A clinical trial in patients with renal cell cancer that have had at least one, but no more than three prior cancer treatments and their cancer has gotten worse or did not respond. The study is investigating the safety, tolerability, and clinical activity of investigational drugs MEDI0680 and Durvalumab. The study will look at the effect of these two drugs when given to patients in combination (given together) versus nivolumab given alone.
- Conditions
- clear-cell renal cell carcinomaMedDRA version: 20.0Level: LLTClassification code 10038407Term: Renal cell cancerSystem Organ Class: 100000072939Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-000323-43-GB
- Lead Sponsor
- MedImmune, LLC, a wholly-owned subsidiary of AstraZeneca PLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 96
-Must be 18 years or older
-Eastern Cooperative Oncology Group performance status of 0-1
-Adequate organ function
-No more than 1 prior line of therapy
For complete list of inclusion criteria please refer to the protocol
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 36
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60
-Concurrent enrollment in another clinical study, unless in follow-up period or it is an observational study
-Concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment
-Prior treatment with immunotherapy
For complete list of exclusion criteria please refer to the protocol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method