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Checkpoint Inhibitor
Nivolumab for Cancer
Phase 1
Recruiting
Led By Hussein A Tawbi
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Creatinine ULN OR glomerular filtration rate (GFR) >= 30 mL/min (if using the Cockcroft-Gault formula)
Patients with a malignancy for which a PD-1/PD-L1 inhibitor has been approved in the adjuvant setting
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 100 days
Awards & highlights
Study Summary
This trial is testing nivolumab as a treatment for cancer and autoimmune disorders. It will study the side effects of the drug and how well it works.
Who is the study for?
Adults with advanced or inoperable cancer and an autoimmune disorder (like lupus, rheumatoid arthritis, or multiple sclerosis) can join this trial. They should have a life expectancy over 12 weeks, be relatively active (ECOG 0-2), and have not had certain treatments recently. Those with controlled hepatitis B/C are eligible; however, pregnant women must use contraception.Check my eligibility
What is being tested?
The trial is testing Nivolumab's effectiveness and safety for patients who have both cancer and autoimmune diseases. It's a phase Ib study to see how well the immune system responds to this monoclonal antibody treatment in attacking cancer cells that spread or cannot be surgically removed.See study design
What are the potential side effects?
Nivolumab may cause immune-related side effects such as inflammation of organs, potential worsening of autoimmune conditions, fatigue, infusion reactions like fever or chills, skin rash, digestive issues like diarrhea or liver enzyme changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function, measured by creatinine level or GFR, is within the normal range.
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I have a cancer type that can be treated with PD-1/PD-L1 inhibitors.
Select...
I have received treatments like high-dose IL-2, IFN, or CTLA-4.
Select...
My hepatitis B is under control with undetectable viral load on treatment.
Select...
I am 18 years old or older.
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My cancer is confirmed, cannot be surgically removed, and has spread.
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I can take care of myself but might not be able to do heavy physical work.
Select...
My cancer responds to specific immune therapy drugs.
Select...
I had hepatitis C but have been treated and now have no detectable virus.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 100 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 100 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in disease assessments
Changes in serum chemokines and circulating immune cells over time
Clinical measures of interest
+3 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%
Hypertension
7%
Bronchitis
7%
Chills
7%
Hyperkalaemia
7%
Dehydration
7%
Hyperglycaemia
7%
Blood alkaline phosphatase increased
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Malaise
5%
Pain
5%
Musculoskeletal chest 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%
Malignant pleural effusion
2%
Sepsis
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Neoplasm progression
1%
Pericardial effusion malignant
1%
Small intestinal haemorrhage
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Atrial flutter
1%
Femur fracture
1%
Bone pain
1%
Circulatory collapse
1%
Hypercalcaemia
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 Treatment2 Interventions
Patients receive nivolumab IV over 30 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood, CSF, tissue, stool, and urine samples throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1730
Nivolumab
2014
Completed Phase 3
~4750
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,662 Previous Clinical Trials
40,925,773 Total Patients Enrolled
2 Trials studying Autoimmune Diseases
10,930 Patients Enrolled for Autoimmune Diseases
Hussein A TawbiPrincipal InvestigatorUniversity of Texas MD Anderson Cancer Center LAO
4 Previous Clinical Trials
183 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this endeavor currently have the capacity to enroll participants?
"Indeed, according to clinicaltrials.gov the current phase of this trial is participant recruitment which launched on April 4th 2019 and was most recently updated November 11th 2022. 300 individuals are needed from 42 different medical sites."
Answered by AI
What is the aggregate number of people participating in this research?
"This clinical study necessitates 300 participants that meet the pre-defined conditions for enrollment. Patients will be able to join the trial at University of Kansas Health System Saint Francis Campus in Topeka, Connecticut and Yale University in New Haven, Illinois amongst other sites."
Answered by AI
Is this endeavor an unprecedented medical investigation?
"Presently, there are 717 active trials of Nivolumab occurring in 49 countries and 2356 cities. This drug was first tested back in 2012 by Ono Pharmaceutical Co Ltd., with a total of 659 participants completing the Phase 1 & 2 stages. Since then, 259 studies have concluded their research."
Answered by AI
What evidence exists regarding the use of Nivolumab in prior medical tests?
"Currently, Nivolumab is being studied in a total of 717 clinical trials. Out of these experiments, 82 are at the Phase 3 stage and 40281 medical sites have been selected as venues for this research. The majority of studies are based out Basel BE."
Answered by AI
How many centers are administering this investigation?
"The trial is currently underway at 42 medical centres located in cities such as Topeka, New Haven and Kansas City. To limit any potential travel burden incurred by participants, it's crucial to select the nearest clinic when enrolling in this study."
Answered by AI
Is there evidence that Nivolumab can be taken without causing detrimental effects?
"The clinical data available on Nivolumab's safety and efficacy is limited, resulting in a score of 1."
Answered by AI
Who else is applying?
What state do they live in?
Other
Virginia
Georgia
Missouri
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Stanford Cancer Institute Palo Alto
Lawrence Memorial Hospital
Huntsman Cancer Institute/University of Utah
Other
How many prior treatments have patients received?
0
3+
Why did patients apply to this trial?
My Sjogrens is getting worse and there are no drugs that can help me. I've had Sjogren's for over forty years and am acquiring related conditions, like transverse myelitis and leukopenia. If there is a chance of slowing down or stopping progression, this would be the time.
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Average response time
- < 1 Day
Most responsive sites:
- Huntsman Cancer Institute/University of Utah: < 24 hours
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