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NCT03816345 | RECRUITING | Autoimmune Disease

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

National Cancer Institute (NCI)

Brief Summary:

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.

Condition or disease

Autoimmune Disease

Crohn Disease

Dermatomyositis

Hematopoietic and Lymphoid Cell Neoplasm

Inflammatory Bowel Disease

Malignant Solid Neoplasm

Multiple Sclerosis

Psoriasis

Psoriatic Arthritis

Rheumatoid Arthritis

Sjogren Syndrome

Systemic Lupus Erythematosus

Systemic Scleroderma

Ulcerative Colitis

Intervention/treatment

Biospecimen Collection

Nivolumab

Phase

PHASE1

Detailed Description:

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 300 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)
Actual Study Start Date : 2019-07-16
Estimated Primary Completion Date : 2026-08-31
Estimated Study Completion Date : 2026-08-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Patients can have either histologically confirmed malignancy that is radiologically evaluable and metastatic or unresectable, or have a malignancy for which a PD-1/PD-L1 inhibitor has been approved in the adjuvant setting. 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). Patients enrolling on the trial for adjuvant use will be restricted to those with histology for which a PD-1/PD-L1 inhibitor has been approved in the adjuvant setting including but not limited to NSCLC, melanoma, RCC, cervical cancer, and bladder cancer
  • * 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 \>= 1,000/mcL
  • * Absolute neutrophil count \>= 500/mcL
  • * Platelets \>= 50,000/mcL
  • * Total bilirubin =\< 2 x institutional upper limit of normal (ULN)
  • * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 5 x institutional ULN or =\< 8 x institutional ULN for patients with liver metastases or an autoimmune disease that is contributing to the elevation of these values
  • * Creatinine ULN OR glomerular filtration rate (GFR) \>= 30 mL/min (if using the Cockcroft-Gault formula)
  • * Human immunodeficiency virus (HIV)-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months are eligible for this trial
  • * If evidence of chronic hepatitis B virus (HBV) infection, HBV viral load must be undetectable on suppressive therapy if indicated
  • * If history of hepatitis C virus (HCV) infection, must be treated with undetectable HCV viral load
  • * Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate central nervous system (CNS) specific treatment is not required and is unlikely to be required for at least 4 weeks (or scheduled assessment after the first cycle of treatment), and a risk-benefit analysis (discussion) by the patient and the investigator favors participation in the clinical trial
  • * The effects of nivolumab on the developing human fetus are unknown. For this reason, women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. WOCBP receiving nivolumab will be instructed to adhere to contraception for a period of 5 months after the last dose of investigational product. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after the last dose of investigational product. Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \[HCG\]) within 24 hours prior to the start of nivolumab. Women must not be breastfeeding. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL. These durations have been calculated using the upper limit of the half-life for nivolumab (25 days) and are based on the protocol requirement that WOCBP use contraception for 5 half-lives plus 30 days, and men who are sexually active with WOCBP use contraception for 5 half-lives plus 90 days. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she (or the participating partner) should inform the treating physician immediately
  • * Ability to understand and the willingness to sign a written informed consent document
  • * Patients with more than one autoimmune disease are eligible. The treating physician would determine which autoimmune disease is dominant and the patient would be treated under that specific cohort
Exclusion Criteria
  • * Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events (AEs) due to agents administered more than 4 weeks earlier have not resolved or stabilized. Palliative (limited-field) radiation therapy (RT) is permitted (2 week washout from start of treatment), if all of the following criteria are met
    • * Repeat imaging demonstrates no new sites of bone metastases
    • * The lesion being considered for palliative radiation is not a target lesion
    • * Patients with prior therapy with an anti-PD-1 or anti-PD-L1
    • * Patients with prior allogeneic hematologic transplant
    • * Patients who are receiving any other anticancer investigational agents
    • * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer

Location Details

NCT03816345

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

ACTIVE NOT RECRUITING

United States, Alabama

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States, 35233

ACTIVE NOT RECRUITING

United States, California

Stanford Cancer Institute Palo Alto

Palo Alto, California, United States, 94304

RECRUITING

United States, California

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States, 95817

RECRUITING

United States, Connecticut

Smilow Cancer Center/Yale-New Haven Hospital

New Haven, Connecticut, United States, 06510

RECRUITING

United States, Connecticut

Yale University

New Haven, Connecticut, United States, 06520

RECRUITING

United States, District of Columbia

MedStar Georgetown University Hospital

Washington, District of Columbia, United States, 20007

ACTIVE NOT RECRUITING

United States, Georgia

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States, 30322

ACTIVE NOT RECRUITING

United States, Illinois

Northwestern University

Chicago, Illinois, United States, 60611

RECRUITING

United States, Illinois

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States, 60637

RECRUITING

United States, Kansas

University of Kansas Clinical Research Center

Fairway, Kansas, United States, 66205

RECRUITING

United States, Kansas

HaysMed

Hays, Kansas, United States, 67601

RECRUITING

United States, Kansas

University of Kansas Cancer Center

Kansas City, Kansas, United States, 66160

RECRUITING

United States, Kansas

Lawrence Memorial Hospital

Lawrence, Kansas, United States, 66044

RECRUITING

United States, Kansas

Olathe Health Cancer Center

Olathe, Kansas, United States, 66061

RECRUITING

United States, Kansas

University of Kansas Cancer Center-Overland Park

Overland Park, Kansas, United States, 66210

RECRUITING

United States, Kansas

University of Kansas Hospital-Indian Creek Campus

Overland Park, Kansas, United States, 66211

RECRUITING

United States, Kansas

Ascension Via Christi - Pittsburg

Pittsburgh, Kansas, United States, 66762

RECRUITING

United States, Kansas

Salina Regional Health Center

Salina, Kansas, United States, 67401

RECRUITING

United States, Kansas

University of Kansas Health System Saint Francis Campus

Topeka, Kansas, United States, 66606

RECRUITING

United States, Kansas

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, United States, 66205

RECRUITING

United States, Maryland

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, United States, 21287

RECRUITING

United States, Maryland

National Cancer Institute Developmental Therapeutics Clinic

Bethesda, Maryland, United States, 20892

RECRUITING

United States, Maryland

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

RECRUITING

United States, Massachusetts

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States, 02114

RECRUITING

United States, Massachusetts

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

ACTIVE NOT RECRUITING

United States, Michigan

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, United States, 48201

RECRUITING

United States, Missouri

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, United States, 63141

RECRUITING

United States, Missouri

University Health Truman Medical Center

Kansas City, Missouri, United States, 64108

RECRUITING

United States, Missouri

University of Kansas Cancer Center - North

Kansas City, Missouri, United States, 64154

RECRUITING

United States, Missouri

University of Kansas Cancer Center - Lee's Summit

Lee's Summit, Missouri, United States, 64064

RECRUITING

United States, Missouri

University of Kansas Cancer Center at North Kansas City Hospital

North Kansas City, Missouri, United States, 64116

RECRUITING

United States, Missouri

Washington University School of Medicine

St. Louis, Missouri, United States, 63110

RECRUITING

United States, Missouri

Siteman Cancer Center-South County

St. Louis, Missouri, United States, 63129

RECRUITING

United States, Missouri

Siteman Cancer Center at Christian Hospital

St. Louis, Missouri, United States, 63136

RECRUITING

United States, Missouri

Siteman Cancer Center at Saint Peters Hospital

Saint Peters, Missouri, United States, 63376

RECRUITING

United States, New Jersey

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States, 08903

RECRUITING

United States, New York

NYU Langone Hospital - Long Island

Mineola, New York, United States, 11501

RECRUITING

United States, New York

Laura and Isaac Perlmutter Cancer Center at NYU Langone

New York, New York, United States, 10016

RECRUITING

United States, New York

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

New York, New York, United States, 10032

RECRUITING

United States, New York

NYP/Weill Cornell Medical Center

New York, New York, United States, 10065

RECRUITING

United States, Ohio

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States, 43210

ACTIVE NOT RECRUITING

United States, Pennsylvania

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States, 19107

RECRUITING

United States, Pennsylvania

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States, 15232

RECRUITING

United States, Texas

UT Southwestern Simmons Cancer Center - RedBird

dallas, Texas, United States, 75237

RECRUITING

United States, Texas

UT Southwestern/Simmons Cancer Center-Dallas

dallas, Texas, United States, 75390

RECRUITING

United States, Texas

UT Southwestern/Simmons Cancer Center-Fort Worth

Fort Worth, Texas, United States, 76104

RECRUITING

United States, Texas

M D Anderson Cancer Center

Houston, Texas, United States, 77030

RECRUITING

United States, Texas

UT Southwestern Clinical Center at Richardson/Plano

Richardson, Texas, United States, 75080

ACTIVE NOT RECRUITING

United States, Utah

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States, 84112

RECRUITING

United States, Virginia

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, United States, 23298

RECRUITING

Canada, Ontario

University Health Network-Princess Margaret Hospital

Toronto, Ontario, Canada, Makhj Qqm