Actively Recruiting
Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
300
Participants Needed
52
Research Sites
454 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase Ib trial studies the side effects of nivolumab and to see how well it works alone and in combination with other treatments, such as ipilimumab, cabozantinib, platinum containing therapy, and fluoropyrimidine, in treating patients with autoimmune disorders and cancer that has spread from where it first started (primary site) to nearby tissue, lymph nodes, or distant parts of the body (advanced), to other places in the body (metastatic) or cannot removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib blocks certain proteins, which may help keep tumor cells from growing. It may also prevent the growth of new blood vessels that tumors need to grow. Cabozantinib is a type of tyrosine kinase inhibitor and a type of angiogenesis inhibitor. Chemotherapy drugs, such as platinum containing therapies and fluoropyrimidine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab alone and in combination with other treatments, including ipilimumab, cabozantinib, platinum containing therapy, or fluoropyrimidine, may be safe, tolerable, and/or effective in treating patients with autoimmune disorders and advanced, metastatic, or unresectable cancer.
CONDITIONS
Official Title
Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with histologically confirmed metastatic or unresectable malignancy or eligible for PD-1/PD-L1 inhibitors in adjuvant/neoadjuvant settings
- Tumor types include melanoma, NSCLC, Merkel cell, bladder, RCC, gastric, HCC, cervical, head and neck, Hodgkin lymphoma, SCLC, MSI-high solid tumors
- Patients may receive nivolumab alone or with FDA-approved combinations like ipilimumab, cabozantinib, or chemotherapy
- Prior immunotherapy allowed with specified washout periods
- Age 18 years or older
- ECOG performance status 0 to 2 (Karnofsky ≥ 60)
- Life expectancy greater than 12 weeks
- Adequate blood counts and organ function
- HIV patients on effective therapy with undetectable viral load eligible
- Controlled hepatitis B or C infection as specified
- Patients with stable or controlled brain metastases eligible
- Use of effective contraception for women of childbearing potential and men
- Ability to understand and sign consent
- Patients with more than one autoimmune disease allowed, treated under dominant disease cohort
- Disease-specific criteria for dermatomyositis/systemic sclerosis, rheumatoid arthritis, lupus, ulcerative colitis, Crohn's disease, multiple sclerosis, Sjogren's syndrome, psoriasis/psoriatic arthritis as detailed in protocol
You will not qualify if you...
- Chemotherapy or radiotherapy within 2 weeks before study entry (6 weeks for certain drugs) or unresolved adverse events from prior treatments
- Prior anti-PD-1 or anti-PD-L1 therapy
- Prior allogeneic hematologic transplant
- Receiving other investigational anticancer agents
- Uncontrolled illness including active infection, heart failure, unstable angina, arrhythmia, psychiatric illness limiting study compliance
- Ulcerative colitis patients previously treated with ipilimumab, prior colectomy, primary sclerosing cholangitis, or empiric immunosuppressive treatment without workup
- Crohn's disease patients with untreated abscesses, symptomatic strictures, short gut physiology, isolated jejunal disease, prior ipilimumab treatment, or empiric immunosuppressive treatment without workup
- Multiple sclerosis patients with contraindications to gadolinium-enhanced MRI
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 52 locations
1
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
Active, Not Recruiting
2
Stanford Cancer Institute Palo Alto
Palo Alto, California, United States, 94304
Active, Not Recruiting
3
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
4
Smilow Cancer Center/Yale-New Haven Hospital
New Haven, Connecticut, United States, 06510
Actively Recruiting
5
Yale University
New Haven, Connecticut, United States, 06520
Actively Recruiting
6
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
7
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Active, Not Recruiting
8
Northwestern University
Chicago, Illinois, United States, 60611
Active, Not Recruiting
9
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
Active, Not Recruiting
10
University of Kansas Clinical Research Center
Fairway, Kansas, United States, 66205
Actively Recruiting
11
HaysMed
Hays, Kansas, United States, 67601
Actively Recruiting
12
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
13
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Actively Recruiting
14
The University of Kansas Cancer Center - Olathe
Olathe, Kansas, United States, 66061
Actively Recruiting
15
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, United States, 66210
Actively Recruiting
16
University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas, United States, 66211
Actively Recruiting
17
Mercy Hospital Pittsburg
Pittsburg, Kansas, United States, 66762
Suspended
18
Salina Regional Health Center
Salina, Kansas, United States, 67401
Actively Recruiting
19
University of Kansas Health System Saint Francis Campus
Topeka, Kansas, United States, 66606
Actively Recruiting
20
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States, 66205
Actively Recruiting
21
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States, 40536
Actively Recruiting
22
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
23
National Cancer Institute Developmental Therapeutics Clinic
Bethesda, Maryland, United States, 20892
Actively Recruiting
24
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Active, Not Recruiting
25
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Actively Recruiting
26
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
27
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Active, Not Recruiting
28
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, United States, 63376
Actively Recruiting
29
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States, 63141
Actively Recruiting
30
University Health Truman Medical Center
Kansas City, Missouri, United States, 64108
Actively Recruiting
31
University of Kansas Cancer Center - North
Kansas City, Missouri, United States, 64154
Actively Recruiting
32
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, United States, 64064
Actively Recruiting
33
University of Kansas Cancer Center at North Kansas City Hospital
North Kansas City, Missouri, United States, 64116
Actively Recruiting
34
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
35
Siteman Cancer Center-South County
St Louis, Missouri, United States, 63129
Actively Recruiting
36
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, United States, 63136
Actively Recruiting
37
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
38
NYU Langone Hospital - Long Island
Mineola, New York, United States, 11501
Actively Recruiting
39
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York, New York, United States, 10016
Actively Recruiting
40
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
Actively Recruiting
41
NYP/Weill Cornell Medical Center
New York, New York, United States, 10065
Actively Recruiting
42
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
43
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Active, Not Recruiting
44
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
45
UT Southwestern Simmons Cancer Center - RedBird
Dallas, Texas, United States, 75237
Actively Recruiting
46
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States, 75390
Actively Recruiting
47
UT Southwestern/Simmons Cancer Center-Fort Worth
Fort Worth, Texas, United States, 76104
Actively Recruiting
48
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
49
UT Southwestern Clinical Center at Richardson/Plano
Richardson, Texas, United States, 75080
Actively Recruiting
50
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
Active, Not Recruiting
51
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
52
University Health Network-Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Suspended
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
11
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