Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO
Public ClinicalTrials.gov record NCT03816345. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03816345
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 300 participants
Conditions and interventions
Conditions
Interventions
- Biospecimen Collection Procedure
- Cabozantinib Drug
- Fluoropyrimidine Drug
- Ipilimumab Biological
- Nivolumab Biological
- Platinum Compound Drug
- Platinum Doublet Drug
Procedure · Drug · Biological
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 15, 2019
- Primary completion
- Mar 29, 2028
- Completion
- Mar 29, 2028
- Last update posted
- Jul 30, 2026
2019 – 2028
United States locations
- U.S. sites
- 51
- U.S. states
- 19
- U.S. cities
- 40
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | Birmingham | Alabama | 35233 | Active, not recruiting |
| Stanford Cancer Institute Palo Alto | Palo Alto | California | 94304 | Active, not recruiting |
| University of California Davis Comprehensive Cancer Center | Sacramento | California | 95817 | Recruiting |
| Smilow Cancer Center/Yale-New Haven Hospital | New Haven | Connecticut | 06510 | Recruiting |
| Yale University | New Haven | Connecticut | 06520 | Recruiting |
| MedStar Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | Recruiting |
| Emory University Hospital/Winship Cancer Institute | Atlanta | Georgia | 30322 | Active, not recruiting |
| Northwestern University | Chicago | Illinois | 60611 | Active, not recruiting |
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637 | Active, not recruiting |
| University of Kansas Clinical Research Center | Fairway | Kansas | 66205 | Recruiting |
| HaysMed | Hays | Kansas | 67601 | Recruiting |
| University of Kansas Cancer Center | Kansas City | Kansas | 66160 | Recruiting |
| Lawrence Memorial Hospital | Lawrence | Kansas | 66044 | Recruiting |
| The University of Kansas Cancer Center - Olathe | Olathe | Kansas | 66061 | Recruiting |
| University of Kansas Cancer Center-Overland Park | Overland Park | Kansas | 66210 | Recruiting |
| University of Kansas Hospital-Indian Creek Campus | Overland Park | Kansas | 66211 | Recruiting |
| Mercy Hospital Pittsburg | Pittsburg | Kansas | 66762 | Suspended |
| Salina Regional Health Center | Salina | Kansas | 67401 | Recruiting |
| University of Kansas Health System Saint Francis Campus | Topeka | Kansas | 66606 | Recruiting |
| University of Kansas Hospital-Westwood Cancer Center | Westwood | Kansas | 66205 | Recruiting |
| University of Kentucky/Markey Cancer Center | Lexington | Kentucky | 40536 | Recruiting |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | 21287 | Recruiting |
| National Cancer Institute Developmental Therapeutics Clinic | Bethesda | Maryland | 20892 | Recruiting |
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | Active, not recruiting |
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | Recruiting |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | Recruiting |
| Wayne State University/Karmanos Cancer Institute | Detroit | Michigan | 48201 | Active, not recruiting |
| Siteman Cancer Center at Saint Peters Hospital | City of Saint Peters | Missouri | 63376 | Recruiting |
| Siteman Cancer Center at West County Hospital | Creve Coeur | Missouri | 63141 | Recruiting |
| University Health Truman Medical Center | Kansas City | Missouri | 64108 | Recruiting |
| University of Kansas Cancer Center - North | Kansas City | Missouri | 64154 | Recruiting |
| University of Kansas Cancer Center - Lee's Summit | Lee's Summit | Missouri | 64064 | Recruiting |
| University of Kansas Cancer Center at North Kansas City Hospital | North Kansas City | Missouri | 64116 | Recruiting |
| Washington University School of Medicine | St Louis | Missouri | 63110 | Recruiting |
| Siteman Cancer Center-South County | St Louis | Missouri | 63129 | Recruiting |
| Siteman Cancer Center at Christian Hospital | St Louis | Missouri | 63136 | Recruiting |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | Recruiting |
| NYU Langone Hospital - Long Island | Mineola | New York | 11501 | Recruiting |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York | New York | 10016 | Recruiting |
| NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York | 10032 | Recruiting |
| NYP/Weill Cornell Medical Center | New York | New York | 10065 | Recruiting |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | Recruiting |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | Active, not recruiting |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | Recruiting |
| UT Southwestern Simmons Cancer Center - RedBird | Dallas | Texas | 75237 | Recruiting |
| UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | 75390 | Recruiting |
| UT Southwestern/Simmons Cancer Center-Fort Worth | Fort Worth | Texas | 76104 | Recruiting |
| UT MD Anderson Cancer Center | Houston | Texas | 77030 | Recruiting |
| UT Southwestern Clinical Center at Richardson/Plano | Richardson | Texas | 75080 | Recruiting |
| Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah | 84112 | Active, not recruiting |
| VCU Massey Comprehensive Cancer Center | Richmond | Virginia | 23298 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03816345, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 30, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03816345 live on ClinicalTrials.gov.