Durvalumab With or Without Tremelimumab in Metastatic Castration Resistant Prostate Cancer

Official Title

A Phase II Study of Durvalumab (MEDI4736) With or Without Tremelimumab in Patients With Metastatic Castration Resistant Prostate Cancer

Summary:

The purpose of this study is to find out the effects of giving durvalumab alone or in combination with tremelimumab on this type of cancer. In addition, this study will look at the side effects of durvalumab when given alone or in combination with tremelimumab.

Trial Description

Primary Outcome:

  • Objective response rate measured by RECIST 1.1 and iRECIST
Secondary Outcome:
  • Response rate as time to PSA progression
  • Objective Disease progression
  • Number and severity of adverse events
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 stimulate 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 nearly 2000 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 nearly 1500 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. While the combination has been studied in 217 people, it is not clear if it can offer better results than standard treatment.

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society