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



Status:Recruiting
Conditions:Blood Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Hematology, Hematology, Hematology, Leukemia
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:6/22/2018
Start Date:July 6, 2017
End Date:April 1, 2020
Contact:Novartis Pharmaceuticals
Email:Novartis.email@novartis.com
Phone:1-888-669-6682

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Phase 1b, Multi-arm, Open-label Study of PDR001 and/or MBG453 in Combination With Decitabine in Patients With Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome

To characterize the safety and tolerability of 1) MBG453 as a single agent or in combination
with PDR001 or 2) PDR001 and/or MBG453 in combination with decitabine in AML and high risk
MDS patients, and to identify recommended doses for future studies.


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:

Arms 1-3:

- Refractory/relapsed AML following ≥1 prior therapies and are deemed by the
investigator not to be candidates for standard therapy, including re-induction
with cytarabine or other established chemotherapy regimens for patients with AML
(patients who are suitable for standard re-induction chemotherapy or
hematopoietic stem cell transplantation and willing to receive it are excluded)

- De novo AML patients who are suitable for treatment with decitabine (patients who
are suitable for standard induction chemotherapy or hematopoietic stem cell
transplantation and willing to receive it are excluded)

- High risk MDS (patients who are suitable for standard re-induction chemotherapy
or hematopoietic stem cell transplantation and willing to receive it are
excluded)

Arms 4-5:

- Refractory / relapsed AML following ≥1 prior therapies (Arms 4a & 5a)

- High risk MDS who have failed hypomethylating agent therapy (Arms 4b & 5b) (Note:
hypomethylating agent failure is defined as progressive disease on
hypomethylating agent therapy or lack of clinically meaningful response as deemed
by investigator after at least 4 cycles of hypomethylating agent therapy.)

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 institutions guidelines and be willing to undergo a bone marrow aspirate
and/biopsy at screening, during and at the end of therapy on this study. Exceptions
may be considered after documented discussion with Novartis.

5. Arms 1-3: Patients must be fit for standard treatment with decitabine as determined by
the investigator and as per local decitabine package insert.
We found this trial at
4
sites
Portland, Oregon 97228
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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Portland, OR
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Boston, Massachusetts 02118
Principal Investigator: Andrew M. Brunner
Phone: 617-726-5131
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Boston, MA
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Houston, Texas 77030
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Houston, TX
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Melbourne, Victoria
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Melbourne,
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