Clinical trial NCT03454451: CPI-006 Alone and in Combination With Ciforadenant and With Pembrolizumab for Patients With Advanced Cancers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: 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
Keywords: NSCLC
RCC
TNBC
mCRPC
CRC
Lung Cancer
Kidney Cancer
Rectal Cancer
Breast Cancer
Sarcoma
Endometrial
Pancreatic
Ovarian
SCCHN
NHL
Lead sponsor: Corvus Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2018-03-06
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of dose-limiting toxicities (DLTs) of CPI-006 as a single agent and in combination with ciforadenant and with pembrolizumab.
timeFrame: From start of treatment to end of treatment, up to 36 months
measure: 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.
timeFrame: From start of treatment to end of treatment, up to 36 months
measure: Identify the MDL(maximum dose level) of single agent CPI-006
timeFrame: From start of treatment to end of treatment, up to 36 months
Secondary outcomes:
measure: Area under the curve (AUC) of CPI-006
timeFrame: Day 1, 2, 8 , and 15 of Cycle 1 & 4 (each cycle is 21 days).
measure: Maximum serum concentration (Cmax) of CPI-006
timeFrame: Day 1, 2, 8 , and 15 of Cycle 1 & 4 (each cycle is 21 days).
measure: Objective response rate per RECIST v.1.1 criteria of CPI-006 as single agent and in combination with ciforadenant and with pembrolizumab.
timeFrame: From start of treatment to end of treatment, up to 36 months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Oncology
state: Arizona
city: Duarte
country: United States
facility: City Of Hope
state: California
city: San Francisco
country: United States
facility: UC San Francisco
state: California
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
city: Baltimore
country: United States
facility: The John Hopkins University
state: Maryland
city: Boston
country: United States
facility: Dana Farber
state: Massachusetts
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Albany
country: United States
facility: NY Hematology
state: New York
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Huntsville
country: United States
facility: Carolina BioOncology Institute
state: North Carolina
city: Cincinnati
country: United States
facility: Oncology Hematology Care
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma - Stephenson Cancer Center
state: Oklahoma
city: Pittsburgh
country: United States
facility: UPMC Hillman
state: Pennsylvania
city: Greenville
country: United States
facility: Greenville
state: South Carolina
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Dallas
country: United States
facility: Mary Crowley Cancer Research
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer
state: Virginia
city: Milwaukee
country: United States
facility: Froedtert Hospital & Medical College of Wisconsin
state: Wisconsin
city: Camperdown
country: Australia
facility: Lifehouse
state: New South Wales
city: Darlinghurst
country: Australia
facility: St. Vincent's Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane
state: Queensland
city: Clayton
country: Australia
facility: Monash Hospital
state: Victoria
Study officials:
affiliation: Corvus Pharmaceuticals
name: S Mahabhashyam, MD
role: STUDY_CHAIR
References: