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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

Must not have

Allogeneic hematopoietic cell transplantation within 5 years of study drug administration

Burkitt lymphoma/leukemia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

No Placebo-Only Group

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.

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).

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 below

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I agree to use two forms of birth control or abstain from sex during and up to 120 days after the study.

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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.

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My B-ALL has come back or didn't respond to treatment after at least 1 therapy.

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My leukemia is Ph+ or BCR-ABL1+ and I cannot tolerate or didn't respond to at least one advanced TKI treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had a stem cell transplant from a donor within the last 5 years.

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I have been diagnosed with Burkitt lymphoma/leukemia.

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My leukemia has spread to my brain or testicles.

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I have an active TB infection.

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I have or had lung inflammation not caused by infection, treated with steroids.

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I had surgery less than 4 weeks ago or haven't fully recovered.

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I haven't used GM-CSF or G-CSF in the last 2 weeks and won't use them during the study.

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I have previously received immunotherapy for my cancer.

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I have a history of a neurological disorder.

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I was born with an immune system disorder.

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I have been diagnosed with interstitial lung disease.

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I have a known heart condition.

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I am HIV positive.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Response Rate (ORR)

Secondary study objectives

Number of participants with treatment-related adverse events as assessed by NCI CTCAE v4.0

Side effects data

From 2024 Phase 3 trial • 453 Patients • NCT03062358

36%

Aspartate aminotransferase increased

30%

Alanine aminotransferase increased

28%

Blood bilirubin increased

21%

Platelet count decreased

18%

Gamma-glutamyltransferase increased

17%

White blood cell count decreased

17%

Pyrexia

16%

Diarrhoea

15%

Anaemia

15%

Decreased appetite

15%

Rash

14%

Blood alkaline phosphatase increased

14%

Neutrophil count decreased

12%

Hypoalbuminaemia

12%

Pruritus

11%

Cough

11%

Upper respiratory tract infection

10%

Proteinuria

10%

Hypothyroidism

10%

Lymphocyte count decreased

Constipation

Arthralgia

Weight decreased

Abdominal pain

Nausea

Bilirubin conjugated increased

Insomnia

Asthenia

Fatigue

Hyperglycaemia

Hypokalaemia

Hyponatraemia

Hypoproteinaemia

Back pain

Hypertension

Vomiting

Abdominal distension

Blood lactate dehydrogenase increased

Hyperthyroidism

Ascites

Abdominal pain upper

Hepatitis B DNA increased

Malaise

Blood glucose increased

Blood creatinine increased

Upper gastrointestinal haemorrhage

Pneumonia

Dyspepsia

Gastrointestinal haemorrhage

Autoimmune hepatitis

Hepatic failure

Hepatitis E

Influenza

Sepsis

Tumour haemorrhage

Hepatic encephalopathy

Pneumonitis

Dysphonia

100%

80%

60%

40%

20%

Study treatment Arm

Pembrolizumab (First Course) + BSC

Placebo + BSC

Pembrolizumab Second Course

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active 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

~5890

blinatumomab

2017

Completed Phase 1

~40