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Checkpoint Inhibitor

Nivolumab for Relapsed or Resistant Blood Cancers

Phase 2
Waitlist Available
Led By Andrew Cowan
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Relapsed, refractory, or detectable disease after treatment with chimeric antigen receptor T-cells
Diagnosis of specific tumor types including Non Hodgkin-lymphoma and Chronic lymphocytic leukemia with histopathologic or flow confirmation
Must not have
Known (human immunodeficiency virus [HIV]) seropositivity
Receipt of intervening therapy after CAR T-cell infusion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing the effectiveness of nivolumab for treating blood cancers that have relapsed, become resistant to treatment, or are detectable after CAR T cell therapy. Nivolumab is an immunotherapy that may help the body's immune system attack the cancer.

Who is the study for?
This trial is for adults with certain blood cancers like Non-Hodgkin's lymphoma and Chronic lymphocytic leukemia that have returned or didn't respond after CAR T-cell therapy. Participants must not be pregnant, agree to use contraception, and should not have HIV, active infections, or require immunosuppressive drugs.
What is being tested?
The study tests Nivolumab in patients whose hematologic malignancies relapsed or are detectable post CAR T-cell treatment. It's a phase II trial to see if this monoclonal antibody can help the immune system fight cancer by stopping tumor growth.
What are the potential side effects?
Nivolumab may cause immune-related side effects such as inflammation of organs, skin reactions, fatigue, respiratory issues like pneumonitis, hormonal gland problems (like thyroid), and infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer returned or didn't respond after CAR T-cell therapy.
Select...
I have been diagnosed with Non-Hodgkin lymphoma or Chronic lymphocytic leukemia.
Select...
I am over 18 and can understand and agree to the study's details.
Select...
My cancer can be measured and tracked.
Select...
I haven't had any treatments after my CAR T-cell therapy.
Select...
I can take care of myself and am up and about more than half of the day.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am HIV positive.
Select...
I have received treatment after my CAR T-cell therapy.
Select...
I do not have any infections that are currently uncontrolled.
Select...
I have had another cancer that has been in remission for less than a year.
Select...
I am experiencing symptoms of cytokine release syndrome.
Select...
My cancer has spread to my brain or spinal cord.
Select...
I have an active lung infection.
Select...
I haven't taken steroids or immunosuppressants in the last 14 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 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
Best overall response rate (ORR)
Secondary study objectives
Duration of response
Incidence of adverse events
Overall survival
+1 more

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717
80%
Fatigue
70%
Diarrhoea
70%
Headache
40%
Vomiting
40%
Aspartate aminotransferase increased
40%
Rash maculo-papular
40%
Alanine aminotransferase increased
40%
Lipase increased
30%
Partial seizures
30%
Hemiparesis
30%
Gait disturbance
30%
Fall
30%
Cough
30%
Dry skin
30%
Amylase increased
30%
Nausea
30%
Confusional state
20%
Malignant neoplasm progression
20%
Pyrexia
20%
Candida infection
20%
Mucosal infection
20%
Decreased appetite
20%
Back pain
20%
Dysphonia
20%
Hypotension
20%
Colitis
20%
Hyperthyroidism
20%
Oedema peripheral
20%
Muscular weakness
20%
Hypothyroidism
10%
Tinnitus
10%
Cushingoid
10%
Diabetic ketoacidosis
10%
Procedural haemorrhage
10%
Blood bilirubin increased
10%
Bradycardia
10%
Sinus tachycardia
10%
Hyperglycaemia
10%
Hypocalcaemia
10%
Neck pain
10%
Brain oedema
10%
Hydrocephalus
10%
Lethargy
10%
Seizure
10%
Hypertension
10%
Palpitations
10%
Cheilitis
10%
Presyncope
10%
Face oedema
10%
Oedema
10%
Conjunctivitis
10%
Enterocolitis infectious
10%
Oral candidiasis
10%
Pneumonia
10%
Sinusitis
10%
Staphylococcal infection
10%
Blood alkaline phosphatase increased
10%
Spinal pain
10%
Tremor
10%
Dizziness
10%
Dysarthria
10%
Urinary retention
10%
Dyspnoea exertional
10%
Nasal congestion
10%
Pneumonitis
10%
Dermatitis
10%
Erythema
10%
Rash
10%
Klebsiella infection
10%
Hypomagnesaemia
10%
Syncope
10%
Haemorrhage intracranial
10%
Pancreatitis
10%
Cholecystitis
10%
Upper respiratory tract infection
10%
Acute kidney injury
10%
Dermatitis bullous
10%
Lymphopenia
10%
Optic nerve disorder
10%
Visual impairment
10%
Dehydration
10%
Hypokalaemia
10%
Scoliosis
10%
Cognitive disorder
10%
Memory impairment
10%
Hallucination
10%
Insomnia
10%
Irritability
10%
Urinary incontinence
10%
Dyspnoea
10%
Dermatitis acneiform
10%
Pelvic venous thrombosis
10%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: Arm N1+I3
Cohort 2: Arm B
Part A Cohort 1c: Arm N3+RT+TMZ
Part A Cohort 1d: Arm N3+RT
Part B Cohort 1c: Arm N3+RT+TMZ
Part B Cohort 1d: Arm N3+RT
Cohort 1: Arm N3
Cohort 1b: Arm N3+I1
Cohort 2: Arm N3

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: Treatment (nivolumab)Experimental Treatment1 Intervention
Patients receive nivolumab IV over 30 minutes on day 1. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2015
Completed Phase 3
~4010

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,829 Previous Clinical Trials
1,907,074 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,696 Previous Clinical Trials
4,099,051 Total Patients Enrolled
Andrew CowanPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
2 Previous Clinical Trials
28 Total Patients Enrolled

Media Library

Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04205409 — Phase 2
Chronic Lymphocytic Leukemia Research Study Groups: Treatment (nivolumab)
Chronic Lymphocytic Leukemia Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT04205409 — Phase 2
Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04205409 — Phase 2
~4 spots leftby Dec 2025
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