A Phase 1b/2 Safety and Tolerability of MEDI6469 in Combination With Therapeutic Immune Agents or Monoclonal Antibodies
Conditions
Advanced Solid Tumors - Aggressive B-cell Lymphomas
Conditions: official terms
Aggression - Lymphoma, B-Cell
Conditions: Keywords
Advanced Solid tumors, Diffuse Large B-cell Lymphoma, programmed death 1, programmed dealth ligand 1, cytotoxic T-lymphocyte-associated antigen-4, OX40 ligand
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: MEDI6469/tremelimumab Type: Biological
Name: MEDI6469/MEDI4736 Type: Biological
Name: MEDI6469/rituximab Type: Biological
Name: MEDI6469 Type: Biological
Overall Status
Recruiting
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, or rituximab in subjects with either advanced solid tumors or diffuse large B-cell lymphoma (DLBCL). Tremelimumab and MEDI4736 will be tested with MEDI6469 in a set of subjects with advanced solid tumors while rituximab will be tested with MEDI6469 in subjects with DLBCL. MEDI6469 will be tested as monotherapy in subjects with advanced solid tumors.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- 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 Criteria:

- 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
Locations
Research Site
Scottsdale, Arizona, United States
Status: Recruiting
Research Site
Sacramento, California, United States
Status: Recruiting
Research Site
Santa Monica, California, United States
Status: Not yet recruiting
Research Site
Washington, District of Columbia, United States
Status: Recruiting
Research Site
Tampa, Florida, United States
Status: Recruiting
Research Site
Chicago, Illinois, United States
Status: Recruiting
Research Site
Detroit, Michigan, United States
Status: Recruiting
Research Site
Las Vegas, Nevada, United States
Status: Recruiting
Research Site
Hackensack, New Jersey, United States
Status: Recruiting
Research Site
Huntersville, North Carolina, United States
Status: Recruiting
Research Site
Portland, Oregon, United States
Status: Recruiting
Research Site
Memphis, Tennessee, United States
Status: Recruiting
Start Date
August 2014
Completion Date
October 2017
Sponsors
MedImmune LLC
Source
MedImmune LLC
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page