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

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

INTRODUCTION

  • Org Study ID: CPI-006-001
  • Secondary ID: N/A
  • NTC ID: NCT03454451
  • Sponsor: Corvus Pharmaceuticals, Inc.

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.

  • Overall Status
    Recruiting
  • Start Date
    April 25, 2018
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Incidence of dose-limiting toxicities (DLTs) of CPI-006 as a single agent and in combination with ciforadenant and with pembrolizumab.

Primary Outcome 1 - Timeframe: From start of treatment to end of treatment, up to 36 months

Primary Outcome 2 - 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.

Primary Outcome 2 - Timeframe: From start of treatment to end of treatment, up to 36 months

Primary Outcome 3 - Measure: Identify the MDL(maximum dose level) of single agent CPI-006

Primary Outcome 3 - Timeframe: From start of treatment to end of treatment, up to 36 months

CONDITION

  • 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

ELIGIBILITY

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

- 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.

- At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST 1.1).

- 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.

- Willingness to provide tumor biopsies.
Exclusion Criteria
History of severe hypersensitivity reaction to monoclonal antibodies.

- 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.

- History of (non-infectious) pneumonitis that required steroids or subject has current pneumonitis.

- The use of any investigational medication or device in the 30 days prior to screening and throughout the study is prohibited.

- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: S Mahabhashyam, MD

Role: Study Chair

Affiliation: Corvus Pharmaceuticals

Overall Contact

Name: S Mahabhashyam, MD

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact
Facility: Arizona Oncology Associates, PC - HOPE
Tucson, Arizona 85711
United States
Status: Recruiting Contact: Contact
C Clark
650-900-4520
cpi006-communications@corvuspharma.com
Facility: City Of Hope
Duarte, California 91010
United States
Status: Recruiting Contact: Principal Investigator
Sudhir Manda
650-900-4520
cpi006-communications@corvuspharma.com
Facility: UCSF Medical Center
San Francisco, California 94143
United States
Status: Recruiting Contact: Contact
C Clark
650-900-4520
cpi006-communications@corvuspharma.com
Facility: Yale School of Medicine
New Haven, Connecticut 06519
United States
Status: Recruiting Contact: Principal Investigator
Sumanta Pal, MD
203-785-3482
ycci@yale.edu
Facility: University of Miami
Miami, Florida 33136
United States
Status: Recruiting Contact: Contact
C Clark
305-243-0865
txl351@med.miami.edu
Facility: Northwestern University
Chicago, Illinois 60611
United States
Status: Recruiting Contact: Principal Investigator
Lawrence Fong
650-900-4520
cpi006-communications@corvuspharma.com
Facility: The University of Chicago
Chicago, Illinois 60637
United States
Status: Recruiting Contact: Contact
Site Coordinator
650-900-4520
cpi006-communications@corvuspharma.com
Facility: The John Hopkins University
Baltimore, Maryland 21224
United States
Status: Recruiting Contact: Principal Investigator
Patricia LoRusso, MD
650-900-4520
cpi006-communications@corvuspharma.com
Facility: Dana Farber Cancer Institute
Boston, Massachusetts 02215
United States
Status: Recruiting Contact: Contact
Study Coordinator
650-900-4520
cpi006-communications@corvuspharma.com
Facility: Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada 89169
United States
Status: Recruiting Contact: Principal Investigator
Jaime Merchan, MD
650-900-4520
cpi006-communications@corvuspharma.com
Facility: New York Oncology Hematology, P.C.
Albany, New York 12206
United States
Status: Recruiting Contact: Contact
C Clark
650-900-4520
cpi006-communications@corvuspharma.com
Facility: Roswell Park Cancer Institute
Buffalo, New York 14263
United States
Status: Recruiting Contact: Principal Investigator
Jeffrey Sosman
650-900-4520
cpi006-communications@corvuspharma.com
Facility: Icahn School of Medicine at Mount Sinai
New York, New York 10029
United States
Status: Recruiting Contact: Contact
C Clark
212-824-7309
ccto@mssm.edu
Facility: Carolina BioOncology Institute
Huntsville, North Carolina 28078
United States
Status: Recruiting Contact: Principal Investigator
Walter Stadler, MD
704-947-6599
info@carolinabiooncology.org
Facility: Oncology Hematology Care, Inc.
Cincinnati, Ohio 45242
United States
Status: Recruiting Contact: Contact
C Clark
650-900-4520
cpi006-communications@corvuspharma.com
Facility: University of Oklahoma - Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
United States
Status: Recruiting Contact: Principal Investigator
Kristen Marrone
405-271-1112
SCC-Clinical-Trials-Office@ouhsc.edu
Facility: UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
United States
Status: Recruiting Contact: Contact
C Clark
650-900-4520
cpi006-communications@corvuspharma.com
Facility: Prisma Health Cancer Inst - Faris
Greenville, South Carolina 29605
United States
Status: Recruiting Contact: Principal Investigator
Toni Choueiri, MD
650-900-4520
cpi006-communications@corvuspharma.com
Facility: Sarah Cannon Research Institute
Nashville, Tennessee 37203
United States
Status: Recruiting Contact: Contact
C Clark
615-329-7274
asksarah@sarahcannon.com
Facility: Virginia Cancer Specialists, PC
Fairfax, Virginia 22031
United States
Status: Recruiting Contact: Contact
C Clark
650-900-4520
cpi006-communications@corvuspharma.com
Facility: Chris O'Brien Lifehouse
Camperdown, New South Wales 2050
Australia
Status: Recruiting Contact: Contact
C Clark
650-900-4520
cpi006-communications@corvuspharma.com
Facility: St. Vincent's Hospital
Darlinghurst, New South Wales 2010
Australia
Status: Recruiting Contact: Principal Investigator
Igor Puzanov
650-900-4520
cpi006-communications@corvuspharma.com
Facility: Westmead Hospital
Westmead, New South Wales 3168
Australia
Status: Recruiting Contact: Contact
Site Coordinator
650-900-4520
cpi006-communications@corvuspharma.com
Facility: Royal Brisbane and Women's Hospital
Herston, Queensland 4029
Australia
Status: Recruiting Contact: Principal Investigator
Thomas Marron, MD

Facility: Monash Health
Clayton, Victoria 3168
Australia
Status: Recruiting Contact: Contact
Study Coordinator