Phase 2
Completed N=195
Chemotherapy Plus Cetuximab in Combination With VTX-2337 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Source: ClinicalTrials.gov NCT01836029 ↗Enrolled (actual)
195
Serious AEs
39.4%
Results posted
Oct 2019
Primary outcomePrimary: Comparison of Progression Free Survival (PFS) Between Treatment Groups Using irRECIST and Evaluated by Independent Radiology. — 185; 181 days — p=0.266
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 (standard-of-care; SOC). Safety and overall survival will also be evaluated.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of Progression Free Survival (PFS) Between Treatment Groups Using irRECIST and Evaluated by Independent Radiology. |
185; 181 | 0.266 |
| SECONDARY Comparison of Adverse Events (AEs) Between the Two Treatment Groups. |
100; 100; 84.3; 83.7; 39.3; 39.5 | — |
| SECONDARY Comparison of Overall Survival (OS) Between the 2 Treatment Groups. |
412; 343 | 0.399 |
| SECONDARY Comparison of the Objective Response Rate Between the Two Treatment Groups p |
38.0; 33.7 | 0.536 |
Eligibility Criteria
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 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 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 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
Data sourced from ClinicalTrials.gov (NCT01836029). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.