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Spots Global Cancer Trial Database for Chemotherapy Plus Cetuximab in Combination With VTX-2337 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

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Trial Identification

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

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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