Status:
TERMINATED
A Phase 1b/2 Safety and Tolerability Study of MEDI6469 in Combination With Therapeutic Immune Agents or Monoclonal Antibodies
Lead Sponsor:
MedImmune LLC
Conditions:
Advanced Solid Tumors
Aggressive B-cell Lymphomas
Eligibility:
All Genders
18-99 years
Phase:
PHASE1
PHASE2
Brief Summary
The main purpose of this study is to determine the best dose of MEDI6469 that is safe and tolerable when given as monotherapy and in combination with tremelimumab, MEDI4736 (durvalumab), or rituximab ...
Eligibility Criteria
Inclusion
- Adults \>/= 18 years old
- Histologically or cytologically confirmed advanced solid tumors that are refractory to standard therapy or for which no standard therapy exists (Monotherapy and in Cohorts A and B)
- At least one lesion measurable by RECIST not previously irradiated (Monotherapy and in Cohorts A and B)
- Histologically confirmed DLBCL(Cohort C)
- Adequate organ and marrow function
- ECOG performance status of 0 or 1
- Willingness to provide consent for biopsy samples
Exclusion
- Prior exposure to immunotherapy (either as a single agent or in combination) including but not limited to CD137 or OX40 agonists, anti-CTLA-4, anti-PD-1, or anti-PD-L1, anti-PD-L2 antibody or pathway-targeting agents
- History of organ transplant that requires use of immunosuppressives
- History of primary immunodeficiency or tuberculosis
- Active or prior documented autoimmune disease within the past 3 years
- Active or chronic viral hepatitis or history of any type of hepatitis within the last 6 months
- Major surgical procedure within 30 days prior to the first dose of investigational product or still recovering from prior surgery
- Women who are pregnant or lactating
Key Trial Info
Start Date :
August 13 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 8 2016
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT02205333
Start Date
August 13 2014
End Date
April 8 2016
Last Update
June 28 2017
Active Locations (13)
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1
Research Site
Scottsdale, Arizona, United States, 85259
2
Research Site
Sacramento, California, United States, 95817
3
Research Site
Santa Monica, California, United States, 90404
4
Research Site
Washington D.C., District of Columbia, United States, 20007