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
18 Years
N/A
Both
Carcinoma, Squamous Cell of Head and Neck
Trial Information
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
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.
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.
Exploratory Objectives:
To compare the following between the two treatment groups:
- Genetic polymorphisms that may impact the response of patients to a TLR8 agonist or to
cetuximab.
- Immune biomarker response to VTX 2337 plus SOC as measured by a multiplexed panel of
cytokines, chemokines, and inflammatory markers.
- 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.
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.
Inclusion Criteria:
- 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
- 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:
- 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 locally advanced disease
and completed ≥ 6 months prior to randomization
- 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
- Other conditions or circumstances that could interfere with the study
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
To compare the efficacy of VTX-2337 plus SOC to SOC alone in prolonging the PFS of patients with recurrent or metastatic SCCHN.
Outcome Time Frame:
approximately 9 months after the last patient is randomized
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
VRXP-A202
NCT ID:
NCT01836029
Start Date:
July 2013
Completion Date:
December 2015
Related Keywords:
- Carcinoma, Squamous Cell of Head and Neck
- SCCHN
- HNSCC
- Carcinoma
- Carcinoma, Squamous Cell
- Head and Neck Neoplasms
Name | Location |
|---|---|
| University of Chicago | Chicago, Illinois 60637 |
