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Phase 1/1b Study to Evaluate the Safety and Tolerability of CPI-444 Alone and in Combination With Atezolizumab in Advanced Cancers

This study is currently recruiting participants.
See Contacts and Locations
Verified December 2016 by Corvus Pharmaceuticals, Inc.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Corvus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT02655822
First received: January 8, 2016
Last updated: December 6, 2016
Last verified: December 2016
  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 Intervention Phase
Non-Small Cell Lung Cancer Malignant Melanoma Renal Cell Cancer Triple Negative Breast Cancer Colorectal Cancer Bladder Cancer Drug: CPI-444 Drug: CPI-444 + atezolizumab Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Corvus Pharmaceuticals, Inc.:

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 ]
  • 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 24 months ]
  • 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 24 months ]
  • Mean and median Area under the curve (AUC) of CPI-444 [ Time Frame: Day 14 of Cycle 1 ]
  • Mean and median Maximum concentration (Cmax) of CPI-444 [ Time Frame: Day 14 of Cycle 1 ]

Estimated Enrollment: 534
Study Start Date: January 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: M Fisher inquiry@corvuspharma.com

  Show 33 Study Locations
Sponsors and Collaborators
Corvus Pharmaceuticals, Inc.
Genentech, Inc.
Investigators
Study Director: M Fisher Corvus Pharmaceuticals, Inc.
  More Information

Responsible Party: Corvus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02655822     History of Changes
Other Study ID Numbers: CPI-444-001
Study First Received: January 8, 2016
Last Updated: December 6, 2016

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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Urinary Bladder Neoplasms
Carcinoma, Renal Cell
Triple Negative Breast Neoplasms
Melanoma
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Urologic Neoplasms
Urogenital Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on June 26, 2017