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CPI-006 Alone and in Combination With Ciforadenant and With Pembrolizumab for Patients With Advanced Cancers

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ClinicalTrials.gov Identifier: NCT03454451
Recruitment Status : Recruiting
First Posted : March 6, 2018
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Corvus Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE February 5, 2018
First Posted Date  ICMJE March 6, 2018
Last Update Posted Date February 17, 2020
Actual Study Start Date  ICMJE April 25, 2018
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 16, 2020)
  • Incidence of dose-limiting toxicities (DLTs) of CPI-006 as a single agent and in combination with ciforadenant and with pembrolizumab. [ Time Frame: From start of treatment to end of treatment, up to 36 months ]
  • Incidence of treatment-emergent adverse events as assessed by NCI CTCAE v.4.03, of CPI-006 as single agent and in combination with ciforadenant and with pembrolizumab. [ Time Frame: From start of treatment to end of treatment, up to 36 months ]
  • Identify the MDL(maximum dose level) of single agent CPI-006 [ Time Frame: From start of treatment to end of treatment, up to 36 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 2, 2018)
  • Incidence of dose-limiting toxicities (DLTs) of CPI-006 as a single agent and in combination with CPI-444 and with pembrolizumab. [ Time Frame: From start of treatment to end of treatment, up to 36 months ]
  • Incidence of treatment-emergent adverse events as assessed by NCI CTCAE v.4.03, of CPI-006 as single agent and in combination with CPI-444 and with pembrolizumab. [ Time Frame: From start of treatment to end of treatment, up to 36 months ]
  • Identify the MDL(maximum dose level) of single agent CPI-006 [ Time Frame: From start of treatment to end of treatment, up to 36 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 16, 2020)
  • Area under the curve (AUC) of CPI-006 [ Time Frame: Day 1, 2, 8 , and 15 of Cycle 1 & 4 (each cycle is 21 days). ]
  • Maximum serum concentration (Cmax) of CPI-006 [ Time Frame: Day 1, 2, 8 , and 15 of Cycle 1 & 4 (each cycle is 21 days). ]
  • Objective response rate per RECIST v.1.1 criteria of CPI-006 as single agent and in combination with ciforadenant and with pembrolizumab. [ Time Frame: From start of treatment to end of treatment, up to 36 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2018)
  • Area under the curve (AUC) of CPI-006 [ Time Frame: Day 1, 2, 8 , and 15 of Cycle 1 & 4 (each cycle is 21 days). ]
  • Maximum serum concentration (Cmax) of CPI-006 [ Time Frame: Day 1, 2, 8 , and 15 of Cycle 1 & 4 (each cycle is 21 days). ]
  • Objective response rate per RECIST v.1.1 criteria of CPI-006 as single agent and in combination with CPI-444 and with pembrolizumab. [ Time Frame: From start of treatment to end of treatment, up to 36 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CPI-006 Alone and in Combination With Ciforadenant and With Pembrolizumab for Patients With Advanced Cancers
Official Title  ICMJE A PHASE 1/1b MULTICENTER STUDY TO EVALUATE THE HUMANIZED ANTI-CD73 ANTIBODY, CPI-006, AS A SINGLE AGENT OR IN COMBINATION WITH CIFORADENANT, WITH PEMBROLIZUMAB, AND WITH CIFORADENANT PLUS PEMBROLIZUMAB IN ADULT SUBJECTS WITH ADVANCED CANCERS
Brief Summary This is a Phase 1/1b open-label, dose escalation and dose expansion study of CPI-006, a humanized monoclonal antibody (mAb) targeting the CD73 cell-surface ectonucleotidase in adult subjects with select advanced cancers. CPI-006 will be evaluated as a single agent, in combination with ciforadenant (an oral adenosine 2A receptor antagonist), in combination with pembrolizumab (an anti-PD1 antibody), and in combination with ciforadenant and pembrolizumab.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Non-Small Cell Lung Cancer
  • Renal Cell Cancer
  • Colorectal Cancer
  • Triple Negative Breast Cancer
  • Cervical Cancer
  • Ovarian Cancer
  • Pancreatic Cancer
  • Endometrial Cancer
  • Sarcoma
  • Squamous Cell Carcinoma of the Head and Neck
  • Bladder Cancer
  • Metastatic Castration Resistant Prostate Cancer
  • Non-hodgkin Lymphoma
Intervention  ICMJE
  • Drug: CPI-006
    Subjects will receive escalating doses of CPI-006 administered intravenously once every 21 days until MTD is reached or until disease progression.
  • Drug: 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.
  • Drug: 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.
  • Drug: CPI-006
    Selected dose of CPI-006 administered intravenously once every 21 days until disease progression.
  • Drug: 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.
  • Drug: CPI-006 + pembrolizumab
    Selected dose of CPI-006 in combination with pembrolizumab administered intravenously once every 21 days until disease progression.
Study Arms  ICMJE
  • Experimental: Cohort 1a
    CPI-006
    Intervention: Drug: CPI-006
  • Experimental: Cohort1b
    CPI-006 + ciforadenant
    Intervention: Drug: CPI-006 + ciforadenant
  • Experimental: Cohort 1c
    CPI-006 + pembrolizumab
    Intervention: Drug: CPI-006 + pembrolizumab
  • Experimental: Cohort 2a
    CPI-006
    Intervention: Drug: CPI-006
  • Experimental: Cohort 2b
    CPI-006 + ciforadenant
    Intervention: Drug: CPI-006 + ciforadenant
  • Experimental: Cohort 2c
    CPI-006 + pembrolizumab
    Intervention: Drug: CPI-006 + pembrolizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 2, 2018)
378
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

  1. History of severe hypersensitivity reaction to monoclonal antibodies.
  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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Australia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03454451
Other Study ID Numbers  ICMJE CPI-006-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Corvus Pharmaceuticals, Inc.
Study Sponsor  ICMJE Corvus Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: S Mahabhashyam, MD Corvus Pharmaceuticals
PRS Account Corvus Pharmaceuticals, Inc.
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP