Study of PDR001 and/or MBG453 in Combination With Decitabine in Patients With AML or High Risk MDS

Description

To characterize the safety and tolerability of PDR001 and/or MBG453 in combination with decitabine in relapsed/refractory AML patients, de novo AML patients who are not candidates for standard induction therapy, or high risk MDS patients, and to identify recommended doses for future studies.

Study Start Date

July, 06 2017

Estimated Completion Date

June 2019

Interventions

  • Drug: PDR001
  • Drug: MBG453
  • Drug: Decitabine

Study ID

Novartis -- CPDR001X2105

Status

Unknown

Trial ID

NCT03066648

Study Type

Interventional

Trial Phase

Phase 1

Enrollment Quota

70

Sponsor

Novartis

Inclusion Criteria

    1. Written informed consent must be obtained prior to any screening procedures 2. Male or female patients ? 18 years of age who present with one of the following:
  • Refractory/relapsed AML following ?1 prior therapies
  • De novo AML patients who are not candidates for standard therapy
  • High risk MDS 3. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ? 2 4. Patient must be a candidate for serial bone marrow aspirate and/or biopsy according to the institution's guidelines and be willing to undergo a bone marrow aspirate and/or biopsy at screening, during and at the end of therapy on this study. Exceptions may be considered after documented discussion with Novartis. 5. Patients must be fit for standard treatment with decitabine as determined by the investigator and as per local decitabine package insert. Other inclusion criteria included in the protocol might apply.

Exclusion Criteria

    1. Patients who have received prior decitabine or hypomethylating agent treatment for AML or MDS. 2. Patients with active, known or suspected autoimmune disease.Patients with vitiligo, type I diabetes, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment or conditions not expected to recur should not be excluded. 3. History of, or current drug-induced interstitial lung disease or pneumonitis grade ? 2. 4. Patients who discontinued prior PD-1 or PD-L1 directed therapy due to a treatment related toxicity should not be included in the PDR001 containing arms of the study. Patients previously exposed to anti-PD-1/PD-L1 treatment who are adequately treated for skin rash or with replacement therapy for endocrinopathies should not be excluded. 5. Treatment with cytotoxic or targeted antineoplastics within 3 weeks of initiation of study treatment. For patients that received antibodies or immunotherapies, 4 weeks is indicated as the washout period. Systemic antineoplastic therapy (including cytotoxic chemotherapy, alphainterferon, kinase inhibitors or other targeted small molecules, and toxin-immunoconjugates) or any experimental therapy within 14 days or 5 half-lives, whichever is shorter, before the first dose of study treatment. 6. Systemic chronic corticosteroid therapy (? 10 mg/day prednisone or equivalent) or any immunosuppressive therapy within 7 days of first dose of study treatment. Topical, inhaled, nasal and ophthalmic steroids are allowed. Other exclusion criteria included in the protocol might apply.

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (3)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Meghan Burke 617-726-5131 Mburke19@partners.org
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Meghan Burke 617-726-5131 Mburke19@partners.org
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Meghan Burke 617-726-5131 Mburke19@partners.org

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