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

Completed · Phase 2 · Has a placebo group

Conditions studied: Carcinoma, Squamous Cell of Head and Neck

In brief

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.

Key facts

Study ID

NCT01836029

Run by

Celgene

People needed

195

Starts

2013-10-14

Expected to finish

2016-09-19

Last updated by the study team

2019-10-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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

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
• Other conditions or circumstances that could interfere with the study

Where it is running

• 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
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.