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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 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.
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
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 moreSide effects data
From 2022 Phase 3 trial • 541 Patients • NCT0204153357%
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%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
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%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Bronchitis
7%
Blood alkaline phosphatase increased
7%
Chills
7%
Hypertension
7%
Dehydration
7%
Hyperkalaemia
7%
Hyperglycaemia
7%
Lymphocyte count decreased
7%
Anxiety
6%
Leukopenia
6%
Hypophosphataemia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Musculoskeletal chest pain
5%
Malaise
5%
Pain
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%
Hypercalcaemia
1%
Neoplasm progression
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Pericardial effusion malignant
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Circulatory collapse
1%
Bone pain
1%
Atrial flutter
1%
Bronchial obstruction
1%
Superior vena cava syndrome
1%
Syncope
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
1,738 Previous Clinical Trials
1,844,331 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,494 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what maladies is Nivolumab typically administered?
"Nivolumab can be effective at treating malignant growths, unresectable melanoma, and squamous cell carcinoma."
Answered by AI
Could you provide further insight on other trials centering around Nivolumab?
"Currently, 718 active clinical trials are investigating Nivolumab and 82 of these studies have progressed to phase 3. While most of the tests for this medication are taking place in Basel, 40280 more facilities around the world are also hosting research on it."
Answered by AI
Is Nivolumab a reliable and secure treatment option?
"Due to its Phase 2 designation, the perceived safety of Nivolumab was evaluated as a score of 2, which indicates that there is some evidence indicating it may be safe but not yet any data proving efficacy."
Answered by AI
Has there ever been a similar experiment to this clinical trial?
"According to records, Nivolumab is the focus of 718 currently active clinical trials across 49 countries and 2355 cities. The first study for this drug commenced in 2012 by Ono Pharmaceutical Co. Ltd., involving 659 patients during its Phase 1 & 2 approval process. Since then, 252 similar studies have been completed with varying outcomes."
Answered by AI
What is the scope of participation in this medical study?
"Affirmative. According to clinicaltrials.gov, this research study is currently recruiting for 20 participants at 1 location after first being posted on June 5th 2020 and last updated on August 16th 2022."
Answered by AI
Are there any available slots for participants in this research endeavor?
"Yes, clinicaltrials.gov data affirms that this medical study is actively recruiting participants, beginning with its original release on June 5th 2020 and most recently updated on August 16th 2022. The recruitment process will involve 20 individuals from 1 site."
Answered by AI
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