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

Sponsor
Canadian Cancer Trials Group
Study ID
NCT02537418
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Solid Malignancies

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Oct 16, 2015
Status verified
Mar 2026
Primary completion
Jul 20, 2018
Completion
Dec 31, 2026

Study Design

Enrollment
153 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: durvalumab ± tremelimumab
    durvalumab; Day 1 every 3 weeks or 4 weeks tremelimumab; every 3-6 weeks for a total of 1-6 doses

Primary Outcome Measure

Confirm the recommended phase II dose (RP2D) of durvalumab ± tremelimumab in patients receiving standard chemotherapy [ Time Frame: 24 months ]

Related Studies