Immunotherapy-induced Colitis: A Comprehensive Review of Epidemiology, Clinical Presentation, Diagnostic Workup, and Management Plan.
Haleh Vaziri, Alla Turshudzhyan, Eric Vecchio
https://pubmed.ncbi.nlm.nih.gov/35470301Actively Recruiting
Phase 1
Age: 18Years +
All Genders
ID03816345
A Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)
Led by National Cancer Institute (NCI) · Updated on 2026-05-13
300
Participants Needed
52
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with autoimmune disorders who also have advanced, metastatic, or unresectable cancer to understand the safety and effectiveness of the immunotherapy drug nivolumab alone or combined with other treatments. These combinations include ipilimumab, cabozantinib, platinum-containing chemotherapy, and fluoropyrimidine. The study focuses on how these therapies affect both the cancer and the autoimmune diseases, aiming to learn about side effects, response rates, and survival. Participants are assigned to one of eleven treatment groups, receiving nivolumab intravenously alone or with other drugs like ipilimumab, chemotherapy, or cabozantinib. Treatments vary by cancer type and stage, with schedules ranging from every 2 to 4 weeks, lasting up to two years for some groups. Alongside treatment, patients provide blood, cerebrospinal fluid, tissue, stool, and urine samples at different times during the trial. During the study, patients undergo regular evaluations to monitor side effects, disease progression, and immune responses. Researchers measure outcomes such as adverse events, changes in autoimmune disease activity, tumor response, and overall survival. After treatment ends, patients are followed for 100 days if stable or every 12 weeks for up to five years if the disease progresses, ensuring long-term monitoring of safety and effectiveness.
CONDITIONS
Brief Title
Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with metastatic or unresectable cancer eligible for PD-1/PD-L1 inhibitor treatment
- Diagnosed with an autoimmune disorder such as dermatomyositis, systemic sclerosis, rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, multiple sclerosis, Sjogren syndrome, psoriasis, or psoriatic arthritis
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Life expectancy greater than 12 weeks
- Adequate blood counts and liver and kidney function
- For women of childbearing potential and men sexually active with such partners, agreement to use effective contraception during and after the trial
- Ability to understand and sign informed consent
- Patients with more than one autoimmune disease may participate, treated under the dominant disease cohort
- Disease-specific criteria apply for autoimmune disorders, such as diagnostic confirmation and stable or controlled disease
You will not qualify if you...
- Chemotherapy or radiotherapy within 2 weeks before the study (6 weeks for certain drugs) or unresolved side effects from previous treatments
- Prior treatment with anti-PD-1 or anti-PD-L1 therapies
- Previous allogeneic hematologic transplant
- Participation in other anticancer investigational drug studies
- Uncontrolled illnesses such as active infections, heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting compliance
- For ulcerative colitis: prior ipilimumab treatment, colectomy, or concurrent primary sclerosing cholangitis
- For Crohn's disease: untreated abscesses, symptomatic strictures, short gut, isolated jejunal disease, prior ipilimumab treatment
- For multiple sclerosis: contraindications to gadolinium-enhanced MRI
- Empiric immunosuppressive treatment without clinical workup for UC or CD
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 2 years depending on treatment arm and disease progression
Participants receive nivolumab and other FDA-approved drugs depending on their assigned arm. Treatment may include nivolumab alone or in combination with ipilimumab, platinum doublet chemotherapy, fluoropyrimidine, cabozantinib, or other agents, administered intravenously or orally on schedules specific to their cancer type and stage. Treatment continues in the absence of disease progression or unacceptable toxicity, for durations ranging from up to 3 months after surgery to up to 2 years.
Regular visits every 2, 3, 4, or 6 weeks depending on treatment regimen
Follow-up
Duration - 100 days to 5 years depending on disease progression
After completing treatment, participants without disease progression are followed for 100 days, and those with disease progression are followed every 12 weeks for up to 5 years to monitor safety and disease status.
Follow-up visits every 12 weeks for up to 5 years for those with disease progression; 1 follow-up period of 100 days for others
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
Loading map...
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
11
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here