Symptoms and General Pathology

All Conditions

Digestive System Diseases

Musculoskeletal Diseases

Nervous System Diseases

Skin and Connective Tissue Diseases

Mouth and Tooth Diseases

Eye Diseases

Immune System Diseases

Infections

Rare Diseases

Syndrome

Crohn Disease

Colitis

Colitis, Ulcerative

Intestinal Diseases

Inflammatory Bowel Diseases

Ulcer

Dermatomyositis

Sjogren's Syndrome

Arthritis

Arthritis, Psoriatic

Sclerosis

Psoriasis

Multiple Sclerosis

Autoimmune Diseases

Scleroderma, Systemic

Scleroderma, Diffuse

Arthritis, Rheumatoid

Lupus Erythematosus, Systemic

Joint Diseases

Demyelinating Autoimmune Diseases, CNS

Autoimmune Diseases of the Nervous System

Demyelinating Diseases

Rheumatic Diseases

Collagen Diseases

Connective Tissue Diseases

Skin Diseases

Skin Diseases, Papulosquamous

Gastroenteritis

Gastrointestinal Diseases

Spondylarthropathies

Spondylitis

Spondylarthritis

Spinal Diseases

Bone Diseases

Xerostomia

Salivary Gland Diseases

Mouth Diseases

Stomatognathic Diseases

Dry Eye Syndromes

Keratoconjunctivitis Sicca

Lacrimal Apparatus Diseases

Polymyositis

Myositis

Muscular Diseases

Neuromuscular Diseases

Systemic Scleroderma

Spondylarthropathy

Idiopathic Inflammatory Myopathy

Antineoplastic Agents

All Drugs and Chemicals

Nivolumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

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.

Undergo collection of blood, CSF, tissue, stool and urine samples

Biospecimen Collection

Site Public Contact

Surbhi Singhal

Patricia M. LoRusso

Geoffrey T. Gibney

Jeffrey A. Sosman

Walter M. Stadler

Joaquina C. Baranda

Julie R. Brahmer

A P. Chen

Patrick A. Ott

Tanner M. Johanns

Sarah A. Weiss

Janice M. Mehnert

Brian S. Henick

Barbara T. Ma

Yuanquan Yang

Yana Najjar

Hans Hammers

Ecaterina E. Ileana Dumbrava

Andrew Poklepovic

Anna Spreafico

Hussein A Tawbi

This phase Ib trial studies the side effects of nivolumab and to see how well it works in treating patients with autoimmune disorders and cancer that has spread to other places in the body or cannot removed by surgery. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

PRIMARY OBJECTIVE:

I. To assess the overall safety, and toxicities associated with the use of the anti-programmed death 1 (PD-1) antibody nivolumab in patients with varying severity of dermatomyositis (DM)/systemic sclerosis (SSc), rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), inflammatory bowel disease (IBD) (ulcerative colitis \[UC\] and Crohn's disease \[CD\]), multiple sclerosis (MS), Sjogren's syndrome \[SjS\], Psoriasis (PsO)/Psoriatic Arthritis (PsA), and other autoimmune diseases.

SECONDARY OBJECTIVES:

I. To evaluate the efficacy of nivolumab in terms of objective response rates (ORRs), progression-free survival (PFS), and overall survival (OS) in patients with cancer and DM/SSc, RA, SLE, IBD (UC and CD), MS, SjS, PsO/PsA, and other autoimmune diseases.

II. To observe and record anti-tumor activity. III. To propose dosing recommendations for anti-PD-1 antibodies based on the severity of the autoimmune disorder.

IV. To evaluate the impact of nivolumab on the disease severity indices for: DM/SSc, RA, SLE, IBD: UC and CD, not specified (NS), MS, SjS, PsO/PsA.

V. To identify biomarkers of response and toxicity.

OUTLINE:

Patients receive nivolumab intravenously (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, cerebrospinal fluid (CSF), tissue, stool, and urine samples throughout the trial.

After completion of study treatment, patients are followed up for 100 days.

Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer

A Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page

Will be reported overall and by severity, and dose limiting toxicities will be summarized for all patients and by disease severity cohort.

Will be summarized at each time point for each disease severity cohort.

Will be computed along with its associated exact 95% confidence interval for all patients and by disease severity cohort.

Will be summarized and assessed using generalized linear mixed modeling.

Will be compared with gene expression in malignant tissues based on two-sample t-test and Wilcoxon rank sum test. False discovery rate, if appropriate, will be used to control for multiple testing.

The association between demographic and clinical measures of interest with overall response rate and toxicity will be evaluated using logistic regression modeling to identify potential predictors of outcomes.

National Cancer Institute (NCI)

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Behaviors and Mental Disorders

Respiratory Tract (Lung and Bronchial) Diseases

Diseases and Abnormalities at or Before Birth

Neoplasms

Heart and Blood Diseases

Wounds and Injuries

Diabetes Mellitus

Inflammation

Alzheimer Disease

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Osteoporosis

Gout

Brain Neoplasms

Parkinson Disease

Obesity

Heart Failure

Spinal Cord Injuries

Asthma

Stroke

Paralysis

Myocardial Infarction

Hypertension

Heart Diseases

Osteoarthritis

Aneurysm

Lung Neoplasms

Epilepsy

Lung Diseases

Eczema

Angina Pectoris

Angina, Unstable

Peripheral Arterial Disease

Peripheral Vascular Diseases

Liver Diseases

Apnea

Sleep Apnea Syndromes

Heart Defects, Congenital

Headache

Fibrosis

Arrhythmias, Cardiac

Arthritis, Juvenile

Bell Palsy

Facial Paralysis

Motor Neuron Disease

Amyotrophic Lateral Sclerosis

Cystic Fibrosis

Hydrocephalus

Muscular Dystrophies

Fibromyalgia

Myofascial Pain Syndromes

Heart Valve Diseases

Ataxia

Cerebellar Ataxia

Meningitis

Cluster Headache

Alopecia

Alopecia Areata

Tension-Type Headache

Craniocerebral Trauma

Undifferentiated Connective Tissue Diseases

Spondylitis, Ankylosing

Granulomatosis with Polyangiitis

Axial Spondyloarthritis

Polymyalgia Rheumatica

Giant Cell Arteritis

Arteritis

Guillain-Barre Syndrome

Neurocutaneous Syndromes

Polychondritis, Relapsing

Hyperostosis

Hyperostosis, Diffuse Idiopathic Skeletal

Intracranial Aneurysm

Vascular Diseases

Infarction

Parkinsonian Disorders

Ganglion Cysts

Synovial Cyst

Basal Ganglia Diseases

Brain Diseases

Central Nervous System Diseases

Movement Disorders

Synucleinopathies

Shilpa Venkatachalam, PhD

Laura Stradford, MPH

Patient Power is a patient research network and database (registry) to collect prospective information about demographics, self-reported diagnoses and medications, and willingness to participate in research from participants with rheumatoid arthritis (RA), spondyloarthritis (SpA), other musculoskeletal conditions, chronic neurological conditions like migraine, chronic pulmonary conditions like Chronic Obstructive Pulmonary Disease (COPD), asthma, autoimmune dermatological conditions such as psoriasis, and other chronic inflammatory or immune-mediated conditions. In addition, since patients with chronic conditions often have other co-morbidities like cardiovascular health and obesity-related metabolic disorders, these conditions will also be included. Participants will provide information from their smartphones or personal computers. The information will be used by researchers and clinicians to help patients and their providers make better, more informed decisions about treatment of chronic conditions.

Patient Power is a patient research network and database (registry) to collect prospective information about demographics, self-reported diagnoses and medications, and willingness to participate in research from participants with rheumatoid arthritis (RA), spondyloarthritis (SpA), other musculoskeletal conditions, chronic neurological conditions like migraine, chronic pulmonary conditions like Chronic Obstructive Pulmonary Disease (COPD), asthma, autoimmune dermatological conditions such as psoriasis, and other chronic inflammatory or immune-mediated conditions. In addition, since patients with chronic conditions often have other co-morbidities like cardiovascular health and obesity-related metabolic disorders, these conditions will also be included. Participants will provide information from their smartphones or personal computers. The information will be used by researchers and clinicians to help patients and their providers make better, more informed decisions about treatment of chronic conditions.

We have established a governance structure with highly engaged patients and stakeholders who will serve on a Patient Governor Group (PGG) and Research Advisory Board (RAB) to ensure Patient Power participant privacy and transparency about research activities. Online tools and a mobile application at me securely capture patient data. The software tools built include real-time connection to the adaptive version of NIH Patient Reported Outcomes Measurement Information System (PROMIS) instruments capturing patient reported data that minimizes participant burden and allows participants to immediately view their scores if they choose. The Patient Power App runs on both web browsers and smartphones with data stored in the Amazon Web Services (AWS) cloud, not on a participant's smartphone or browser. The App has four key design pillars: (1) Patient engagement, community integration and education by incorporating GHLF bloggers and chronic disease news and social media engagement to the app for education, support and research findings to be shared directly and immediately with those living with registry-eligible chronic conditions; (2) Personal longitudinal health and medication tracking by providing participants' access to their actively contributed patient reported outcome (PRO) and other health-related data (e.g. current and past medications). We will use messaging to encourage participants to regularly update their information, including medication information. For example, we may remind participants to contribute their medication information with the following message: "You don't have any active medications. You can record your medications in Patient Power. By adding your active medications, you will be able to see how your symptoms have changed since starting a new medication. Click here to start entering medications". (3) Health care decision making by allowing App users to share health tracking reports at their discretion with their providers or caregivers; and (4) Research opportunities by providing a platform where an array of new research opportunities can be browsed by participants to combat chronic diseases. The combination of solid governance structure with well-developed policies and procedures, engaged patient community, collaborative relationships with many research partners and our innovatively convenient and mobile approach to data collection make Patient Power a unique and powerful patient-led initiative in chronic disease research.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer	NCT03816345	Autoimmune Dise... Crohn Disease Dermatomyositis Hematopoietic a... Inflammatory Bo... Malignant Solid... Multiple Sclero... Psoriasis Psoriatic Arthr... Rheumatoid Arth... Sjogren Syndrom... Systemic Lupus ... Systemic Sclero... Ulcerative Coli...	Biospecimen Col... Nivolumab	18 Years -	National Cancer Institute (NCI)
PatientSpot Formerly Known as ArthritisPower	NCT03840928	Rheumatoid Arth... Ankylosing Spon... Fibromyalgia Gout Crohn Disease Juvenile Idiopa... Lupus Erythemat... Myositis Osteoarthritis Osteoporosis Psoriasis Psoriatic Arthr... Scleroderma Dermatomyositis Inflammatory Bo... Polymyositis Axial Spondyloa... Diffuse Idiopat... Polymyalgia Rhe... Giant Cell Arte... Temporal Arteri... Wegener Relapsing Polyc... Undifferentiate... Spinal Cord Inj... Alzheimer Disea... Amyotrophic Lat... Ataxia Bell Palsy Brain Tumor Cerebral Aneury... Epilepsy Guillain-Barre ... Headache Head Injury Hydrocephalus Lumbar Disc Dis... Meningitis Multiple Sclero... Muscular Dystro... Neurocutaneous ... Parkinson Disea... Stroke Cluster Headach... Tension-Type He... Chronic Obstruc... Asthma Lung Cancer Cystic Fibrosis Sleep Apnea Eczema Alopecia Chronic Inflamm... Unstable Angina Heart Attack Heart Failure Arrythmia Valve Heart Dis... High Blood Pres... Congenital Hear... Peripheral Arte... Diabetes Chronic Liver D... Obesity		19 Years -	Global Healthy Living Foundation
Spontaneous Coronary Artery Dissection (SCAD) and Autoimmunity	NCT03941184	SCAD Addison Disease Ankylosing Spon... Antiphospholipi... Celiac Disease Crohn Disease Dermatomyositis Polymyositis Guillain-Barre ... Hepatitis, Auto... Graves Disease Hashimoto Thyro... Multiple Sclero... Myasthenia Grav... Pernicious Anem... Polymyalgia Rhe... Primary Biliary... Psoriasis Rheumatoid Arth... Systemic Sclero... Sjögren Syndrom... Systemic Lupus ... Takayasu Arteri... Type 1 Diabetes... Ulcerative Coli... Uveitis Vasculitis Vitiligo Raynaud		18 Years - 110 Years	Mayo Clinic
A Pilot Study of Etanercept in Dermatomyositis	NCT00112385	Dermatomyositis	Etanercept Placebo	18 Years - 65 Years	Brigham and Women's Hospital

Spots Global Cancer Trial Database for dermatomyositis