Nivolumab for Autoimmune Diseases

Phase-Based Estimates
1
Effectiveness
1
Safety
Roswell Park Cancer Institute, Buffalo, NY
Autoimmune Diseases+18 More
Nivolumab - Biological
Eligibility
18+
All Sexes
Eligible conditions
Autoimmune Diseases

Study Summary

This study is evaluating whether a type of immunotherapy may help treat cancer.

See full description

Eligible Conditions

  • Autoimmune Diseases
  • Libman-Sacks Disease
  • Multiple Sclerosis
  • Ileocolitis
  • Inflammatory Bowel Diseases
  • Scleroderma, Systemic
  • Cancer
  • Sicca Syndrome
  • Dermatomyositis
  • Scleroderma, Diffuse
  • Lupus Erythematosus, Systemic
  • Sjögren's Syndrome
  • Advanced Malignant Solid Neoplasm
  • Inflammatory Bowel Diseases (IBD)
  • Crohn Disease
  • Hematopoietic and Lymphoid Cell Neoplasm
  • Rheumatoid Arthritis
  • Metastatic Malignant Solid Neoplasm
  • Neoplasms
  • Sjogren's Syndrome
  • Systemic Lupus Erythematosus (SLE)
  • Ulcerative Colitis
  • Unresectable Malignant Solid Neoplasm

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Nivolumab will improve 6 primary outcomes in patients with Autoimmune Diseases. Measurement will happen over the course of Baseline up to 100 days.

Day 100
Change in disease assessments
Changes in serum chemokines and circulating immune cells over time
Up to 100 days
Clinical measures of interest
Gene expression in normal tissues
Incidence of adverse events
Overall response rate

Trial Safety

Safety Estimate

1 of 3

Compared to trials

Side Effects for

DOCETAXEL
Fatigue
40%
Neutropenia
32%
Anaemia
29%
Dyspnoea
29%
Decreased appetite
27%
Diarrhoea
26%
Nausea
25%
Alopecia
22%
Asthenia
21%
Cough
19%
Pyrexia
19%
Constipation
15%
Vomiting
13%
Neuropathy peripheral
12%
Myalgia
12%
Arthralgia
12%
Oedema peripheral
12%
Febrile neutropenia
10%
Mucosal inflammation
10%
Back pain
9%
Chest pain
9%
Dizziness
9%
Rash
9%
Hyperglycaemia
8%
Pneumonia
8%
Abdominal pain
7%
Malignant neoplasm progression
7%
Leukopenia
7%
Headache
7%
Haemoptysis
7%
White blood cell count decreased
6%
Neutrophil count decreased
6%
Paraesthesia
6%
Bone pain
5%
Musculoskeletal pain
5%
Insomnia
5%
Weight decreased
5%
Hypomagnesaemia
3%
Upper respiratory tract infection
3%
Bronchitis
3%
Infection
2%
Respiratory failure
2%
Musculoskeletal chest pain
2%
Atrial fibrillation
2%
Sepsis
2%
Pruritus
2%
Dehydration
2%
Cerebrovascular accident
2%
Pulmonary haemorrhage
2%
Lung infection
2%
Pulmonary embolism
2%
Neutropenic infection
1%
Skin infection
1%
Mental status changes
1%
Cardiac tamponade
1%
Enterocolitis infectious
1%
Tumour pain
1%
Aphasia
1%
Intestinal perforation
1%
Pleural effusion
1%
Goitre
1%
Superior vena cava syndrome
1%
Metastases to central nervous system
1%
Septic shock
1%
Confusional state
1%
Hypoglycaemia
1%
Bronchopneumonia
1%
Clostridium difficile colitis
1%
Chills
1%
Dysphonia
1%
Pneumothorax
1%
Oropharyngeal pain
1%
Hyponatraemia
1%
Delirium
1%
Arterial haemorrhage
1%
Chronic obstructive pulmonary disease
1%
Cardio-respiratory arrest
1%
Acute respiratory failure
1%
Stridor
1%
Febrile bone marrow aplasia
1%
Calculus ureteric
1%
Interstitial lung disease
1%
VIIth nerve paralysis
1%
Peripheral sensory neuropathy
1%
Pancytopenia
1%
Urinary tract infection
1%
Respiratory tract infection
1%
Dysphagia
0%
Ischaemic stroke
0%
Hypothyroidism
0%
Atrial thrombosis
0%
Lower respiratory tract infection
0%
General physical health deterioration
0%
Sudden death
0%
Spinal cord compression
0%
Hypophosphataemia
0%
Generalised tonic-clonic seizure
0%
Sinus bradycardia
0%
Hypercalcaemia
0%
Pneumonitis
0%
Myasthenic syndrome
0%
Peripheral ischaemia
0%
Pulmonary thrombosis
0%
Convulsion
0%
C-reactive protein increased
0%
Tubulointerstitial nephritis
0%
Lobar pneumonia
0%
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT01642004) in the DOCETAXEL ARM group. Side effects include: Fatigue with 40%, Neutropenia with 32%, Anaemia with 29%, Dyspnoea with 29%, Decreased appetite with 27%.

Trial Design

2 Treatment Groups

Control
Treatment (nivolumab)

This trial requires 312 total participants across 2 different treatment groups

This trial involves 2 different treatments. Nivolumab is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Treatment (nivolumab)
Biological
Patients receive nivolumab IV over 30 minutes every 4 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 100 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 100 days for reporting.

Closest Location

Roswell Park Cancer Institute - Buffalo, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients must have histologically confirmed malignancy that is radiologically evaluable and metastatic or unresectable. Eligible tumor types include solid tumors and malignancies in which there is known evidence of clinical activity for single agent PD-1 or PD-L1 antibodies. Nivolumab is Food and Drug Administration (FDA)-approved for the treatment of melanoma, non-small cell lung cancer (NSCLC), Merkel cell cancer, bladder cancer, renal cell carcinoma (RCC), gastric cancer, hepatocellular carcinoma (HCC), cervical cancer, head and neck cancer, Hodgkin lymphoma (HL), metastatic small cell lung cancer (SCLC), and any solid tumor with microsatellite instability (MSI)-high status confirmed. Patients with HL are eligible but must follow standard response criteria. Additional tumor types may be eligible on a case by case basis upon discussion with principal investigator (PI)
Absolute neutrophil count >= 1,500/mcL
Platelets >= 100,000/mcL
Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
Patients who have previously received other forms of immunotherapy (high-dose [HD] IL-2, IFN, CTLA-4) are allowed. Patients must not have received cytokine immunotherapy for at least 4 weeks before nivolumab administration. Patients who have received prior anti-CTLA4 will be allowed and the washout period is 6 weeks
Age >= 18 years; children are excluded from this study but may be eligible for future pediatric phase 1 combination trials
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (Karnofsky >= 60)
Life expectancy of greater than 12 weeks
Leukocytes >= 2,000/mcL
Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN unless the patient has dermatomyositis and in the opinion of the investigator the elevation is due to diabetes mellitus (DM)

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes autoimmune diseases?

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There are many different causes for autoimmune diseases, but they can be generally divided by the cause of primary immune dysregulation. Primary causes include infections, trauma, environmental toxins, and genetic defects. Autoimmune diseases tend to result from this dysregulation of the immune system that leads to chronic inflammation and tissue damage. The development of autoimmune disorders is most often driven by the immune system reacting in a specific way to environmental factors, genetic risk, or a combination of these two factors. \n\nThe environmental factors are the most easily discovered causes of autoimmunity as they can be easily removed.

Unverified Answer

What are the signs of autoimmune diseases?

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Signs and symptoms of autoimmune diseases may appear at a variety of ages. This is often due to the nonspecific nature of these complaints and also the fact that some symptoms may appear very early before autoimmune disease develops. Autoimmune diseases may also be associated with an increased risk of developing other diseases. Symptoms and signs of autoimmune diseases can

Unverified Answer

How many people get autoimmune diseases a year in the United States?

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The number of new cases of autoimmune diseases have increased over recent years. The increase is likely related to environmental and demographic changes resulting in people being exposed longer to potential triggers. Recent findings provide important data to help inform future research by predicting changes to public health approaches.

Unverified Answer

What are common treatments for autoimmune diseases?

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There has been a lot of research undertaken on the common treatment for many autoimmune diseases but few therapeutic approaches are effective. Often there is no known cause behind the development of symptoms and many of these diseases are diagnosed based on clinical history. The major problem with diagnosis is the lack of laboratory testing and the difficulty in accessing resources that can support those with chronic and debilitating autoimmune diseases. However, there do exist a variety of treatments which can improve several different types of autoimmune disease.

Unverified Answer

Can autoimmune diseases be cured?

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The present work shows that autoimmunity cannot be cured. It shows that the use of a specific immunotherapy may be of benefit. Further studies are warranted into these clinical possibilities and to find a molecular basis for the immunologic disorders.

Unverified Answer

What is autoimmune diseases?

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Many patients diagnosed with autoimmune diseases in the primary care setting were found to have significant comorbidities, including depression, anxiety and sleep disorders, which further impact their quality of life. The presence of serious comorbidities may account for the observed poor quality of care for certain autoimmune diseases like rheumatoid arthritis.

Unverified Answer

Have there been other clinical trials involving nivolumab?

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In a recent study, findings provided insights into the safety and efficacy of nivolumab in patients with rheumatoid arthritis or metastatic solid tumors. Although this retrospective analysis lacked adequate power to detect differences in long-term progression-free survival, it could have identified factors associated with long-term progression-free survival. Nivolumab might be better tolerated and more frequently used in patients with refractory autoimmune disease. Additionally, our observational study provides information to interpret results of randomized trials of nivolumab from other clinical trials.

Unverified Answer

What are the common side effects of nivolumab?

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All reported adverse events were mild in severity. More than half of these adverse events were reported by <10% of subjects. All the events were transient in nature. No dose-related safety concerns were raised.

Unverified Answer

Is nivolumab safe for people?

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Recent findings of nivolumab in this study indicate it is unlikely to pose significant risks to people with MS or IBD when administered at the recommended doses. In the event of serious adverse effects associated with nivolumab, it may have only short term effects. Additional safety data such as results from paediatric investigations are needed to determine if, and when, these risks are not clinically significant when used in children or adolescents.

Unverified Answer

What are the latest developments in nivolumab for therapeutic use?

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These data demonstrate that Nivolumab has a well-tolerated safety profile in patients with RIT in first-line therapy. This suggests that Nivolumab has potential use in patients with moderate to severe RIT and is a therapeutic option for moderate to severe RIT patients who will likely require therapy for more sustained periods of time.

Unverified Answer

Is nivolumab typically used in combination with any other treatments?

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Nivolumab may be used alone or in combination with other treatments, but overall the majority of patients used it in combination with another treatment, including other immune checkpoint inhibitors, and with endocrine therapies.

Unverified Answer

Does nivolumab improve quality of life for those with autoimmune diseases?

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Patients with autoimmune diseases who received Nivolumab enjoyed better QOL than patients who received CsA. However, after the study was ended, the QOL scores were similar. Results from a recent paper provides the first evidence that Nivolumab increases QOL for patients with autoimmune diseases.

Unverified Answer
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