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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

This multicenter, open-label, Phase I study will evaluate the safety, efficacy, and pharmacokinetics of atezolizumab alone or in combination with daratumumab and/or various immunomodulatory agents in participants with MM who have relapsed or who have undergone autologous stem cell transplantation (ASCT). The planned duration of this study is approximately 36 months. Cycle length will be 21 days in Cohorts A to C and 28 days in Cohorts D to F.

Official Title

A Phase Ib Study of the Safety and Pharmacokinetics of Atezolizumab (Anti-PD-L1 Antibody) Alone or in Combination With an Immunomodulatory Drug and/or Daratumumab in Patients With Multiple Myeloma (Relapsed/Refractory and Post-Autologous Stem Cell Transplantation)

Keywords

Multiple Myeloma Antibodies Immunoglobulins Lenalidomide Thalidomide Antibodies, Monoclonal Pomalidomide Daratumumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • Previous diagnosis of MM with objective evidence of measurable disease
  • Willing and able to undergo bone marrow aspiration and biopsy tissue sample collection during screening and on study
  • Eastern Cooperative Oncology Group (ECOG) performance status score less than or equal to (</=) 2
  • Left ventricular ejection fraction (LVEF) greater than or equal to (>/=) 40 percent(%)
  • Total bilirubin </=2 times the ULN
  • Creatinine </=2.0 milligrams per deciliter (mg/dL), with creatinine clearance (CrCl)using the Cockcroft-Gault formula >/=40 milliliters per minute (mL/min) or 60 mL/min for those who receive lenalidomide
  • Corrected calcium at or below ULN
  • Transaminase levels </=2.5 times the upper limit of normal (ULN)
  • Receipt of >/=1 but not more than 3 prior lines of therapy (Cohorts A, B, C, D1, D2,E)
  • Receipt of >/=2 prior lines of therapy and progressed on treatment with an anti-CD38 monoclonal antibody (Cohort D3)
  • Receipt of >/=4 lines of prior therapy (Cohort F)
  • Absolute neutrophil count (ANC) >/=1000 cells per microliter (cells/mcL) (Cohorts A,B, D, E, F)
  • Platelet count >/=50,000 cells/mcL, or >/=30,000 cells/mcL if more than 50% bone marrow involvement (Cohorts A, B, D, E, F)
  • All participants who are prescribed lenalidomide or pomalidomide must be counseled at a minimum of every 21-28 days about pregnancy precautions and risks of fetal exposure(Cohorts B, C, E, F)
  • Agree to be registered in and comply with all requirements of the Revlimid Risk Evaluation and Mitigation Strategy (REMS) program (Cohorts B, C, E)
  • Agree to be registered in and comply with all requirements of the Pomalyst REMS program (Cohort F)
  • Sufficient recovery from first or second ASCT within 60-120 days of transplant (Cohort C)
  • Off antibiotic/antifungal therapy for >/=14 days (Cohort C)
  • Completion of any prior radiotherapy (Cohort C)
  • ANC >/=1500 cells/mcL (Cohort C)

You CAN'T join if...

  • Other malignancy within 2 years prior to screening, with some exceptions
  • Prior therapy with atezolizumab or other immunotherapies including CD137 agonists,anti-programmed death (PD)-1, anti-cytotoxic T-lymphocyte associated protein 4(CTLA-4), and anti-PD-L1 therapeutic antibodies
  • Uncontrolled cancer pain
  • Treatment with any investigational drug within 30 days or 5 half-lives of the investigational drug, whichever is longer
  • Known hypersensitivity to study drug and/or drug class
  • History of autoimmune disease except for controlled, treated thyroidism or Type 1 diabetes
  • Prior systemic anti-myeloma therapy within 14 days of Cycle 1 Day 1
  • Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes(POEMS) syndrome
  • Plasma cell leukemia (greater than 2,000 cells/mcL of circulating plasma cells by standard differential)
  • Immunosuppressive therapy within 6 weeks of Cycle 1 Day 1
  • Daily corticosteroid requirement within 2 weeks of Cycle 1 Day 1
  • Prior allogeneic stem cell transplant or solid organ transplant
  • Active hepatitis B, active hepatitis C, or positive for human immunodeficiency virus(HIV)
  • Uncontrolled, clinically significant pulmonary disease (for example, chronic obstructive pulmonary disease, pulmonary hypertension, idiopathic pulmonary fibrosis)that in the opinion of the investigator would put the participant at significant risk for pulmonary complications during the study
  • History of pneumonitis
  • Uncontrolled intercurrent illness including but not limited to uncontrolled infection,disseminated intravascular coagulation, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant or breastfeeding females
  • Inability to tolerate thromboprophylaxis (Cohorts B, C, E, F)
  • Evidence of progressive MM compared to pretransplant evaluation (Cohort C)
  • Prior treatment with anti-CD38 therapy including daratumumab (Cohorts D1, D2, E, F)

Locations

  • Scripps Clinic Torrey Pines accepting new patients
    La Jolla, California, 92037, United States
  • Mayo Clinic Can Ctr accepting new patients
    Scottsdale, Arizona, 85259, United States
  • Huntsman Cancer Institute accepting new patients
    Salt Lake City, Utah, 84132-0001, United States
  • Fred Hutchinson Cancer Research Center not yet accepting patients
    Seattle, Washington, 98109, United States
  • Texas Oncology-Baylor Sammons Cancer Center accepting new patients
    Dallas, Texas, 75246, United States
  • Houston Methodist Cancer Center not yet accepting patients
    Houston, Texas, 77030, United States
  • University Of Arkansas not yet accepting patients
    Little Rock, Arkansas, 72205, United States
  • Washington University School of Medicine accepting new patients
    Saint Louis, Missouri, 63110, United States
  • University of Wisconsin-Madison - Carbone Cancer Center not yet accepting patients
    Madison, Wisconsin, 53792, United States
  • University of Louisville not yet accepting patients
    Louisville, Kentucky, 40202-1798, United States
  • University of Alabama at Birmingham accepting new patients
    Birmingham, Alabama, 35249, United States
  • University of Cincinnati not yet accepting patients
    Cincinnati, Ohio, 45267, United States
  • Univ of Michigan Medical Ctr accepting new patients
    Ann Arbor, Michigan, 48109-0718, United States
  • Karmanos Cancer Institute. accepting new patients
    Detroit, Michigan, 48201, United States
  • The Ohio State University accepting new patients
    Columbus, Ohio, 43210, United States
  • Emory Univ Winship Cancer Inst accepting new patients
    Atlanta, Georgia, 30322, United States
  • Mayo Clinic Hospital - Florida not yet accepting patients
    Jacksonville, Florida, 32224, United States
  • Swedish Cancer Institute not yet accepting patients
    Cary, North Carolina, 27513, United States
  • VCU Medical Center not yet accepting patients
    Richmond, Virginia, 23292, United States
  • The Johns Hopkins Hospital accepting new patients
    Baltimore, Maryland, 21287, United States
  • Memorial Sloan-Kettering Cancer Center not yet accepting patients
    New York, New York, 10065, United States
  • Mount SInai Medical Center accepting new patients
    New York, New York, 10029, United States
  • Norwalk Hospital not yet accepting patients
    Norwalk, Connecticut, 06856, United States
  • Yale University accepting new patients
    New Haven, Connecticut, 06511, United States
  • Lifespan Cancer Institute not yet accepting patients
    Providence, Rhode Island, 02905, United States
  • Massachusetts General Hospital accepting new patients
    Boston, Massachusetts, 02114, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT02431208
Phase
Phase 1
Lead Scientist
Sandy Wong
Study Type
Interventional
Last Updated
September 1, 2017
I’m interested in this study!