Durvalumab With or Without Tremelimumab in Advanced Incurable Solid Malignancies Given With or Without Standard Chemotherapy Regimens

Official Title

A Phase IB Study of Durvalumab (MEDI4736) With or Without Tremelimumab in Patients With Advanced Incurable Solid Malignancies Given With or Without Standard Chemotherapy Regimens

Summary:

The purpose of this study is to find the highest dose of durvalumab or of durvalumab with tremelimumab that can be tolerated without causing very severe side effects when receiving standard chemotherapy and to see what effects the study drugs has on this type of cancer. Patients may receive durvalumab alone or in combination with tremelimumab.

Trial Description

Primary Outcome:

  • Confirm the recommended phase II dose (RP2D) of durvalumab ± tremelimumab in patients receiving standard chemotherapy
Secondary Outcome:
  • Number of Participants with treatment-related adverse events as assessed by CTCAE v 4.0
  • Efficacy of durvalumab ± tremelimumab in patients receiving standard chemotherapy. Assessed by chest/abdomen/pelvis CT scan and other scans as necessary to document
  • Characterize the immunogenicity of durvalumab ± tremelimumab in patients receiving standard chemotherapy
The researchers doing this study are also interested in looking for markers that will help predict which patients are most likely to be helped by the study drugs, durvalumab and tremelimumab. This is done by starting at a dose lower than the one that does not cause side effects in animals. Participants are given durvalumab alone or durvalumab together with tremelimumab and are watched very closely to see what side effects they have and to make sure the side effects are not severe. If the side effects are not severe, then new participants will be given a higher dose of durvalumab together with tremelimumab. Participants joining this study later on will get higher doses of durvalumab together with tremelimumab than participants who join earlier. This will continue until a dose is found that causes severe but temporary side effects. Doses higher than that will not be given. The second purpose is to see if there are any differences in the side effects and the way durvalumab and tremelimumab are handled in your body when durvalumab is given together at the same time with tremelimumab compared to when durvalumab is given after tremelimumab. This is called dose level five.

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