 06510
United States
Recruiting
Georgetown University
Washington, District of Columbia 20057
United States
Recruiting
Winship Cancer Institute of Emory University
Atlanta, Georgia 30322
United States
Recruiting
Rush University Medical Center
Chicago, Illinois 60612
United States
Recruiting
University of Chicago Medical Center
Chicago, Illinois 60637
United States
Recruiting
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana 46202
United States
Recruiting
Sidney Kimmel Comprehensive Cancer Center - Johns Hopkins University School of Medicine
Baltimore, Maryland 21287
United States
Recruiting
Karmanos Cancer Institute
Detroit, Michigan 48201
United States
Recruiting
Washington University School of Medicine
St. Louis, Missouri 63110
United States
Recruiting
University of Nebraska Medical Center
Omaha, Nebraska 68154
United States
Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York 10029
United States
Recruiting
Columbia University Medical Center
New York, New York 10032
United States
Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Recruiting
Carolina BioOncology Institute
Huntersville, North Carolina 28078
United States
Recruiting Ashley McClain
704-947-6599
Cleveland Clinic
Cleveland, Ohio 44195
United States
Recruiting
University of Pittsburgh Medical Center Cancer Center
Pittsburgh, Pennsylvania 15232
United States
Recruiting
Mary Crowley Cancer Research Centers
Dallas, Texas 75251
United States
Recruiting
University of Washington, Seattle Cancer Care Alliance
Seattle, Washington 98109
United States
Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States
Recruiting
Chris O'Brien Lifehouse
Camperdown, New South Wales 2050
Australia
Recruiting
Royal Brisbane and Women's Hospital
Brisbane, Queensland 4029
Australia
Recruiting
Monash Health
Clayton, Victoria 3168
Australia
Recruiting
Cabrini Hospital Malvern
Malvern, Victoria 3144
Australia
Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria 3000
Australia
Recruiting
Cross Cancer Institute
Edmonton, Alberta T6G 1Z2
Canada
Recruiting
British Columbia Cancer Agency - Vancouver Centre
Vancouver, British Columbia V5Z 4E6
Canada
Recruiting
Juravinski Cancer Centre
Hamilton, Ontario L8V 5C2
Canada
Recruiting
The Ottawa Hospital Cancer Centre
Ottawa, Ontario K1H 8L6
Canada
Recruiting