NCT02537418

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

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: Canadian Cancer Trials Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Solid Malignancies

Interventions

Type	Name	Description
DRUG	durvalumab
DRUG	tremelimumab

Timeline

• Start date: 2015-10-16
• Primary completion: 2018-07-20
• Completion: 2026-12-31
• First posted: 2015-09-01
• Last updated: 2026-03-27

Locations

7 sites across 1 country: Canada