Psoriasis Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Psoriasis

Phase:

Phase 1

Estimated Enrollment:

300

Study ID:

NCT03816345

Recruitment Status:

Recruiting

Sponsor:

National Cancer Institute (NCI)

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There are 49 Locations for this study

See Locations Near You

University of Alabama at Birmingham Cancer Center
Birmingham Alabama, 35233, United States
Stanford Cancer Institute Palo Alto
Palo Alto California, 94304, United States
University of California Davis Comprehensive Cancer Center
Sacramento California, 95817, United States More Info
Site Public Contact
Contact
916-734-3089
Surbhi Singhal
Principal Investigator
Smilow Cancer Center/Yale-New Haven Hospital
New Haven Connecticut, 06510, United States More Info
Site Public Contact
Contact
203-785-5702
[email protected]
Patricia M. LoRusso
Principal Investigator
Yale University
New Haven Connecticut, 06520, United States More Info
Site Public Contact
Contact
203-785-5702
[email protected]
Patricia M. LoRusso
Principal Investigator
MedStar Georgetown University Hospital
Washington District of Columbia, 20007, United States More Info
Site Public Contact
Contact
202-444-2223
Geoffrey T. Gibney
Principal Investigator
Emory University Hospital/Winship Cancer Institute
Atlanta Georgia, 30322, United States
Northwestern University
Chicago Illinois, 60611, United States More Info
Site Public Contact
Contact
312-695-1301
[email protected]
Jeffrey A. Sosman
Principal Investigator
University of Chicago Comprehensive Cancer Center
Chicago Illinois, 60637, United States More Info
Site Public Contact
Contact
773-702-8222
[email protected]
Walter M. Stadler
Principal Investigator
University of Kansas Clinical Research Center
Fairway Kansas, 66205, United States More Info
Site Public Contact
Contact
913-588-3671
[email protected]
Joaquina C. Baranda
Principal Investigator
HaysMed
Hays Kansas, 67601, United States More Info
Site Public Contact
Contact
785-623-5774
Joaquina C. Baranda
Principal Investigator
University of Kansas Cancer Center
Kansas City Kansas, 66160, United States More Info
Site Public Contact
Contact
913-588-3671
[email protected]
Joaquina C. Baranda
Principal Investigator
Lawrence Memorial Hospital
Lawrence Kansas, 66044, United States More Info
Site Public Contact
Contact
785-505-2800
[email protected]
Joaquina C. Baranda
Principal Investigator
Olathe Health Cancer Center
Olathe Kansas, 66061, United States More Info
Site Public Contact
Contact
913-355-8000
[email protected]
Joaquina C. Baranda
Principal Investigator
University of Kansas Cancer Center-Overland Park
Overland Park Kansas, 66210, United States More Info
Site Public Contact
Contact
913-588-3671
[email protected]
Joaquina C. Baranda
Principal Investigator
University of Kansas Hospital-Indian Creek Campus
Overland Park Kansas, 66211, United States More Info
Site Public Contact
Contact
913-588-3671
[email protected]
Joaquina C. Baranda
Principal Investigator
Ascension Via Christi - Pittsburg
Pittsburg Kansas, 66762, United States More Info
Site Public Contact
Contact
620-235-7900
[email protected]
Joaquina C. Baranda
Principal Investigator
Salina Regional Health Center
Salina Kansas, 67401, United States More Info
Site Public Contact
Contact
785-452-7038
[email protected]
Joaquina C. Baranda
Principal Investigator
University of Kansas Health System Saint Francis Campus
Topeka Kansas, 66606, United States More Info
Site Public Contact
Contact
785-295-8000
Joaquina C. Baranda
Principal Investigator
University of Kansas Hospital-Westwood Cancer Center
Westwood Kansas, 66205, United States More Info
Site Public Contact
Contact
913-588-3671
[email protected]
Joaquina C. Baranda
Principal Investigator
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore Maryland, 21287, United States More Info
Site Public Contact
Contact
410-955-8804
[email protected]
Julie R. Brahmer
Principal Investigator
National Cancer Institute Developmental Therapeutics Clinic
Bethesda Maryland, 20892, United States More Info
Site Public Contact
Contact
800-411-1222
A P. Chen
Principal Investigator
National Institutes of Health Clinical Center
Bethesda Maryland, 20892, United States More Info
Site Public Contact
Contact
800-411-1222
A P. Chen
Principal Investigator
Massachusetts General Hospital Cancer Center
Boston Massachusetts, 02114, United States More Info
Site Public Contact
Contact
877-726-5130
Patrick A. Ott
Principal Investigator
Dana-Farber Cancer Institute
Boston Massachusetts, 02215, United States More Info
Site Public Contact
Contact
877-442-3324
Patrick A. Ott
Principal Investigator
Wayne State University/Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Siteman Cancer Center at West County Hospital
Creve Coeur Missouri, 63141, United States More Info
Site Public Contact
Contact
800-600-3606
[email protected]
Tanner M. Johanns
Principal Investigator
University Health Truman Medical Center
Kansas City Missouri, 64108, United States More Info
Site Public Contact
Contact
816-404-4375
Joaquina C. Baranda
Principal Investigator
University of Kansas Cancer Center - North
Kansas City Missouri, 64154, United States More Info
Site Public Contact
Contact
913-588-3671
[email protected]
Joaquina C. Baranda
Principal Investigator
University of Kansas Cancer Center - Lee's Summit
Lee's Summit Missouri, 64064, United States More Info
Site Public Contact
Contact
913-588-3671
[email protected]
Joaquina C. Baranda
Principal Investigator
University of Kansas Cancer Center at North Kansas City Hospital
North Kansas City Missouri, 64116, United States More Info
Site Public Contact
Contact
913-588-3671
[email protected]
Joaquina C. Baranda
Principal Investigator
Washington University School of Medicine
Saint Louis Missouri, 63110, United States More Info
Site Public Contact
Contact
800-600-3606
[email protected]
Tanner M. Johanns
Principal Investigator
Siteman Cancer Center-South County
Saint Louis Missouri, 63129, United States More Info
Site Public Contact
Contact
800-600-3606
[email protected]
Tanner M. Johanns
Principal Investigator
Siteman Cancer Center at Christian Hospital
Saint Louis Missouri, 63136, United States More Info
Site Public Contact
Contact
800-600-3606
[email protected]
Tanner M. Johanns
Principal Investigator
Siteman Cancer Center at Saint Peters Hospital
Saint Peters Missouri, 63376, United States More Info
Site Public Contact
Contact
800-600-3606
[email protected]
Tanner M. Johanns
Principal Investigator
Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08903, United States More Info
Site Public Contact
Contact
732-235-7356
Sarah A. Weiss
Principal Investigator
NYU Langone Hospital - Long Island
Mineola New York, 11501, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York New York, 10016, United States More Info
Site Public Contact
Contact
[email protected]
Janice M. Mehnert
Principal Investigator
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York New York, 10032, United States More Info
Site Public Contact
Contact
212-342-5162
[email protected]
Brian S. Henick
Principal Investigator
NYP/Weill Cornell Medical Center
New York New York, 10065, United States More Info
Site Public Contact
Contact
212-746-1848
Barbara T. Ma
Principal Investigator
Ohio State University Comprehensive Cancer Center
Columbus Ohio, 43210, United States More Info
Site Public Contact
Contact
800-293-5066
[email protected]
Yuanquan Yang
Principal Investigator
Thomas Jefferson University Hospital
Philadelphia Pennsylvania, 19107, United States
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh Pennsylvania, 15232, United States More Info
Site Public Contact
Contact
412-647-8073
Yana Najjar
Principal Investigator
UT Southwestern Simmons Cancer Center - RedBird
Dallas Texas, 75237, United States More Info
Site Public Contact
Contact
214-648-7097
[email protected]
Hans Hammers
Principal Investigator
UT Southwestern/Simmons Cancer Center-Dallas
Dallas Texas, 75390, United States More Info
Site Public Contact
Contact
214-648-7097
[email protected]
Hans Hammers
Principal Investigator
UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth Texas, 76104, United States More Info
Site Public Contact
Contact
214-648-7097
[email protected]
Hans Hammers
Principal Investigator
M D Anderson Cancer Center
Houston Texas, 77030, United States More Info
Site Public Contact
Contact
877-632-6789
[email protected]
Ecaterina E. Ileana Dumbrava
Principal Investigator
UT Southwestern Clinical Center at Richardson/Plano
Richardson Texas, 75080, United States More Info
Site Public Contact
Contact
972-669-7044
[email protected]
Hans Hammers
Principal Investigator
Huntsman Cancer Institute/University of Utah
Salt Lake City Utah, 84112, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond Virginia, 23298, United States More Info
Site Public Contact
Contact
[email protected]
Andrew Poklepovic
Principal Investigator
University Health Network-Princess Margaret Hospital
Toronto Ontario, M5G 2, Canada More Info
Site Public Contact
Contact
416-946-4501
[email protected]
Anna Spreafico
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 1

Estimated Enrollment:

300

Study ID:

NCT03816345

Recruitment Status:

Recruiting

Sponsor:


National Cancer Institute (NCI)

How clear is this clinincal trial information?

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