Trial Outcomes & Findings for Pembrolizumab in Treating Minimal Residual Disease in Patients With Acute Lymphoblastic Leukemia (NCT NCT02767934)

NCT ID: NCT02767934

Last Updated: 2020-08-20

Results Overview

Will be defined as percentage of evaluable subjects who achieve a complete response. Will be evaluated with a Simon two-stage optimum design.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 12 participants
• Primary outcome timeframe: Up to 2 years
• Results posted on: 2020-08-20

Participant Flow

Participant milestones

Measure	Pembrolizumab Pembrolizumab for MRD in Adults with ALL
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pembrolizumab in Treating Minimal Residual Disease in Patients With Acute Lymphoblastic Leukemia

Baseline characteristics by cohort

Measure	Treatment (Pembrolizumab) n=12 Participants Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients achieving complete MRD response may receive up to 1 additional year of treatment at the discretion of the investigator. Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	52.5 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 2 years

Will be defined as percentage of evaluable subjects who achieve a complete response. Will be evaluated with a Simon two-stage optimum design.

Outcome measures

Measure	Pembrolizumab n=12 Participants Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients achieving complete MRD response may receive up to 1 additional year of treatment at the discretion of the investigator. Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV
Rate of Complete Minimal Residual Disease Response	1 Participants

SECONDARY outcome

Timeframe: Up to 2 years

Outcome measures

Measure	Pembrolizumab n=12 Participants Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients achieving complete MRD response may receive up to 1 additional year of treatment at the discretion of the investigator. Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV
Overall Survival	12.7 months Interval 5.9 to 30.4

SECONDARY outcome

Timeframe: Up to 2 years

Outcome measures

Measure	Pembrolizumab n=12 Participants Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for 2 years in the absence of disease progression or unacceptable toxicity. Patients achieving complete MRD response may receive up to 1 additional year of treatment at the discretion of the investigator. Laboratory Biomarker Analysis: Correlative studies Pembrolizumab: Given IV
Relapse-Free Survival	3.1 months Interval 1.2 to 30.4

Adverse Events

Pembrolizumab

Serious events: 1 serious events

Other events: 6 other events

Deaths: 5 deaths

Serious adverse events

Measure	Pembrolizumab n=12 participants at risk Pembrolizumab for MRD in Adults with ALL
Infections and infestations Bacteremia (acinetobacter ursingii, herbasprillum, achromobacter xylosoxidans)	8.3% 1/12 • Number of events 1 • From the time of consent through 30 days following cessation of treatment, an average of 3 months

Other adverse events

Measure	Pembrolizumab n=12 participants at risk Pembrolizumab for MRD in Adults with ALL
Injury, poisoning and procedural complications Infusion related reaction	8.3% 1/12 • Number of events 1 • From the time of consent through 30 days following cessation of treatment, an average of 3 months
Skin and subcutaneous tissue disorders Pruritus	8.3% 1/12 • Number of events 1 • From the time of consent through 30 days following cessation of treatment, an average of 3 months
Skin and subcutaneous tissue disorders Stevens-Johnson syndrome	8.3% 1/12 • Number of events 1 • From the time of consent through 30 days following cessation of treatment, an average of 3 months
Vascular disorders Hypertension	16.7% 2/12 • Number of events 3 • From the time of consent through 30 days following cessation of treatment, an average of 3 months
Investigations Alanine aminotransferase increased	8.3% 1/12 • Number of events 1 • From the time of consent through 30 days following cessation of treatment, an average of 3 months
Investigations Aspartate aminotransferase increased	8.3% 1/12 • Number of events 1 • From the time of consent through 30 days following cessation of treatment, an average of 3 months

Additional Information

Dr. Ryan Cassaday

University of Washington

Phone: 206-606-1202

Email: cassaday@seattlecca.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place