A Phase 1b Study of MEDI4736 in Combination With Tremelimumab in Subjects With Advanced Non-small Cell Lung Cancer
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- MedImmune LLC
- Study ID
- NCT02000947
- Phase
- PHASE1
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 101 Years
- Healthy Volunteers
- Not accepted
Interventions
- MEDI4736 — DRUGMEDI4736 is an anti-PD-L1 monoclonal antibody (MAb).
- Tremelimumab — DRUGTremelimumab is an anti-CTLA4 monoclonal antibody (mAb).
- tremelimumab — DRUGTremelimumab is an anti-CTLA4 monoclonal antibody (mAb).
Study Details
The purpose of this study is to determine if MEDI4736 will be adequately tolerated in combination with tremelimumab in subjects with advanced non-small cell lung cancer (NSCLC).
Key Dates
- Start date
- Oct 25, 2013
- Status verified
- Oct 2019
- Primary completion
- Sep 17, 2019
- Completion
- Sep 17, 2019
Study Design
- Enrollment
- 459 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Dose EscalationMEDI4736 and tremelimumab received by intravenous infusion.
- Experimental: Arm AMedi4736 and tremelimumab received by intravenous infusion
- Experimental: Arm BMEDI4736 and tremelimumab received by intravenous infusion
- Experimental: Arm CMEDI4736 and tremelimumab received by intravenous infursion
Primary Outcome Measure
Number of subjects reporting adverse events [ Time Frame: Screening through 90 days after the last dose of study medication ]
Locations (28)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Research Site | Birmingham | Alabama | 35294-3300 | - |
| Research Site | Tucson | Arizona | 85715 | - |
| Research Site | Los Angeles | California | 90025 | - |
| Research Site | Los Angeles | California | 90095 | - |
| Research Site | San Francisco | California | 94158 | - |
| Research Site | Aurora | Colorado | 80045 | - |
| Research Site | New Haven | Connecticut | 06510 | - |
| Research Site | Newark | Delaware | 19713 | - |
| Research Site | Tampa | Florida | 33612 | - |
| Research Site | Indianapolis | Indiana | 46202 | - |
| Research Site | Baltimore | Maryland | 21287 | - |
| Research Site | Boston | Massachusetts | 02114 | - |
| Research Site | Boston | Massachusetts | 02215 | - |
| Research Site | Ann Arbor | Michigan | 48109 | - |
| Research Site | Detroit | Michigan | 48201 | - |
| Research Site | St Louis | Missouri | 63110 | - |
| Research Site | Lebanon | New Hampshire | 03756 | - |
| Research Site | New York | New York | 10032 | - |
| Research Site | New York | New York | 10065 | - |
| Research Site | Huntersville | North Carolina | 28078 | - |
| Research Site | Columbus | Ohio | 43210 | - |
| Research Site | Portland | Oregon | 97213 | - |
| Research Site | Fort Worth | Texas | 76104 | - |
| Research Site | Houston | Texas | 77521 | - |
| Research Site | Tyler | Texas | 75702 | - |
| Research Site | Fairfax | Virginia | 22031 | - |
| Research Site | Seattle | Washington | 98109 | - |
| Research Site | Morgantown | West Virginia | 26506 | - |
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