A Study to Evaluate MEDI0562 in Combination With Immune Therapeutic Agents in Adult Subjects With Advanced Solid Tumors
Part of paid clinical trials in Santa Monica, California.
- Sponsor
- MedImmune LLC
- Study ID
- NCT02705482
- Phase
- PHASE1
- Status
- Completed
Conditions
- Select Advanced Solid Tumors
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 100 Years
- Healthy Volunteers
- Not accepted
Interventions
- MEDI0562 — BIOLOGICALSubjects will remain on treatment until unacceptable toxicity, documentation of progressive disease (PD), or development of other reason for treatment discontinuation.
- Tremelimumab — BIOLOGICALSubjects will remain on treatment until unacceptable toxicity, documentation of progressive disease (PD), or development of other reason for treatment discontinuation.
- Durvalumab — BIOLOGICALSubjects will remain on treatment until unacceptable toxicity, documentation of progressive disease (PD), or development of other reason for treatment discontinuation.
Study Details
The purpose of this study is to evaluate MEDI0562 in combination with immune therapeutic agents in adult subjects with select advanced solid tumors.
Key Dates
- Start date
- Mar 30, 2016
- Status verified
- Aug 2019
- Primary completion
- Aug 7, 2019
- Completion
- Aug 7, 2019
Study Design
- Enrollment
- 58 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm A: MEDI0562 and durvalumabMEDI0562 and durvalumab
- Experimental: Arm B: MEDI0562 and tremelimumabMEDI0562 and tremelimumab
Primary Outcome Measure
Safety as defined by the presence of adverse events (AE), serious adverse events (SAE), and dose limiting toxicities (DLT). [ Time Frame: From time of informed consent through 12 weeks after ending treatment with investigational product ]
Locations (9)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Research Site | Santa Monica | California | 90404 | - |
| Research Site | Chicago | Illinois | 60611 | - |
| Research Site | St Louis | Missouri | 63110 | - |
| Research Site | Albuquerque | New Mexico | 87106 | - |
| Research Site | New York | New York | 10032 | - |
| Research Site | Huntersville | North Carolina | 28078 | - |
| Research Site | Portland | Oregon | 97213 | - |
| Research Site | Nashville | Tennessee | 37203 | - |
| Research Site | Houston | Texas | 77030 | - |
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