← Back to Search

PD-1 Inhibitor

Nivolumab for Autoimmune Diseases

Phase 1
Waitlist Available
Research Sponsored by Alliance Foundation Trials, LLC.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 months
Awards & highlights

Study Summary

This trial is exploring if a PD-1 inhibitor called Nivolumab is safe and effective in treating autoimmune disease.

Eligible Conditions
  • Autoimmune Diseases
  • Non-Small Cell Lung Cancer
  • Rheumatoid Arthritis
  • Psoriasis
  • Giant Cell Arteritis
  • Polymyalgia Rheumatica
  • Crohn's Disease
  • Multiple Sclerosis
  • Ulcerative Colitis
  • Lupus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose-Limiting Toxicity (DLT)
Secondary outcome measures
Overall Response Rate
Overall Survival
Progression-Free Survival

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%
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%
Dehydration
7%
Hyperglycaemia
7%
Hyperkalaemia
7%
Blood alkaline phosphatase increased
7%
Chills
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%
Small intestinal haemorrhage
1%
Neoplasm progression
1%
Pneumothorax
1%
Atrial flutter
1%
Bone pain
1%
Pericardial effusion malignant
1%
Circulatory collapse
1%
Confusional state
1%
Cancer pain
1%
Hypercalcaemia
1%
Femur fracture
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

2Treatment groups
Experimental Treatment
Group I: Nivolumab: Autoimmune Diseases Cohort 2Experimental Treatment1 Intervention
Arms determined by autoimmune type. Second cohort consists of patients with: Other autoimmune diseases (ulcerative colitis, Crohn's disease, multiple sclerosis). Patients must be discussed with PI prior to enrollment. If a patient has more than one autoimmune condition, if all the conditions are within either cohort 1 or 2 above, the patient will be assigned to that cohort. If the patient has conditions from both cohort 1 and 2, the patient will be grouped in cohort 2.
Group II: Nivolumab: Autoimmune Diseases Cohort 1Experimental Treatment1 Intervention
Arms determined by autoimmune type. First cohort consists of patients with: Rheumatoid arthritis, psoriasis, giant cell arteritis/polymyalgia rheumatica, systemic lupus erythematosis If a patient has more than one autoimmune condition, if all the conditions are within either cohort 1 or 2 above, the patient will be assigned to that cohort. If the patient has conditions from both cohort 1 and 2, the patient will be grouped in cohort 2.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved

Find a Location

Who is running the clinical trial?

Alliance Foundation Trials, LLC.Lead Sponsor
23 Previous Clinical Trials
25,025 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,640 Previous Clinical Trials
4,129,457 Total Patients Enrolled
5 Trials studying Autoimmune Diseases
773 Patients Enrolled for Autoimmune Diseases

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
TrialsJournal
Outcome Measurement in Clinical Trials for Ulcerative Colitis: Towards Standardisation
Cooney, Rachel M, Bryan F Warren, Douglas G Altman, Maria T Abreu, and Simon PL Travis. 2007. “Outcome Measurement in Clinical Trials for Ulcerative Colitis: Towards Standardisation”. Trials. Springer Science and Business Media LLC. doi:10.1186/1745-6215-8-17.
Annals of the Rheumatic DiseasesJournal
A Disease Activity Score for Polymyalgia Rheumatica
Leeb, B F. 2004. “A Disease Activity Score for Polymyalgia Rheumatica”. Annals of the Rheumatic Diseases. BMJ. doi:10.1136/ard.2003.011379.
Journal of the European Academy of Dermatology and VenereologyJournal
What Are the Best Outcome Measures for Assessing Plaque Psoriasis Severity? A Systematic Review of the Literature
Puzenat, E, V Bronsard, S Prey, P-A Gourraud, S Aractingi, M Bagot, B Cribier, et al.. 2010. “What Are the Best Outcome Measures for Assessing Plaque Psoriasis Severity? A Systematic Review of the Literature”. Journal of the European Academy of Dermatology and Venereology. Wiley. doi:10.1111/j.1468-3083.2009.03562.x.
Journal of the European Academy of Dermatology and VenereologyJournal
Comparison of Three Methods for Measuring Psoriasis Severity in Clinical Studies (part 1 of 2): Change During Therapy in Psoriasis Area and Severity Index, Static Physician's Global Assessment and Lattice System Physician's Global Assessment
Chow, C., M.J. Simpson, T.A. Luger, H. Chubb, and C.N. Ellis. 2015. “Comparison of Three Methods for Measuring Psoriasis Severity in Clinical Studies (part 1 of 2): Change During Therapy in Psoriasis Area and Severity Index, Static Physician's Global Assessment and Lattice System Physician's Global Assessment”. Journal of the European Academy of Dermatology and Venereology. Wiley. doi:10.1111/jdv.13132.
~1 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top