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7H-13-2-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

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. 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 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.

Phase

Phase 2 - takes the treatment one step further, assessing the activity of a particular therapy in a disease, often building upon leads from the Phase I trial. While patients are generally required to be previously untreated, participation in a Phase II trial doesn't usually preclude the patient from getting the standard treatment after they've received the investigational agent. At best they are allowed to get a new drug they wouldn't be able to get otherwise that may turn out to be better for their disease.

Inclusion and Exclusion 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 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

  • 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
  • Other conditions or circumstances that could interfere with the study

Sites

  • California

    • University of California Norris Comprehensive Cancer Center, Los Angeles, California, 90033
    • Tower Hematology Oncology Medical Group, Beverly Hills, California, 90211
    • California Cancer Associates for Research and Excellence (CCARE), Escondido, California, 92025
    • University of California San Diego Moores Cancer Center, La Jolla, California, 92093
  • Nevada

    • Nevada Cancer Research Foundation, Las Vegas, Nevada, 89106
  • Arizona

    • Mayo Clinic Arizona, Scottsdale, Arizona, 85259
  • Oregon

    • Saint Charles Medical Center, Bend, Oregon, 97701
    • Providence Cancer Center, Portland, Oregon, 97213
  • Colorado

    • VA Eastern Colorado Healthcare System, Denver, Colorado, 80220
    • University of Colorado Cancer Center, Aurora, Colorado, 80045
  • Washington

    • Madigan Army Medical Center, Tacoma, Washington, 98431
    • Medical Oncology Associates, PS, Spokane, Washington, 99208
  • Texas

    • San Antonio Military Medical Center, Fort Sam Houston, Texas, 78234
  • Kansas

    • University of Kansas Cancer Center, Westwood, Kansas, 66205
  • Arkansas

    • University of Arkansas for Medical Sciences, Little Rock, Arkansas, 72205
  • Missouri

    • Saint Louis Cancer Care, LLP, Bridgeton, Missouri, 63044
    • Barnes Jewish Hospital, St. Louis, Missouri, 63110
  • Tennessee

    • The West Clinic, Memphis, Tennessee, 38120
  • Louisiana

    • Crescent City Research Consortium, LLC, Marrero, Louisiana, 70072
  • Illinois

    • Carle Cancer Center, Urbana, Illinois, 61801
    • Northwestern University Feinberg School of Medicine, Chicago, Illinois, 60611
  • Wisconsin

    • Medical College of Wisconsin, Milwaukee, Wisconsin, 53226
    • Aurora Advanced Healthcare, Inc., Wauwatosa, Wisconsin, 53226
  • Georgia

    • Winship Cancer Institute, Atlanta, Georgia, 30322
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