Spots Global Cancer Trial Database for EMD 1201081 in Combination With Cetuximab in Second-Line Cetuximab-Naïve Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
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Trial Identification
Brief Title: EMD 1201081 in Combination With Cetuximab in Second-Line Cetuximab-Naïve Subjects With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
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)
Study ID: NCT01040832
Study Description
Brief Summary: 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Colorado Cancer Center, Aurora, Colorado, United States
University of Kentucky, Markey Cancer Center, Lexington, Kentucky, United States
MGH Massachusetts General Hospital, Boston, Massachusetts, United States
Montefiore Medical Center Oncology, Bronx, New York, United States
Research Site, Brussels, , Belgium
UZ Gent, Gent, , Belgium
Research Site, Wilrijk, , Belgium
Cliniques Universitaires Mont-Godinne, Yvoir, , Belgium
Research Site, Brno, , Czech Republic
Research Site, Kladno, , Czech Republic
Research Site, Pardubice, , Czech Republic
Ustav radiacni onkologie Fakultni nemacnice Na Bulovce, Praha, , Czech Republic
Research Site, Montpellier, , France
Research Site, Villejuif, , France
Research Site, Győr, , Hungary
Research Site, Kecskemét, , Hungary
Research Site, Miskolc, , Hungary
Research Site, Nyiregyahaza, , Hungary
Szegedi Tudomayegyetem Altalanos Orvostudomanyi Kar Onkoterapias Klinika, Szeged, , Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet, Szolnok, , Hungary
Zala Megyei Kohaz Kulsokorhaz Onkologia Osztaly, Zalaegerszeg, , Hungary
SPZOZ Centrum Onkologi Liemi Lubelskiej, II Odzial Radioterapiii z pododdzialem Chemioterpii, Lublin, , Poland
Zaklad Opleki Zdrowotnej MSWIA z Warminsko-Mazurskim Centrum Onkologil, Oddziat Chemioterapli, Olsztyn, , Poland
Centrum Onkologi - Instytut im. Marii Sklodowskiej-Curie, Klinika Nowotworow Glowy i Szyi (NCI), Warszawa, , Poland
Onkologicky ustav Sv. Alzbety, Bratislava, , Slovakia
Nemocnice s poliklinikou Zilina, Zilina, , Slovakia
Velindre Cancer Centre, Cardiff, , United Kingdom
Research Site, Conventry, , United Kingdom
MHCW, Coventry, , United Kingdom
St. James' University Hospital, Leeds, , United Kingdom
Research Site, London, , United Kingdom
The Christie NHS FT, Manchester, , United Kingdom
Research Site, Newcastle upon Tyne, , United Kingdom
Weston Park Hospital, Sheffield, , United Kingdom
Southampton University Hospitals NHS Trust, Southampton, , United Kingdom
Contact Details
Name: Philip Breitfeld, MD
Affiliation: EMD Serono, Inc., Rockland MA, a subsidiary of Merck KGaA, Darmstadt, Germany
Role: STUDY_DIRECTOR
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