Trial Search Results

A Study of Atezolizumab Administered Alone or in Combination With Azacitidine in Participants With Myelodysplastic Syndromes

The purpose of this study is to test the safety of the combination of an experimental drug (not yet approved by the U.S. Food and Drug Administration [FDA]) called ATEZOLIZUMAB and azacitidine (approved by the FDA) to find out what effects, good or bad, the combination of ATEZOLIZUMAB and azacitidine has on intermediate/high/very high-risk patients (IPSS-R) MDS patients who are either naive to HMAs or relapsed/refractory to prior HMA therapy. Atezolizumab will be evaluated as a single agent and in combination with azacitidine in the relapsed/refractory population. HMA-naive patients will receive atezolizumab in combination with azacitidine.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Hoffmann-La Roche

Stanford Investigator(s):

Intervention(s):

  • Drug: Atezolizumab
  • Drug: Azacitidine

Phase:

Phase 1

Eligibility


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 (
   - 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)
   - 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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting