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 (CPDR001X2105)
- Conditions
- bloodcell cancerbonemarrow cancer. AML: Acute myeloide leukemiaMDS: Myelodysplasia10024324
- Registration Number
- NL-OMON55557
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 5
1. Male or female patients * 18 years of age with
ARM 1-2-3 :
* Refractory/relapsed AML following *1 prior therapies
* De novo AML patients who are are suitable for treatment with decitabine
(patients who are suitable for standard induction chemotherapy and willing to
receive it are excluded)
* Intermediate or high risk MDS or MDS/MPN, including CMML
Arm 4a & 5a:
* Relapsed/refractory AML following *1 prior therapies who have relapsed or
exhibited refractory disease (primary failure)
Arm 4b & 5b:
* Intermediate or High risk MDS patients or MDS/MPN, including CMML who have
failed hypomethylating agent therapy.
Arm 6a
* Newly diagnosed AML patients who are suitable for treatment with azacitidine
Arm 6b :
* Intermediate or high-risk MDS or MDS/MPN, including CMML
2. ECOG performance status 0-1-2
3. Candidate for serial bone marrow aspirate and/or biopsy according to the
institutions guidelines and be willing to undergo the planned bone marrow
aspirate and/biopsy according to protocol.
1. Arms 1-2-3 or Arm 6 : Prior decitabine or hypomethylating agent treatment
for AML or MDS.
2. Impaired cardiac function or clinically significant cardiac disease. See
protocol page 32 for details.
3. HIV, active hepatitis B, C. See protocol page 32-33 for details.
4. Active, known or suspected autoimmune disease. See protocol page 33 for
details.
5. History of, or current drug-induced interstitial lung disease or pneumonitis
grade * 2.
6. 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. See protocol page 33 for more details.
7. Patients who discontinued prior TIM-3 directed therapy due to a treatment
related toxicity should not be included in the TIM-3 containing arms of the
study.
8. Treatment with cytotoxic or targeted antineoplastics within 3 weeks of
initiation of study treatment. See protocol page 33 for details.
9. 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.
10. Live vaccine against infectious disease within 4 weeks of study treatment.
11. Pregnancy, lactation, insufficient contraception for females of
childbearing potential and males.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Adverse events. Dose Limiting Toxicities (DLTs).</p><br>
- Secondary Outcome Measures
Name Time Method <p>ORR (Objective response rate), BOR (Best overall response), PFS (Progression<br /><br>free survival), TTP (Time to progression), DOR (Duration of response). PK<br /><br>parameters. Anti-PDR001 and anti-MBG453 antibodies.</p><br>