Squamous Cell Carcinoma of the Head and Neck Cancer Clinical Trial
Official title:
A Phase II, Open-label, 1:1 Randomized, Controlled Trial Exploring the Efficacy of EMD 1201081 in Combination With Cetuximab in Second-Line Cetuximab-Naïve Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (R/M SCCHN)
The purpose of this study is to determine if EMD 1201081 in combination with cetuximab is
more efficient than cetuximab alone to control the cancer.
EMD 1201081 is an immune modulatory oligonucleotide (IMO) containing phosphorothioate
oligodeoxynucleotide and acts as an agonist of Toll-like receptor 9 (TLR9).
EMD 1201081 has been studied in six clinical trials in over 170 subjects either as a
monotherapy or in combination with chemotherapeutic agents or targeted therapies. Two
studies have been conducted in healthy volunteers. In the other five studies, subjects with
advanced solid tumors, renal cell carcinoma, non-small cell lung cancer and colorectal
cancer have been treated with EMD 1201081. Two studies are still ongoing. Future clinical
development of EMD 1201081 will focus on colorectal cancer (CRC) and squamous cell cancer of
the head and neck (SCCHN).
In this Phase 2 study, subjects with recurrent or metastatic squamous cell cancer of the
head and neck (R/M SCCHN), will be treated with cetuximab plus EMD 1201081 or cetuximab
alone. The study will be conducted as a multicenter study in several European Union (EU)
member states and the Unites States.
EMD 1201081 in combination with cetuximab will be evaluated for antitumor activity in
subjects by examining its effects on accepted clinical endpoints. Progression-free survival
(PFS) will be evaluated in subjects treated with EMD 1201081 plus cetuximab compared to
cetuximab alone in cetuximab-naïve subjects with R/M SCCHN who have progressed on a
cytotoxic therapy.
Cetuximab, approved in colorectal cancer and SCCHN in combination with platinum-based
chemotherapy and SCCHN in combination with radiotherapy in the EU, will be provided as
investigational medicinal product (IMP) in this study. Commercially available Cetuximab will
be provided in the United States.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02057107 -
SBRT With Cetuximab +/- Docetaxel Followed by Adjuvant Cetuximab +/- Docetaxel in Recurrent, Previously-Irradiated SCCHN
|
Phase 2 |