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Brief Title: Chemotherapy Plus Cetuximab in Combination With VTX-2337 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of Chemotherapy Plus Cetuximab in Combination With VTX 2337 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Study ID: NCT01836029
Brief Summary: The purpose of this study is to compare the progression-free survival of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) treated with VTX-2337 + cisplatin or carboplatin + 5-FU + cetuximab versus patients treated with cisplatin or carboplatin + 5-FU + cetuximab alone (standard-of-care; SOC). Safety and overall survival will also be evaluated.
Detailed Description: This is a randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of VTX 2337 in combination with cisplatin or carboplatin, 5-FU and cetuximab in prolonging the progression-free survival in subjects with recurrent or metastatic squamous cell carcinoma of the head and neck. OBJECTIVES: Primary Objective: To compare the efficacy of VTX 2337 plus SOC to SOC alone in prolonging the PFS of patients with recurrent or metastatic SCCHN using irRECIST evaluated by independent radiology review. Secondary Objectives: To compare the following between the two treatment groups: * Safety of VTX 2337 by adverse events, including clinically significant changes in physical examination, peripheral blood hematology, serum chemistry, urinalysis, and ECG. * Efficacy of VTX 2337 plus SOC in prolonging the OS of patients with recurrent or metastatic SCCHN. * Efficacy of VTX-2337 plus SOC on ORR, DOBR, DCR, and DDC by irRECIST and evaluation by independent radiology review. * Efficacy of VTX-2337 plus SOC on ORR, DOBR, DCR, and DDC by RECIST v1.1 and evaluation by independent radiology review. * Efficacy of VTX 2337 plus SOC to SOC alone in prolonging the PFS by RECIST v1.1 and evaluation by independent radiology review. * Efficacy of VTX 2337 plus SOC to SOC alone in prolonging the PFS by irRECIST and evaluation by investigators. Exploratory Objectives: * To compare genetic polymorphisms that may impact the response of patients to a TLR8 agonist or to cetuximab between the two treatment groups. * To compare immune biomarker response to VTX 2337 plus SOC as measured by a multiplexed panel of cytokines, chemokines, and inflammatory markers between the two treatment groups. * To compare the effect of immune cell subsets within the tumor on response to VTX-2337 and/or clinical outcome, as measured by immunohistochemistry in primary tumor tissue between the two treatment groups. * To assess the PK of VTX-2337. OUTLINE: Subjects will be screened for eligibility (within 14 days) and qualified subjects will be randomized 1:1 to 1 of 2 treatment groups: SOC + VTX 2337 or SOC + placebo. Tumor assessments will be by CT or MRI starting at Week 12 (± 3 days), then at Week 18 (± 3 days) and every 8 weeks (± 7 days) thereafter. Response will be evaluated by immune-related RECIST criteria (irRECIST) and confirmed by an independent radiologist. Upon independent confirmation of disease progression, active participation in the study is complete and subjects will undergo the End of Treatment evaluations. Subjects will be followed for survival until \~12 months after the last subject is randomized.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
Tower Hematology Oncology Medical Group, Beverly Hills, California, United States
California Cancer Associates for Research and Excellence (CCARE), Escondido, California, United States
University of California San Diego Moores Cancer Center, La Jolla, California, United States
University of California Norris Comprehensive Cancer Center, Los Angeles, California, United States
University of Colorado Cancer Center, Aurora, Colorado, United States
VA Eastern Colorado Healthcare System, Denver, Colorado, United States
Helen F. Graham Cancer Center, Newark, Delaware, United States
MD Anderson Cancer Center, Orlando, Florida, United States
Northeast Georgia Cancer Care, LLC, Athens, Georgia, United States
Winship Cancer Institute, Atlanta, Georgia, United States
Tripler Army Medical Center, Honolulu, Hawaii, United States
Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States
Carle Cancer Center, Urbana, Illinois, United States
University of Kansas Cancer Center, Westwood, Kansas, United States
Crescent City Research Consortium, LLC, Marrero, Louisiana, United States
Robert W. Veith, MD, LLC, Metairie, Louisiana, United States
Maine Center for Cancer Medicine, Scarborough, Maine, United States
The Sidney Kimmel Comprehensive Cancer Center at John Hopkins, Baltimore, Maryland, United States
Walter Reed National Military Medical Center, Bethesda, Maryland, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Henry Ford Health System, Detroit, Michigan, United States
Providence Cancer Institute, Southfield, Michigan, United States
Saint Louis Cancer Care, LLP, Bridgeton, Missouri, United States
Barnes Jewish Hospital, Saint Louis, Missouri, United States
Nevada Cancer Research Foundation, Las Vegas, Nevada, United States
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States
Oncology and Hematology Specialists, P.A., Denville, New Jersey, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Monter Cancer Center, Lake Success, New York, United States
The Bellevue Hospital, New York, New York, United States
Mount Sinai Medical Center, New York, New York, United States
Stony Brook University Medical Center, Stony Brook, New York, United States
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina, United States
University of Cincinnati, Cincinnati, Ohio, United States
University Hospitals of Cleveland, Cleveland, Ohio, United States
Cleveland Clinic, Cleveland, Ohio, United States
Saint Charles Medical Center, Bend, Oregon, United States
Providence Cancer Center, Portland, Oregon, United States
Saint Lukes Cancer Centre, Easton, Pennsylvania, United States
Pennsylvania State Hershey Cancer Institute, Hershey, Pennsylvania, United States
University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States
Hollings Cancer Center, Charleston, South Carolina, United States
The West Clinic, Memphis, Tennessee, United States
University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, United States
San Antonio Military Medical Center, Fort Sam Houston, Texas, United States
Virginia Cancer Specialists, PD, Fairfax, Virginia, United States
Medical Oncology Associates, PS, Spokane, Washington, United States
Madigan Army Medical Center, Tacoma, Washington, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Aurora Advanced Healthcare, Inc., Wauwatosa, Wisconsin, United States
Name: Ezra Cohen, MD
Affiliation: University of Chicago
Role: STUDY_CHAIR
Name: Robert Ferris, MD, PhD
Affiliation: University of Pittsburgh
Role: STUDY_CHAIR
Name: Amar Patel, MD
Affiliation: Celgene
Role: STUDY_DIRECTOR