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

Who is this study for? Adult patients with Metastatic or Unresectable Solid Tumors
What treatments are being studied? Nivolumab
Status: Recruiting
Location: See all (52) locations...
Intervention Type: Procedure, Biological
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Alabama
University of Alabama at Birmingham Cancer Center
ACTIVE_NOT_RECRUITING
Birmingham
California
Stanford Cancer Institute Palo Alto
ACTIVE_NOT_RECRUITING
Palo Alto
University of California Davis Comprehensive Cancer Center
RECRUITING
Sacramento
Connecticut
Smilow Cancer Center/Yale-New Haven Hospital
RECRUITING
New Haven
Yale University
RECRUITING
New Haven
Washington, D.c.
MedStar Georgetown University Hospital
RECRUITING
Washington
Georgia
Emory University Hospital/Winship Cancer Institute
ACTIVE_NOT_RECRUITING
Atlanta
Illinois
Northwestern University
ACTIVE_NOT_RECRUITING
Chicago
University of Chicago Comprehensive Cancer Center
ACTIVE_NOT_RECRUITING
Chicago
Kansas
University of Kansas Clinical Research Center
RECRUITING
Fairway
HaysMed
RECRUITING
Hays
University of Kansas Cancer Center
RECRUITING
Kansas City
Lawrence Memorial Hospital
RECRUITING
Lawrence
The University of Kansas Cancer Center - Olathe
RECRUITING
Olathe
University of Kansas Cancer Center-Overland Park
RECRUITING
Overland Park
University of Kansas Hospital-Indian Creek Campus
RECRUITING
Overland Park
Ascension Via Christi - Pittsburg
SUSPENDED
Pittsburg
Salina Regional Health Center
RECRUITING
Salina
University of Kansas Health System Saint Francis Campus
RECRUITING
Topeka
University of Kansas Hospital-Westwood Cancer Center
RECRUITING
Westwood
Kentucky
University of Kentucky/Markey Cancer Center
RECRUITING
Lexington
Massachusetts
Dana-Farber Cancer Institute
RECRUITING
Boston
Massachusetts General Hospital Cancer Center
RECRUITING
Boston
Maryland
Johns Hopkins University/Sidney Kimmel Cancer Center
RECRUITING
Baltimore
National Cancer Institute Developmental Therapeutics Clinic
RECRUITING
Bethesda
National Institutes of Health Clinical Center
ACTIVE_NOT_RECRUITING
Bethesda
Michigan
Wayne State University/Karmanos Cancer Institute
ACTIVE_NOT_RECRUITING
Detroit
Missouri
Siteman Cancer Center at West County Hospital
RECRUITING
Creve Coeur
University Health Truman Medical Center
RECRUITING
Kansas City
University of Kansas Cancer Center - North
RECRUITING
Kansas City
University of Kansas Cancer Center - Lee's Summit
RECRUITING
Lee's Summit
University of Kansas Cancer Center at North Kansas City Hospital
RECRUITING
North Kansas City
Siteman Cancer Center at Christian Hospital
RECRUITING
Saint Louis
Siteman Cancer Center-South County
RECRUITING
Saint Louis
Washington University School of Medicine
RECRUITING
Saint Louis
Siteman Cancer Center at Saint Peters Hospital
RECRUITING
Saint Peters
New Jersey
Rutgers Cancer Institute of New Jersey
RECRUITING
New Brunswick
New York
NYU Langone Hospital - Long Island
RECRUITING
Mineola
Laura and Isaac Perlmutter Cancer Center at NYU Langone
RECRUITING
New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
RECRUITING
New York
NYP/Weill Cornell Medical Center
RECRUITING
New York
Ohio
Ohio State University Comprehensive Cancer Center
RECRUITING
Columbus
Pennsylvania
Thomas Jefferson University Hospital
ACTIVE_NOT_RECRUITING
Philadelphia
University of Pittsburgh Cancer Institute (UPCI)
RECRUITING
Pittsburgh
Texas
UT Southwestern Simmons Cancer Center - RedBird
RECRUITING
Dallas
UT Southwestern/Simmons Cancer Center-Dallas
RECRUITING
Dallas
UT Southwestern/Simmons Cancer Center-Fort Worth
RECRUITING
Fort Worth
M D Anderson Cancer Center
RECRUITING
Houston
UT Southwestern Clinical Center at Richardson/Plano
RECRUITING
Richardson
Utah
Huntsman Cancer Institute/University of Utah
ACTIVE_NOT_RECRUITING
Salt Lake City
Virginia
Virginia Commonwealth University/Massey Cancer Center
RECRUITING
Richmond
Other Locations
Canada
University Health Network-Princess Margaret Hospital
SUSPENDED
Toronto
Time Frame
Start Date: 2019-07-16
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 300
Treatments
Experimental: Treatment (nivolumab)
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.
Sponsors
Leads: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov