Trial Outcomes & Findings for Study of Azacitidine in Combination With Pembrolizumab in R/R AML Patients and in Newly Diagnosed Older Patients (NCT NCT02845297)
NCT ID: NCT02845297
Last Updated: 2023-03-09
Results Overview
The primary objective is to determine the safe and tolerable dose for both the relapsed/refractory AML patients.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
67 participants
Primary outcome timeframe
3- 28 day cycles
Results posted on
2023-03-09
Participant Flow
40 participants started in phase 1 of the study followed by an additional 27 participants in phase 2
Participant milestones
| Measure |
Safety Run in Phase (Only Cohort 1)
The treatment of relapsed/refractory AML patients receiving azacitidine and pembrolizumab.
|
Cohort 2 (Newly Diagnosed Patients)
New diagnosed older patients (greater than or equal to 65 years of age) who are not candidates for intensive induction chemotherapy receiving azacitidine and pembrolizumab.
|
|---|---|---|
|
Phase 1 (2 Years)
STARTED
|
40
|
0
|
|
Phase 1 (2 Years)
COMPLETED
|
40
|
0
|
|
Phase 1 (2 Years)
NOT COMPLETED
|
0
|
0
|
|
Phase (2 Years)
STARTED
|
0
|
27
|
|
Phase (2 Years)
COMPLETED
|
0
|
27
|
|
Phase (2 Years)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Cohort 1: Relapsed/Refractory AML Patients
n=40 Participants
The treatment of relapsed and refractory AML patients.
pembrolizumab: Intravenous pembrolizumab
Azacitadine: Intravenous or subcutaneous
|
Cohort 2: Newly Diagnosed Older Patients Not Eligible for Intensive Chemo
n=27 Participants
The treatment of newly diagnosed AML patients (≥ 65 years) who are not candidates for intensive induction chemotherapy.
pembrolizumab: Intravenous pembrolizumab 200 mg every 3 weeks
Azacitadine: Intravenous or subcutaneous
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=40 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=67 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=40 Participants
|
0 Participants
n=27 Participants
|
22 Participants
n=67 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=40 Participants
|
27 Participants
n=27 Participants
|
45 Participants
n=67 Participants
|
|
Age, Continuous
|
65 years
n=40 Participants
|
75 years
n=27 Participants
|
70 years
n=67 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=40 Participants
|
3 Participants
n=27 Participants
|
21 Participants
n=67 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=40 Participants
|
24 Participants
n=27 Participants
|
46 Participants
n=67 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
40 Participants
n=40 Participants
|
27 Participants
n=27 Participants
|
67 Participants
n=67 Participants
|
PRIMARY outcome
Timeframe: 3- 28 day cyclesPopulation: This outcome was assessed only in Cohort 1.
The primary objective is to determine the safe and tolerable dose for both the relapsed/refractory AML patients.
Outcome measures
| Measure |
Cohort 1: Relapsed/Refractory AML Patients
n=40 Participants
Relapsed/refractory AML patients.
|
Cohort 2: Newly Diagnosed Older Patients Not Eligible for Intensive Chemo
New diagnosed older patients (greater than or equal to 65 years of age) who are not candidates for intensive induction chemotherapy.
|
|---|---|---|
|
Maximal Tolerable Dose of Pembrolizumab for Cohort 1
|
200 mg
|
—
|
SECONDARY outcome
Timeframe: 3-28 day cyclesResponse will be assessed using the International European LeukemiaNet Guidelines in AML63 and IWG Modified Response Criteria (2006) for CR and CRi. CR is bone marrow blasts \<5%; absence of circulating blasts; ANC \> or = 1, 000/mcL; platelet count \> or = 100,000/mcL. CRi is all CR criteria except for residual neutropenia (\<1,000/mcL) or thrombocytopenia (\<100,000/mcL).
Outcome measures
| Measure |
Cohort 1: Relapsed/Refractory AML Patients
n=40 Participants
Relapsed/refractory AML patients.
|
Cohort 2: Newly Diagnosed Older Patients Not Eligible for Intensive Chemo
n=27 Participants
New diagnosed older patients (greater than or equal to 65 years of age) who are not candidates for intensive induction chemotherapy.
|
|---|---|---|
|
Number of Participants Who Had Complete Remission/Complete Remission With Incomplete Recovery
|
5 Participants
|
13 Participants
|
Adverse Events
Cohort 1: Relapsed/Refractory AML Patients
Serious events: 4 serious events
Other events: 6 other events
Deaths: 39 deaths
Cohort 2: Newly Diagnosed Older Patients Not Eligible for Intensive Chemo
Serious events: 1 serious events
Other events: 0 other events
Deaths: 23 deaths
Serious adverse events
| Measure |
Cohort 1: Relapsed/Refractory AML Patients
n=40 participants at risk
The treatment of relapsed and refractory AML patients.
pembrolizumab: Intravenous pembrolizumab
Azacitadine: Intravenous or subcutaneous
|
Cohort 2: Newly Diagnosed Older Patients Not Eligible for Intensive Chemo
n=27 participants at risk
The treatment of newly diagnosed AML patients (≥ 65 years) who are not candidates for intensive induction chemotherapy.
pembrolizumab: Intravenous pembrolizumab
Azacitadine: Intravenous or subcutaneous
|
|---|---|---|
|
Infections and infestations
Sepsis
|
10.0%
4/40 • Adverse event data will be collected at the time of participant consent until 30 days from the end of treatment. Serious adverse events will be collected for 90 days after end of treatment. After documented disease progression each subject will be followed by telephone for overall survival until death, withdrawal of consent, or the end of the study, whichever occurs first. Adverse event assessment occurred for up to 2.5 years on average for all patients.
|
3.7%
1/27 • Adverse event data will be collected at the time of participant consent until 30 days from the end of treatment. Serious adverse events will be collected for 90 days after end of treatment. After documented disease progression each subject will be followed by telephone for overall survival until death, withdrawal of consent, or the end of the study, whichever occurs first. Adverse event assessment occurred for up to 2.5 years on average for all patients.
|
Other adverse events
| Measure |
Cohort 1: Relapsed/Refractory AML Patients
n=40 participants at risk
The treatment of relapsed and refractory AML patients.
pembrolizumab: Intravenous pembrolizumab
Azacitadine: Intravenous or subcutaneous
|
Cohort 2: Newly Diagnosed Older Patients Not Eligible for Intensive Chemo
n=27 participants at risk
The treatment of newly diagnosed AML patients (≥ 65 years) who are not candidates for intensive induction chemotherapy.
pembrolizumab: Intravenous pembrolizumab
Azacitadine: Intravenous or subcutaneous
|
|---|---|---|
|
Infections and infestations
Lung Infection
|
15.0%
6/40 • Adverse event data will be collected at the time of participant consent until 30 days from the end of treatment. Serious adverse events will be collected for 90 days after end of treatment. After documented disease progression each subject will be followed by telephone for overall survival until death, withdrawal of consent, or the end of the study, whichever occurs first. Adverse event assessment occurred for up to 2.5 years on average for all patients.
|
0.00%
0/27 • Adverse event data will be collected at the time of participant consent until 30 days from the end of treatment. Serious adverse events will be collected for 90 days after end of treatment. After documented disease progression each subject will be followed by telephone for overall survival until death, withdrawal of consent, or the end of the study, whichever occurs first. Adverse event assessment occurred for up to 2.5 years on average for all patients.
|
Additional Information
Dr. Ivana Gojo
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phone: 410-502-8775
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place