Chemotherapy Plus Cetuximab in Combination With VTX-2337 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
NCT ID: NCT01836029
Last Updated: 2019-10-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
195 participants
INTERVENTIONAL
2013-10-14
2016-09-19
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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chemotherapy and cetuximab plus VTX-2337
VTX-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.
VTX-2337
TLR8 Agonist
Carboplatin
Cisplatin
5-fluorouracil
chemotherapy and cetuximab plus placebo
Placebo (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.
Carboplatin
Cisplatin
5-fluorouracil
Placebo
Interventions
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VTX-2337
TLR8 Agonist
Carboplatin
Cisplatin
5-fluorouracil
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 18 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
Exclusion Criteria
* 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
* Other conditions or circumstances that could interfere with the study
18 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Ezra Cohen, MD
Role: STUDY_CHAIR
University of Chicago
Robert Ferris, MD, PhD
Role: STUDY_CHAIR
University of Pittsburgh
Amar Patel, MD
Role: STUDY_DIRECTOR
Celgene
Locations
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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
St 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
Countries
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References
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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.
Chow 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.
Northfelt 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.
Other Identifiers
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VRXP-A202
Identifier Type: -
Identifier Source: org_study_id
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