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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Best overall response rate (ORR)
Secondary outcome measures
Duration of response
Incidence of adverse events
Overall survival
+1 more

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533
57%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Pyrexia
21%
Neutropenia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Dry skin
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Nasopharyngitis
8%
Lacrimation increased
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Chills
7%
Hyperkalaemia
7%
Hypertension
7%
Bronchitis
7%
Dehydration
7%
Blood alkaline phosphatase increased
7%
Hyperglycaemia
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Hypotension
5%
Pain
5%
Malaise
5%
Musculoskeletal chest pain
5%
Rash maculo-papular
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Sepsis
2%
Malignant pleural effusion
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Pericardial effusion malignant
1%
Pneumothorax
1%
Atrial flutter
1%
Bone pain
1%
Small intestinal haemorrhage
1%
Bronchial obstruction
1%
Femur fracture
1%
Syncope
1%
Hypercalcaemia
1%
Confusional state
1%
Cancer pain
1%
Neoplasm progression
1%
Circulatory collapse
1%
Superior vena cava syndrome
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab

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
~4750

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,749 Previous Clinical Trials
1,838,624 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,650 Previous Clinical Trials
4,130,812 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
Marginal Zone Lymphoma Research Study Groups: Treatment (nivolumab)
Marginal Zone Lymphoma 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
~3 spots leftby Apr 2025
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