CPI-006 Alone and in Combination With Ciforadenant and With Pembrolizumab for Patients With Advanced Cancers
NCT ID: NCT03454451
Last Updated: 2023-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
117 participants
INTERVENTIONAL
2018-04-25
2023-02-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort 1a
CPI-006
CPI-006
Subjects will receive escalating doses of CPI-006 administered intravenously once every 21 days until MTD is reached or until disease progression.
Cohort1b
CPI-006 + ciforadenant
CPI-006 + ciforadenant
Subjects will receive escalating doses of CPI-006 administered intravenously once every 21 days in combination with CPI-444 orally twice daily until MTD is reached for CPI-006 or until disease progression.
Cohort 1c
CPI-006 + pembrolizumab
CPI-006 + pembrolizumab
Subjects will receive escalating doses of CPI-006 in combination with pembrolizumab administered intravenously once every 21 days until MTD is reached for CPI-006 or until disease progression.
Cohort 2a
CPI-006
CPI-006
Selected dose of CPI-006 administered intravenously once every 21 days until disease progression.
Cohort 2b
CPI-006 + ciforadenant
CPI-006 + ciforadenant
Selected dose of CPI-006 administered intravenously once every 21 days, in combination with CPI-444 orally twice daily until disease progression.
Cohort 2c
CPI-006 + pembrolizumab
CPI-006 + pembrolizumab
Selected dose of CPI-006 in combination with pembrolizumab administered intravenously once every 21 days until disease progression.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CPI-006
Subjects will receive escalating doses of CPI-006 administered intravenously once every 21 days until MTD is reached or until disease progression.
CPI-006 + ciforadenant
Subjects will receive escalating doses of CPI-006 administered intravenously once every 21 days in combination with CPI-444 orally twice daily until MTD is reached for CPI-006 or until disease progression.
CPI-006 + pembrolizumab
Subjects will receive escalating doses of CPI-006 in combination with pembrolizumab administered intravenously once every 21 days until MTD is reached for CPI-006 or until disease progression.
CPI-006
Selected dose of CPI-006 administered intravenously once every 21 days until disease progression.
CPI-006 + ciforadenant
Selected dose of CPI-006 administered intravenously once every 21 days, in combination with CPI-444 orally twice daily until disease progression.
CPI-006 + pembrolizumab
Selected dose of CPI-006 in combination with pembrolizumab administered intravenously once every 21 days until disease progression.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Documented incurable cancer with one of the following histologies: nonsmall cell lung cancer, renal cell cancer, triple negative breast cancer, colorectal cancer with microsatellite instability(MSI), bladder cancer, cervical cancer, uterine cancer, sarcoma, endometrial cancer, and metastatic castration resistant prostate cancer.
3. At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST 1.1).
4. For Escalation: At least 1 but not more than 5 prior systemic therapies for advanced/ recurrent or progressing disease. For Expansion: Subject must have progressed on, be refractory to, or intolerant to 1-3 prior systemic therapies.
5. Willingness to provide tumor biopsies.
Exclusion Criteria
2. Subjects who have received prior therapy with regimens containing cytotoxicT-lymphocyte antigen-4 (CTLA-4), programmed cell death ligand 1 (PDL1), or PD1 antagonists are NOT permitted to enroll unless all adverse events (AEs) while receiving prior immunotherapy have resolved to Grade 1 or baseline prior to screening.
3. History of (non-infectious) pneumonitis that required steroids or subject has current pneumonitis.
4. The use of any investigational medication or device in the 30 days prior to screening and throughout the study is prohibited.
5. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Corvus Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
S Mahabhashyam, MD
Role: STUDY_CHAIR
Corvus Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Arizona Oncology
Tucson, Arizona, United States
City Of Hope
Duarte, California, United States
UC San Francisco
San Francisco, California, United States
Yale School of Medicine
New Haven, Connecticut, United States
University of Miami
Miami, Florida, United States
Northwestern University
Chicago, Illinois, United States
The University of Chicago
Chicago, Illinois, United States
The John Hopkins University
Baltimore, Maryland, United States
Dana Farber
Boston, Massachusetts, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
NY Hematology
Albany, New York, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Carolina BioOncology Institute
Huntsville, North Carolina, United States
Oncology Hematology Care
Cincinnati, Ohio, United States
University of Oklahoma - Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
UPMC Hillman
Pittsburgh, Pennsylvania, United States
Greenville
Greenville, South Carolina, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Mary Crowley Cancer Research
Dallas, Texas, United States
Virginia Cancer
Fairfax, Virginia, United States
Froedtert Hospital & Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Lifehouse
Camperdown, New South Wales, Australia
St. Vincent's Hospital
Darlinghurst, New South Wales, Australia
Westmead
Westmead, New South Wales, Australia
Royal Brisbane
Herston, Queensland, Australia
Monash Hospital
Clayton, Victoria, Australia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Miller RA, Luke JJ, Hu S, Mahabhashyam S, Jones WB, Marron T, Merchan JR, Hughes BGM, Willingham SB. Anti-CD73 antibody activates human B cells, enhances humoral responses and induces redistribution of B cells in patients with cancer. J Immunother Cancer. 2022 Dec;10(12):e005802. doi: 10.1136/jitc-2022-005802.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CPI-006-001
Identifier Type: -
Identifier Source: org_study_id