A Study of Atezolizumab Administered Alone or in Combination With Azacitidine in Participants With Myelodysplastic Syndromes
Status: | Suspended |
---|---|
Conditions: | Blood Cancer, Blood Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/24/2018 |
Start Date: | September 30, 2015 |
End Date: | March 31, 2019 |
A Phase Ib Study of the Safety and Pharmacology of Atezolizumab (Anti-PD-L1 Antibody) Administered Alone or in Combination With Azacitidine in Patients With Myelodysplastic Syndromes
This is a multicenter, open-label, Phase 1b study of atezolizumab (anti-programmed
death-ligand 1 [anti-PD-L1] monoclonal antibody) in participants who have hypomethylating
agent (HMA)-naïve myelodysplastic syndromes (MDS) and are International Prognostic Scoring
System-Revised (IPSS-R) intermediate/high/very high-risk, or have MDS relapsed or are
refractory (R/R) to prior HMA therapy. The primary objectives of this study are to determine
the safety and tolerability of atezolizumab therapy in these participant populations,
including treatment in combination with azacitidine.
death-ligand 1 [anti-PD-L1] monoclonal antibody) in participants who have hypomethylating
agent (HMA)-naïve myelodysplastic syndromes (MDS) and are International Prognostic Scoring
System-Revised (IPSS-R) intermediate/high/very high-risk, or have MDS relapsed or are
refractory (R/R) to prior HMA therapy. The primary objectives of this study are to determine
the safety and tolerability of atezolizumab therapy in these participant populations,
including treatment in combination with azacitidine.
Inclusion Criteria:
- Diagnosis of MDS (participants with therapy-related MDS are eligible)
- Eastern Cooperative Oncology Group (ECOG) performance status score less than or equal
to (=) 2
- Adequate end-organ function, as determined by laboratory tests obtained within 28 days
prior to the first dose of study drug
- Willing and able to undergo a pre-treatment bone marrow biopsy and subsequent
on-treatment bone marrow biopsies
- Women who are not postmenopausal or surgically sterile must have a negative serum
pregnancy test result within 28 days prior to initiation of study drug
- For women of childbearing potential and men: agreement to remain abstinent (refrain
from heterosexual intercourse) or use highly effective contraceptive measures
For participants in Cohorts A, A2, B, and B2:
- Progression at any time after initiation of azacitidine or decitabine treatment OR
- Failure to achieve complete or partial response or hematological improvement after at
least six 4-week cycles of azacitidine or either four 4-week or four 6-week cycles of
decitabine OR
- Relapse after initial complete or partial response or hematological improvement after
six 4-week cycles of azacitidine or either four 4-week or four 6-week cycles of
decitabine administered within the past 2 years
For participants in Cohorts C1 and C2:
- Must not have received prior treatment for MDS with any hypomethylating agent
- IPSS-R risk category of Intermediate, High, or Very High assessed at screening
Exclusion Criteria:
- Participants with a diagnosis of MDS secondary to paroxysmal nocturnal hemoglobinuria
(PNH), aplastic anemia, or another inherited bone marrow failure disorder
- Prior allogeneic stem cell transplant or solid organ transplant
- Pregnant or lactating, or intending to become pregnant during the study
- Investigational therapy within 28 days prior to initiation of study treatment
- Immunosuppressive therapy within 6 weeks of Cycle 1, Day 1
- Prior treatment with immune checkpoint blockade therapies (anti-cytotoxic
T-lymphocyte-associated protein 4 [CTLA-4], anti-programmed death-1 [PD-1] or
anti-PD-L1) or immune agonists (anti-cluster of differentiation [CD] 137, anti-CD40,
anti-OX40)
- Any other therapy or serious medical condition, as specified in the protocol, or
abnormality in clinical laboratory tests that, in the investigator's judgement,
precludes the participant's safe participation in and completion of the study
- Left ventricular ejection fraction (LVEF) = 40 percent (%) at screening
- Planned major surgery during the study or within 4 weeks of Cycle 1, Day 1
- History of idiopathic pulmonary fibrosis, organizing pneumonitis, drug-induced
pneumonitis, or idiopathic pneumonitis or evidence of active pneumonitis on screening
chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation
field (fibrosis) is permitted.
We found this trial at
15
sites
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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1100 Fairview Avenue North
Seattle, Washington 98109
Seattle, Washington 98109
(206) 667-5000
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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1240 Lee Street
Charlottesville, Virginia 22908
Charlottesville, Virginia 22908
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1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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3322 West End Avenue
Nashville, Tennessee 37203
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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101 South 42nd Street
Omaha, Nebraska 68198
Omaha, Nebraska 68198
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San Francisco, California 94115
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