Clinical Trial - NCT02655822

Phase 1/1b Study to Evaluate the Safety and Tolerability of CPI-444 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


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Purpose

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.
Condition Title Intervention Phase
Non-Small Cell Lung Cancer Malignant Melanoma Renal Cell Cancer Triple Negative Breast Cancer Colorectal Cancer Bladder Cancer Metastatic Castration Resistant Prostate Cancer CPI-444 CPI-444 CPI-444 CPI-444 + atezolizumab CPI-444 Phase 1
Study Type Interventional
Official Title 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

Primary Outcome Measures

Incidence of dose-limiting toxicities (DLTs) of CPI-444 as a single agent and in combination with atezolizumab [Time Frame: 28 days following first administration of CPI-444] [Designated as safety issue: ]

Objective response rate per RECIST v1.1 criteria of CPI-444 as a single agent and in combination with atezolizumab [Time Frame: From start of treatment to end of treatment, up to 36 months] [Designated as safety issue: ]

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 [Time Frame: Continuously, up to 36 months] [Designated as safety issue: ]

Mean and median Area under the curve (AUC) of CPI-444 [Time Frame: Day 14 of Cycle 1] [Designated as safety issue: ]

Mean and median Maximum concentration (Cmax) of CPI-444 [Time Frame: Day 14 of Cycle 1] [Designated as safety issue: ]

Identify the MDL (maximum dose level) of single agent CPI-444 [Time Frame: From start of treatment to end of treatment, up to 36 months.] [Designated as safety issue: ]


Secondary Outcome Measures

Estimated Enrollment: 323
Study Start Date: January 2016
Estimated Study Completion Date: October 2021
Estimated Primary Completion Date: June 2021
Arms Assigned Interventions

Experimental:Cohort 1

CPI-444
Drug:CPI-444
100 mg orally twice daily for the first 14 days of each 28-day cycle.

Experimental:Cohort 2

CPI-444
Drug:CPI-444
100 mg orally twice daily for 28 days of each 28-day cycle.

Experimental:Cohort 3

CPI-444
Drug:CPI-444
200 mg orally once daily for the first 14 days of each 28-day cycle.

Experimental:Cohort 4

CPI-444 + atezolizumab
Drug:CPI-444 + atezolizumab
CPI-444 orally in combination with atezolizumab intravenously.

Experimental:Cohort 5

CPI-444
Drug:CPI-444
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

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), bladder cancer, and metastatic castration resistant prostate 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.

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
    • UCLA Medical Center Los Angeles, California, United States, 90095
    • University of California - San Francisco San Francisco, California, United States, 94143
    • Stanford Cancer Institute Stanford, California, United States, 94305
  • United States, Colorado
    • University of Colorado Cancer Center Aurora, Colorado, United States, 80045
  • United States, Connecticut
    • Yale University New Haven, Connecticut, United States, 06510
  • United States, District of Columbia
    • Georgetown University Washington, District of Columbia, United States, 20057
  • United States, Georgia
    • Winship Cancer Institute of Emory University Atlanta, Georgia, United States, 30322
  • 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, Missouri
    • Washington University School of Medicine Saint Louis, Missouri, United States, 63110
  • United States, Nebraska
    • University of Nebraska Medical Center Omaha, Nebraska, United States, 68154
  • United States, New York
    • Roswell Park Cancer Institute Buffalo, New York, United States, 14263
    • Icahn School of Medicine at Mount Sinai New York, New York, United States, 10029
    • Columbia University Medical Center New York, New York, United States, 10032
    • Memorial Sloan Kettering Cancer Center New York, New York, United States, 10065
  • United States, North Carolina
    • Carolina BioOncology Institute Huntersville, North Carolina, United States, 28078
  • United States, Ohio
    • Cleveland Clinic Cleveland, Ohio, United States, 44195
    • The Ohio State University Wexner Medical Center Columbus, Ohio, United States, 43210
  • United States, Pennsylvania
    • University of Pittsburgh Medical Center Cancer Center Pittsburgh, Pennsylvania, United States, 15232
  • United States, Texas
    • Mary Crowley Cancer Research Centers Dallas, Texas, United States, 75251
    • University of Texas Southwestern Medical Center Dallas, Texas, United States, 75390
  • 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.:

NSCLC

MEL

RCC

TNBC

Triple Negative Breast Neoplasms

Neoplasms

CRC

Lung Cancer

Kidney Cancer

Colon Cancer

Rectal Cancer

Skin Cancer

Breast Cancer

mCRPC

Prostate Cancer

Additional relevant MeSH terms:

Prostatic Neoplasms

Carcinoma, Non-Small-Cell Lung

Colorectal Neoplasms

Urinary Bladder Neoplasms

Triple Negative Breast Neoplasms

Carcinoma, Renal Cell

Melanoma

Atezolizumab

Antibodies, Monoclonal

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 May 30, 2019