Your session is about to expire
← Back to Search
Monoclonal Antibodies
Blinatumomab + Pembrolizumab for Leukemia
Phase 1 & 2
Waitlist Available
Led By Matthew Wieduwilt, M.D., P.h.D.
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Women of child-bearing potential and men with partners of child-bearing potential must agree to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication
Male subjects must agree to use a latex condom during sexual contact with females of childbearing potential even if they have had a successful vasectomy starting with the first dose of study therapy through 120 days after the last dose of study therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights
Study Summary
This trial is testing whether adding pembrolizumab to blinatumomab improves response rate in people with relapsed or refractory B-cell acute lymphoblastic leukemia.
Who is the study for?
Adults with relapsed or refractory B-cell acute lymphoblastic leukemia who have tried at least one therapy before can join. They must not be pregnant, agree to use birth control, and should not have had certain treatments or surgeries recently. People with heart issues, other cancers needing treatment, active infections like TB or hepatitis, HIV, recent vaccines, autoimmune diseases or lung problems are excluded.Check my eligibility
What is being tested?
The trial is testing if adding pembrolizumab to blinatumomab improves response in patients whose leukemia has returned after treatment or didn't respond to previous therapies. It's a two-part study: first part checks safety (Phase I) and second part measures effectiveness (Phase II).See study design
What are the potential side effects?
Possible side effects include immune system reactions that might affect organs; infusion-related symptoms; fatigue; increased risk of infections due to weakened defenses; potential for hormonal imbalances and changes in blood counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree to use two forms of birth control or abstain from sex during and up to 120 days after the study.
Select...
I agree to use a condom during sex with women who can have children, from the start of the study until 120 days after it ends.
Select...
My B-ALL has come back or didn't respond to treatment after at least 1 therapy.
Select...
My leukemia is Ph+ or BCR-ABL1+ and I cannot tolerate or didn't respond to at least one advanced TKI treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate (ORR)
Secondary outcome measures
2 year relapse-free survival
2-year overall survival
Complete Response Rate (CR)
+2 moreSide effects data
From 2022 Phase 3 trial • 1274 Patients • NCT0222089412%
Weight decreased
9%
Diarrhoea
9%
Aspartate aminotransferase increased
9%
Arthralgia
9%
Constipation
9%
Haemoptysis
9%
Hypothyroidism
9%
Decreased appetite
9%
Alanine aminotransferase increased
9%
Nasopharyngitis
9%
Bronchitis
6%
Anaemia
6%
Cough
6%
Asthenia
6%
Pruritus
6%
Pneumonia
6%
Headache
6%
Blood alkaline phosphatase increased
3%
Tumour associated fever
3%
Rash
3%
Leukopenia
3%
Hyperglycaemia
3%
Pneumonia bacterial
3%
Myalgia
3%
Subdural haemorrhage
3%
Nausea
3%
Malaise
3%
White blood cell count decreased
3%
Upper respiratory tract infection
3%
Hypertension
3%
Pyrexia
3%
Dyspnoea
3%
Back pain
3%
Chest pain
3%
Haematemesis
3%
Hyperthyroidism
3%
Lymph gland infection
3%
Upper gastrointestinal haemorrhage
3%
Oedema peripheral
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab Second Course
Pembrolizumab
Chemotherapy (SOC Treatment)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Blinatumomab + PembrolizumabExperimental Treatment2 Interventions
Drug: blinatumomab Cycle 1 Blinatumomab Day 1-7 Continuous IV infusion for 28 days (9 mcg/day) Blinatumomab Day 8-28 Continuous IV infusion for 28 days (28 mcg/day)
Cycle 2-5 Blinatumomab Day 1-28 Continuous IV infusion for 28 days (28 mcg/day)
Cycle length 42 days
Other Names:
Blincyto
Drug: pembrolizumab Cycle 1 Pembrolizumab Day 15 and 36 IV infusion over 30 minutes (200mg)
Cycle 2-5 Pembrolizumab Day 15 and 36 IV infusion over 30 minutes (200mg)
Other Names:
Keytruda
MK-3475
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pembrolizumab
2017
Completed Phase 3
~5750
blinatumomab
2017
Completed Phase 1
~40
Find a Location
Who is running the clinical trial?
AmgenIndustry Sponsor
1,371 Previous Clinical Trials
1,378,202 Total Patients Enrolled
University of California, San DiegoLead Sponsor
1,122 Previous Clinical Trials
1,521,028 Total Patients Enrolled
Matthew Wieduwilt, M.D., Ph.D.Lead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My organs are working well.I had a stem cell transplant from a donor within the last 5 years.I have been diagnosed with Burkitt lymphoma/leukemia.I agree to use two forms of birth control or abstain from sex during and up to 120 days after the study.I agree to use a condom during sex with women who can have children, from the start of the study until 120 days after it ends.My leukemia has spread to my brain or testicles.I have another cancer besides the one being studied, but it's not getting worse or needing treatment, except for certain skin cancers or cervical cancer that's been treated.I have an active TB infection.I have not received a live vaccine in the last 30 days.I have or had lung inflammation not caused by infection, treated with steroids.I haven't had chemotherapy or radiotherapy in the last 2 weeks and have recovered from any side effects.I had surgery less than 4 weeks ago or haven't fully recovered.My B-ALL has come back or didn't respond to treatment after at least 1 therapy.I have a history of a neurological disorder.My leukemia is Ph+ or BCR-ABL1+ and I cannot tolerate or didn't respond to at least one advanced TKI treatment.I haven't used GM-CSF or G-CSF in the last 2 weeks and won't use them during the study.I have previously received immunotherapy for my cancer.I was born with an immune system disorder.I have been diagnosed with interstitial lung disease.I have a known heart condition.I am HIV positive.
Research Study Groups:
This trial has the following groups:- Group 1: Blinatumomab + Pembrolizumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger