Chemotherapy Plus Cetuximab in Combination With VTX-2337 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
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
1 other identifier
interventional
195
1 country
53
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2013
Typical duration for phase_2
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2013
CompletedFirst Posted
Study publicly available on registry
April 19, 2013
CompletedStudy Start
First participant enrolled
October 14, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 13, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 19, 2016
CompletedResults Posted
Study results publicly available
October 29, 2019
CompletedOctober 29, 2019
October 1, 2019
2.5 years
April 12, 2013
August 14, 2019
October 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison of Progression Free Survival (PFS) Between Treatment Groups Using irRECIST and Evaluated by Independent Radiology.
PFS was based on central assessment by a blinded independent radiologist per immune related response evaluation criteria for solid tumors (irRECIST) and was summarized and displayed by treatment arm using Kaplan-Meier methods. Treatments were compared using a stratified log-rank test controlling for randomization stratification factors. The hazard ratio between the 2 treatment arms, as well as the associated one-sided 90% CI and p-value, were presented using a Cox proportional hazards regression model.
PFS is the time from randomization until disease progression or death, whichever comes first.
Secondary Outcomes (3)
Comparison of Adverse Events (AEs) Between the Two Treatment Groups.
AEs were collected from the first dose of study drug given on Cycle 1 Day 1 until 7 days after the dose of study drug or End of Treatment visit, whichever occurred first. Overall mean duration of exposure was 25.3 weeks.
Comparison of Overall Survival (OS) Between the 2 Treatment Groups.
OS is the time from randomization until death due to any cause or the date last confirmed to be alive.
Comparison of the Objective Response Rate Between the Two Treatment Groups p
From the time of randomization until the best response on treatment is documented.
Study Arms (2)
chemotherapy and cetuximab plus VTX-2337
EXPERIMENTALVTX-2337 (3.0 mg/m2) will be administered on Day 8 and Day 15 of a 21-day cycle for 6 cycles, followed by dosing on Days 8 and 22 of 28-day cycles until disease progression. Cisplatin (100 mg/m2) OR carboplatin (AUC 5 mg/mL/min) will be administered on Day 1 of a 21-day cycle for a maximum of 6 cycles. 5-FU (1000 mg/m2) will be administered on Days 1-4 of a 21-day cycle for a maximum of 6 cycles. Cetuximab (initial dose: 400 mg/m2; remaining doses: 250 mg/m2) will be administered weekly until disease progression.
chemotherapy and cetuximab plus placebo
ACTIVE COMPARATORPlacebo (3.0 mg/m2) will be administered on Day 8 and Day 15 of a 21-day cycle for 6 cycles, followed by dosing on Days 8 and 22 of 28-day cycles until disease progression. Cisplatin (100 mg/m2) OR carboplatin (AUC 5 mg/mL/min) will be administered on Day 1 of a 21-day cycle for a maximum of 6 cycles. 5-FU (1000 mg/m2) will be administered on Days 1-4 of a 21-day cycle for a maximum of 6 cycles. Cetuximab (initial dose: 400 mg/m2; remaining doses: 250 mg/m2) will be administered weekly until disease progression.
Interventions
Eligibility Criteria
You may qualify if:
- Ability and willingness to provide written informed consent
- Histologically or cytologically confirmed squamous cell carcinoma of the head and neck
- Locoregionally recurrent or metastatic disease that has not previously been treated with systemic therapy of recurrent or metastatic disease
- At least one measurable lesion on screening CT or MRI
- years of age or older
- ECOG performance status of 0 or 1
- Acceptable bone marrow, renal, and hepatic function based upon screening lab tests
- Willingness to use medically acceptable contraception
- For females with reproductive potential: a negative serum pregnancy test
You may not qualify if:
- Disease which is amenable to curative local therapy
- Nasopharyngeal, salivary gland, lip or sinonasal carcinoma
- Surgery or irradiation ≤ 4 weeks prior to randomization
- Prior systemic anti-cancer therapy, unless administered for localized SCCHN and completed at least 6 months prior to disease recurrence
- Treatment with an investigational agent ≤ 30 days prior to randomization
- Treatment with corticosteroids within 2 weeks
- A requirement for chronic systemic immunosuppressive therapy for any reason
- Prior serious infusion reaction to cetuximab
- Treatment with an immunotherapy within 30 days
- Known brain metastases, unless stable for at least 28 days
- Active autoimmune disease currently requiring therapy
- Known infection with HIV
- Significant cardiac disease within 6 months
- Pregnant or breast-feeding females
- History of another primary malignancy, with the exception of (i) curatively resected non-melanoma skin cancer, (ii) curatively treated in situ cervical cancer, or (iii) other malignancy curatively treated with no evidence of disease and no anticancer therapy administered for 3 years prior to randomization, with the exception of adjuvant hormonal therapy for breast cancer
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
Study Sites (53)
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Tower Hematology Oncology Medical Group
Beverly Hills, California, 90211, United States
California Cancer Associates for Research and Excellence (CCARE)
Escondido, California, 92025, United States
University of California San Diego Moores Cancer Center
La Jolla, California, 92093, United States
University of California Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
University of Colorado Cancer Center
Aurora, Colorado, 80045, United States
VA Eastern Colorado Healthcare System
Denver, Colorado, 80220, United States
Helen F. Graham Cancer Center
Newark, Delaware, 19713, United States
MD Anderson Cancer Center
Orlando, Florida, 32806, United States
Northeast Georgia Cancer Care, LLC
Athens, Georgia, 30607, United States
Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Tripler Army Medical Center
Honolulu, Hawaii, 96859, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
University of Kansas Cancer Center
Westwood, Kansas, 66205, United States
Crescent City Research Consortium, LLC
Marrero, Louisiana, 70072, United States
Robert W. Veith, MD, LLC
Metairie, Louisiana, 70006-2936, United States
Maine Center for Cancer Medicine
Scarborough, Maine, 04074, United States
The Sidney Kimmel Comprehensive Cancer Center at John Hopkins
Baltimore, Maryland, 21231, United States
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Providence Cancer Institute
Southfield, Michigan, 48075, United States
Saint Louis Cancer Care, LLP
Bridgeton, Missouri, 63044, United States
Barnes Jewish Hospital
St Louis, Missouri, 63110, United States
Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Oncology and Hematology Specialists, P.A.
Denville, New Jersey, 07834, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Monter Cancer Center
Lake Success, New York, 11042, United States
The Bellevue Hospital
New York, New York, 10016, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27103, United States
University of Cincinnati
Cincinnati, Ohio, 45267-0502, United States
University Hospitals of Cleveland
Cleveland, Ohio, 44106, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Saint Charles Medical Center
Bend, Oregon, 97701, United States
Providence Cancer Center
Portland, Oregon, 97213, United States
Saint Lukes Cancer Centre
Easton, Pennsylvania, 18045, United States
Pennsylvania State Hershey Cancer Institute
Hershey, Pennsylvania, 17033, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15232, United States
Hollings Cancer Center
Charleston, South Carolina, 29425, United States
The West Clinic
Memphis, Tennessee, 38120, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75390-8852, United States
San Antonio Military Medical Center
Fort Sam Houston, Texas, 78234, United States
Virginia Cancer Specialists, PD
Fairfax, Virginia, 22031, United States
Medical Oncology Associates, PS
Spokane, Washington, 99208, United States
Madigan Army Medical Center
Tacoma, Washington, 98431, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Aurora Advanced Healthcare, Inc.
Wauwatosa, Wisconsin, 53226, United States
Related Publications (3)
Ferris RL, Saba NF, Gitlitz BJ, Haddad R, Sukari A, Neupane P, Morris JC, Misiukiewicz K, Bauman JE, Fenton M, Jimeno A, Adkins DR, Schneider CJ, Sacco AG, Shirai K, Bowles DW, Gibson M, Nwizu T, Gottardo R, Manjarrez KL, Dietsch GN, Bryan JK, Hershberg RM, Cohen EEW. Effect of Adding Motolimod to Standard Combination Chemotherapy and Cetuximab Treatment of Patients With Squamous Cell Carcinoma of the Head and Neck: The Active8 Randomized Clinical Trial. JAMA Oncol. 2018 Nov 1;4(11):1583-1588. doi: 10.1001/jamaoncol.2018.1888.
PMID: 29931076DERIVEDChow LQM, Morishima C, Eaton KD, Baik CS, Goulart BH, Anderson LN, Manjarrez KL, Dietsch GN, Bryan JK, Hershberg RM, Disis ML, Martins RG. Phase Ib Trial of the Toll-like Receptor 8 Agonist, Motolimod (VTX-2337), Combined with Cetuximab in Patients with Recurrent or Metastatic SCCHN. Clin Cancer Res. 2017 May 15;23(10):2442-2450. doi: 10.1158/1078-0432.CCR-16-1934. Epub 2016 Nov 3.
PMID: 27810904DERIVEDNorthfelt DW, Ramanathan RK, Cohen PA, Von Hoff DD, Weiss GJ, Dietsch GN, Manjarrez KL, Randall TD, Hershberg RM. A phase I dose-finding study of the novel Toll-like receptor 8 agonist VTX-2337 in adult subjects with advanced solid tumors or lymphoma. Clin Cancer Res. 2014 Jul 15;20(14):3683-91. doi: 10.1158/1078-0432.CCR-14-0392. Epub 2014 May 7.
PMID: 24807889DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kristi Manjarrez
- Organization
- VentiRx
Study Officials
- STUDY CHAIR
Ezra Cohen, MD
University of Chicago
- STUDY CHAIR
Robert Ferris, MD, PhD
University of Pittsburgh
- STUDY DIRECTOR
Amar Patel, MD
Celgene
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2013
First Posted
April 19, 2013
Study Start
October 14, 2013
Primary Completion
April 13, 2016
Study Completion
September 19, 2016
Last Updated
October 29, 2019
Results First Posted
October 29, 2019
Record last verified: 2019-10