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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
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 moreSide effects data
From 2024 Phase 3 trial • 529 Patients • NCT0201771780%
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
2014
Completed Phase 3
~5220
Find a Location
Who is running the clinical trial?
University of WashingtonLead Sponsor
1,812 Previous Clinical Trials
1,913,767 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,681 Previous Clinical Trials
4,124,993 Total Patients Enrolled
Andrew CowanPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
2 Previous Clinical Trials
28 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer returned or didn't respond after CAR T-cell therapy.I have been diagnosed with Non-Hodgkin lymphoma or Chronic lymphocytic leukemia.I am HIV positive.I am over 18 and can understand and agree to the study's details.I am being treated for GVHD, but it's only on my skin and managed with creams.I have received treatment after my CAR T-cell therapy.I agree to use two forms of birth control during and for 8 months after the study.Your blood test results need to be in certain ranges.My cancer can be measured and tracked.You are currently taking other cancer medications or participating in experimental treatments.I have had another cancer that has been in remission for less than a year.I am experiencing symptoms of cytokine release syndrome.You are expected to live for more than 3 months.I do not have any infections that are currently uncontrolled.I have an autoimmune disease but don't need strong medication for it.My cancer has spread to my brain or spinal cord.I have an active lung infection.You have active hepatitis B or hepatitis C when you get screened for the study.I haven't taken steroids or immunosuppressants in the last 14 days.I haven't had any treatments after my CAR T-cell therapy.I can take care of myself and am up and about more than half of the day.I have had radiation therapy after receiving CAR T cell treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (nivolumab)
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.
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