Phase 1 Study to Evaluate MEDI4736 in Subjects With Myelodysplastic Syndrome
A Phase 1 Study to Evaluate the Safety and Tolerability of MEDI4736 as Monotherapy or in Combination With Tremelimumab With or Without Azacitidine in Subjects With Myelodysplastic Syndrome After Treatment With Hypomethylating Agents
1 other identifier
interventional
67
4 countries
21
Brief Summary
This is a multicenter, open-label, Phase 1 study to assess the safety and antitumor activity of MEDI4736 as Monotherapy or in Combination with Tremelimumab with or without Azacitidine in Subjects with myelodysplastic syndrome after treatment with hypomethylating agents
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2014
Longer than P75 for phase_1
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 14, 2014
CompletedFirst Posted
Study publicly available on registry
April 17, 2014
CompletedStudy Start
First participant enrolled
May 20, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2019
CompletedMay 10, 2019
May 1, 2019
4.9 years
April 14, 2014
May 9, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Subject's safety where no more than one out of six subjects experience DLTs at a given dose
DLT (MEDI4736 monotherapy only) assessment will be done by reviewing adverse events (AEs), serious adverse events (SAEs), laboratory evaluations, vital signs, physical examinations, and electrocardiogram (ECG) results. For monotherapy or combo w/aza AEs, SAEs, lab evaluations, vital signs, physical exams, ECGs will be done.
180 days
Subject's safety overall (monotherapy and combination therapies)
Overall safety assessments will be done by reviewing adverse events (AEs, serious adverse events (SAEs), laboratory evaluations, vital signs, physical examinations and electrocardiogram (ECG) results.
730 days
Secondary Outcomes (12)
Clinical outcome in terms of response: duration of response
2 years
Clinical outcome in terms of response: transfusion requirements
2 years
Clinical outcome in terms of response: progression-free survival (PFS)
2 years
Clinical outcome in terms of response: survival (OS)
2 years
Pharmacokinetics: MEDI4736 and tremelimumab concentrations in serum: peak concentration
1 year
- +7 more secondary outcomes
Study Arms (3)
MEDI4736 Evaluate MEDI4736 in MDS
EXPERIMENTALEvaluate MEDI4736 monotherapy and MEDI4736 in combination with azacitidine after monotherapy progression in MDS
MEDI4736 + tremelimumab
EXPERIMENTALEvaluate MEDI4736 in combination with tremelimumab
MEDI4736 + tremelimumab + azacitidine
EXPERIMENTALEvaluate MEDI4736 in combination with tremelimumab and azacitidine
Interventions
MEDI4736 will be administered by IV infusion
VIDAZA will be administered subcutaneously as described on the package insert VIDAZA will be administered in combination with MEDI4736 upon progression from MEDI4736 monotherapy
tremelimumab will be administered by IV infusion
Eligibility Criteria
You may qualify if:
- Adult male or female subjects with pathologically confirmed MDS who failed to respond, relapsed after an initial response, or were unable to tolerate hypomethylating agents, ECOG performance status of 0 - 2, and adequate organ and marrow function.
You may not qualify if:
- Concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment, prior MAb against CTLA-4, PD-1, or PD-L1, alllogenic or haploidentical transplant, current immunosuppressive medication or autoimmune or inflammatory disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedImmune LLClead
Study Sites (21)
Research Site
Scottsdale, Arizona, 85259, United States
Research Site
Los Angeles, California, 90095, United States
Research Site
New Haven, Connecticut, 06520-8063, United States
Research Site
Tampa, Florida, 33612, United States
Research Site
Atlanta, Georgia, 30322, United States
Research Site
Chicago, Illinois, 60637, United States
Research Site
Baltimore, Maryland, 21201, United States
Research Site
Boston, Massachusetts, 02215, United States
Research Site
Detroit, Michigan, 48201, United States
Research Site
Rochester, Minnesota, 55905, United States
Research Site
New York, New York, 10029, United States
Research Site
New York, New York, 10065, United States
Research Site
Greenville, South Carolina, 29601, United States
Research Site
Houston, Texas, 77030, United States
Research Site
San Antonio, Texas, 78229, United States
Research Site
Milwaukee, Wisconsin, 53226, United States
Research Site
Paris, 75475, France
Research Site
Dresden, 1307, Germany
Research Site
Brighton, BN2 5BE, United Kingdom
Research Site
London, SE5 9RS, United Kingdom
Research Site
Manchester, M20 4BX, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MedImmune LLC
MedImmune LLC
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2014
First Posted
April 17, 2014
Study Start
May 20, 2014
Primary Completion
April 30, 2019
Study Completion
April 30, 2019
Last Updated
May 10, 2019
Record last verified: 2019-05