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Brief Title: Durvalumab and Tremelimumab and Best Supportive Care vs Best Supportive Care in Patients With Advanced Colorectal Cancer
Official Title: A Phase II Randomized Study of Durvalumab and Tremelimumab and Best Supportive Care vs Best Supportive Care Alone in Patients With Advanced Colorectal Adenocarcinoma Refractory to Standard Therapies
Study ID: NCT02870920
Brief Summary: The standard or usual treatment for this disease is treatment with drugs and other treatments that may help to make a patient better or may improve their quality of life. This treatment is known as "best supportive care" (BSC). Although patients with best supportive care can feel better for some months, the cancer usually continues to grow.
Detailed Description: Durvalumab is a new type of drug for many types of cancer. Laboratory tests show that it works by allowing the immune system to detect 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 and has been studied in a few people and seems promising but it is not clear if it can offer better results than standard treatment alone. Tremelimumab is a new type of drug for various types of cancers. It works in a similar way to durvalumab and may improve the effect of durvalumab. This may also help slow the growth of the cancer cells or may cause cancer cells to die. Tremelimumab has been shown to shrink tumours in animals and has been studied in a few people and seems promising but it is not clear if it can offer better results than standard treatment alone when used with durvalumab. Combinations of durvalumab and tremelimumab have also been studied and when combined have been shown to increase tumour shrinkage in animals compared to either drug alone and while the combination has been studied in a few people, it is not clear if it can offer better results than standard treatment.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Tom Baker Cancer Centre, Calgary, Alberta, Canada
BCCA - Vancouver Cancer Centre, Vancouver, British Columbia, Canada
The Moncton Hospital, Moncton, New Brunswick, Canada
Dr. H. Bliss Murphy Cancer Centre, St. John's, Newfoundland and Labrador, Canada
QEII Health Sciences Centre, Halifax, Nova Scotia, Canada
Royal Victoria Regional Health Centre, Barrie, Ontario, Canada
Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston, Kingston, Ontario, Canada
London Regional Cancer Program, London, Ontario, Canada
Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
Algoma District Cancer Program, Sault Ste. Marie, Ontario, Canada
Odette Cancer Centre, Toronto, Ontario, Canada
University Health Network, Toronto, Ontario, Canada
Windsor Regional Cancer Centre, Windsor, Ontario, Canada
Hopital Charles LeMoyne, Greenfield Park, Quebec, Canada
Hopital de la Cite-de-la-Sante, Laval, Quebec, Canada
L'Hotel-Dieu de Levis, Levis, Quebec, Canada
CHUM - Hopital Notre-Dame, Montreal, Quebec, Canada
The Jewish General Hospital, Montreal, Quebec, Canada
Centre Integre Universitaire De Sante Et De Services, Montreal, Quebec, Canada
CHUQ-Pavillon Hotel-Dieu de Quebec, Quebec City, Quebec, Canada
Centre hospitalier universitaire de Sherbrooke, Sherbrooke, Quebec, Canada
Centre hospitalier regional de Trois-Rivieres, Trois-Rivieres, Quebec, Canada
Allan Blair Cancer Centre, Regina, Saskatchewan, Canada
Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada
Name: Eric Chen
Affiliation: Univ. Health Network-Princess Margaret Hospital, Toronto ON Canada
Role: STUDY_CHAIR