Spots Global Cancer Trial Database for Cisplatin + Radiotherapy vs Durvalumab + Radiotherapy Followed by Durvalumab vs Durvalumab + Radiotherapy Followed by Tremelimumab + Durvalumab in Intermediate-Risk HPV-Positive Oropharyngeal SCC
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Trial Identification
Brief Title: Cisplatin + Radiotherapy vs Durvalumab + Radiotherapy Followed by Durvalumab vs Durvalumab + Radiotherapy Followed by Tremelimumab + Durvalumab in Intermediate-Risk HPV-Positive Oropharyngeal SCC
Official Title: Randomized Phase II Study of Cisplatin Plus Radiotherapy Versus Durvalumab Plus Radiotherapy Followed by Adjuvant Durvalumab Versus Durvalumab Plus Radiotherapy Followed by Adjuvant Tremelimumab and Durvalumab in Intermediate Risk HPV-Positive Locoregionally Advanced Oropharyngeal Squamous Cell Cancer (LA-OSCC)
Study ID: NCT03410615
Conditions
Study Description
Brief Summary: Sometimes, cancer patients receive an initial treatment, followed by additional treatment to lower the chance of cancer coming back. The standard or usual treatment for this type of disease is initially having radiation therapy at the same time as chemotherapy (with a drug called cisplatin), with no additional therapy afterwards
Detailed Description: This study is looking at whether a type of drug called durvalumab can be used with radiation during the initial treatment, (instead of cisplatin) and also afterwards as additional therapy. Durvalumab is an immunotherapy drug . It has been tested in many different types of cancers. Durvalumab works by allowing the immune system to detect the cancer and reactivate the immune response. This may help to slow down the growth of cancer or may cause cancer cells to die. Durvalumab has been shown to shrink tumours in animals. It has been studied in more than 5000 people, approved for use in other cancers and seems promising. This clinical trial will also test another type of immunotherapy drug called tremelimumab, which would also be given as additional treatment. Tremelimumab works in a different way to durvalumab to enhance the immune system reaction against cancer cells and may improve the effect of durvalumab. Tremelimumab may also help slow the growth of the cancer cells or may cause cancer cells to die. It has been shown to shrink tumours in animals. Tremelimumab has been studied in over 1200 people, approved for use in other cancers and seems promising. As of February 2019, tremelimumab will no longer be tested with new participants joining the study.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Cliniques Universitaires Saint-Luc, Brussels, , Belgium
University Hospital of Antwerp, Edegem, , Belgium
University Hospital of Gent, Gent, , Belgium
University Hospital Leuven, Leuven, , Belgium
Clinique St. Elizabeth, Namur, , Belgium
AZ Sint Augustinus, Wilrijk, , Belgium
Cross Cancer Institute, Edmonton, Alberta, Canada
CancerCare Manitoba, Winnipeg, Manitoba, Canada
QEII Health Sciences Centre, Halifax, Nova Scotia, Canada
Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario, Canada
Kingston Health Sciences Centre, Kingston, Ontario, Canada
London Regional Cancer Program, London, Ontario, Canada
Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
Health Sciences North, Sudbury, Ontario, Canada
University Health Network, Toronto, Ontario, Canada
The Jewish General Hospital, Montreal, Quebec, Canada
The Research Institute of the McGill University, Montreal, Quebec, Canada
CIUSSS de l'Estrie - Centre hospitalier, Sherbrooke, Quebec, Canada
Allan Blair Cancer Centre, Regina, Saskatchewan, Canada
Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, , Italy
Complejo Hospitalario de Navarra, Pamplona, Navarra, Spain
University Hospital Vall dHebron, Barcelona, , Spain
Hospital Duran i Reynals, Barcelona, , Spain
University Hospital Ramon y Cajal, Madrid, , Spain
University Clinical Hospital of Valencia, Valencia, , Spain
Contact Details
Name: Anna Spreafico
Affiliation: UNH/Princess Margaret Cancer Centre, Toronto ON Canada
Role: STUDY_CHAIR
Name: Khalil Sultanem
Affiliation: The Jewish General Hospital, Montreal QC, Canada
Role: STUDY_CHAIR
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