Durvalumab and Tremelimumab and Best Supportive Care vs Best Supportive Care Alone in Patients With Advanced Colorectal Adenocarcinoma Refractory to Standard Therapies
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|ClinicalTrials.gov Identifier: NCT02870920|
Recruitment Status : Active, not recruiting
First Posted : August 17, 2016
Last Update Posted : September 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: Tremelimumab Drug: Durvalumab Other: Best Supportive Care||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||179 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||August 10, 2016|
|Actual Primary Completion Date :||October 18, 2018|
|Estimated Study Completion Date :||December 30, 2020|
Active Comparator: Best Supportive Care
Best supportive care available
Other: Best Supportive Care
Experimental: Durvalumab plus Tremelimumab and Best Supportive Care
Tremelimumab 75mg IV 60 minutes Day 1, cycles 1-4 Durvalumab 1500mg IV 60 minutes Day 1 every 28 days. Plus best supportive care
Other: Best Supportive Care
- Overall survival [ Time Frame: 24 months ]
- Progression-free survival defined as the time from randomization to the first objective documentation of disease progression or death due to any cause [ Time Frame: 24 months ]
- Objective response rate defined as the proportion of patients with a documented complete response and partial response based on RECIST 1.1 [ Time Frame: 24 months ]
- Number and severity of adverse events using the NCI Common Terminology Criteria for Adverse Events. [ Time Frame: 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02870920
|Study Chair:||Eric Chen||Univ. Health Network-Princess Margaret Hospital, Toronto ON Canada|