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Carcinoma, Squamous Cell of Head and NeckPhase 2NCT01836029

Chemotherapy Plus Cetuximab in Combination With VTX-2337 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

A Phase 2 study testing VTX-2337, Carboplatin and Cisplatin in people with Carcinoma, Squamous Cell of Head and Neck, run by Celgene at 53 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
VTX-2337, Carboplatin and Cisplatin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
195 participants
Where
53 sitesUnited States
Study dates
14 Oct 2013to 19 Sep 2016
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • 18 years of age or older
  • ECOG performance status of 0 or 1
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

53 sites in 1 country.

53 sites in 1 country

United States53 sites

  • Northeast Georgia Cancer Care, LLC

    Athens, Georgia, 30607

  • Winship Cancer Institute

    Atlanta, Georgia, 30322

  • University of Colorado Cancer Center

    Aurora, Colorado, 80045

  • The Sidney Kimmel Comprehensive Cancer Center at John Hopkins

    Baltimore, Maryland, 21231

  • Saint Charles Medical Center

    Bend, Oregon, 97701

  • Walter Reed National Military Medical Center

    Bethesda, Maryland, 20889

  • Tower Hematology Oncology Medical Group

    Beverly Hills, California, 90211

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Saint Louis Cancer Care, LLP

    Bridgeton, Missouri, 63044

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Hollings Cancer Center

    Charleston, South Carolina, 29425

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, 60611

  • University of Cincinnati

    Cincinnati, Ohio, 45267-0502

  • University Hospitals of Cleveland

    Cleveland, Ohio, 44106

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas, 75390-8852

  • VA Eastern Colorado Healthcare System

    Denver, Colorado, 80220

  • Oncology and Hematology Specialists, P.A.

    Denville, New Jersey, 07834

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Saint Lukes Cancer Centre

    Easton, Pennsylvania, 18045

  • California Cancer Associates for Research and Excellence (CCARE)

    Escondido, California, 92025

  • Virginia Cancer Specialists, PD

    Fairfax, Virginia, 22031

  • San Antonio Military Medical Center

    Fort Sam Houston, Texas, 78234

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Pennsylvania State Hershey Cancer Institute

    Hershey, Pennsylvania, 17033

  • Tripler Army Medical Center

    Honolulu, Hawaii, 96859

  • University of California San Diego Moores Cancer Center

    La Jolla, California, 92093

  • Monter Cancer Center

    Lake Success, New York, 11042

  • Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • University of California Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Crescent City Research Consortium, LLC

    Marrero, Louisiana, 70072

  • The West Clinic

    Memphis, Tennessee, 38120

  • Robert W. Veith, MD, LLC

    Metairie, Louisiana, 70006-2936

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • The Bellevue Hospital

    New York, New York, 10016

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Helen F. Graham Cancer Center

    Newark, Delaware, 19713

  • MD Anderson Cancer Center

    Orlando, Florida, 32806

  • University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15232

  • Providence Cancer Center

    Portland, Oregon, 97213

  • Maine Center for Cancer Medicine

    Scarborough, Maine, 04074

  • Providence Cancer Institute

    Southfield, Michigan, 48075

  • Medical Oncology Associates, PS

    Spokane, Washington, 99208

  • Barnes Jewish Hospital

    St Louis, Missouri, 63110

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • Madigan Army Medical Center

    Tacoma, Washington, 98431

  • Carle Cancer Center

    Urbana, Illinois, 61801

  • Aurora Advanced Healthcare, Inc.

    Wauwatosa, Wisconsin, 53226

  • University of Kansas Cancer Center

    Westwood, Kansas, 66205

  • Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
VTX-2337, Carboplatin, Cisplatin, 5-fluorouracil, Placebo
Keywords
SCCHN, HNSCC
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01836029
Study groupRoleWhat they receive
chemotherapy and cetuximab plus VTX-2337ExperimentalVTX-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.
Receives: Drug: VTX-2337; Drug: Carboplatin; Drug: Cisplatin; Drug: 5-fluorouracil
chemotherapy and cetuximab plus placeboActive 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.
Receives: Drug: Carboplatin; Drug: Cisplatin; Drug: 5-fluorouracil; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: PFS is the time from randomization until disease progression or death, whichever comes first.

Secondary outcomes (3)

  1. Comparison of Adverse Events (AEs) Between the Two Treatment Groups.

    The frequency and severity of adverse events, including any clinically significant changes in physical exam, laboratory values, or other clinical assessment.

    Measured: 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.

  2. Comparison of Overall Survival (OS) Between the 2 Treatment Groups.

    Estimated using Kaplan-Meier product limit estimates, 1-sided stratified log-rank test, and Cox proportional hazard model; all with 90% 1-sided confidence intervals.

    Measured: OS is the time from randomization until death due to any cause or the date last confirmed to be alive.

  3. Comparison of the Objective Response Rate Between the Two Treatment Groups p

    Objective response rate is defined as the percentage of subjects who achieve best overall response of irCR or irPR pr irRECIST and evaluated by independent radiology..

    Measured: From the time of randomization until the best response on treatment is documented.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2013 (estimated)
  2. Study start14 Oct 2013
  3. Primary completion13 Apr 2016
  4. Study completion19 Sep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
195 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01836029
Sponsor's protocol ID
VRXP-A202
Status last verified
Oct 2019
First submitted
12 Apr 2013
Last updated
29 Oct 2019
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 29931076

  • 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.

    PubMed 27810904

  • 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.

    PubMed 24807889

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VTX-2337, Carboplatin and Cisplatin in people with Carcinoma, Squamous Cell of Head and Neck, run by Celgene at 53 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of Progression Free Survival (PFS) Between Treatment Groups Using irRECIST and Evaluated by Independent Radiology. (time frame: PFS is the time from randomization until disease progression or death, whichever comes first.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01836029, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2019.

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