Status:
COMPLETED
Chemotherapy Plus Cetuximab in Combination With VTX-2337 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Lead Sponsor:
Celgene
Conditions:
Carcinoma, Squamous Cell of Head and Neck
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
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 prolong...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 14 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 19 2016
Estimated Enrollment :
195 Patients enrolled
Trial Details
Trial ID
NCT01836029
Start Date
October 14 2013
End Date
September 19 2016
Last Update
October 29 2019
Active Locations (53)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
2
Tower Hematology Oncology Medical Group
Beverly Hills, California, United States, 90211
3
California Cancer Associates for Research and Excellence (CCARE)
Escondido, California, United States, 92025
4
University of California San Diego Moores Cancer Center
La Jolla, California, United States, 92093