OncoMatch/Clinical Trials/NCT03816345
Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO
Official title: A Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)
Is NCT03816345 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1 trial studies multiple treatments for autoimmune disease.
Treatment: Cabozantinib · Fluoropyrimidine · Ipilimumab · Nivolumab · Platinum Compound · Platinum Doublet — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Other
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Multiple Myeloma
Myelodysplastic Syndrome
Chronic Lymphocytic Leukemia
Tumor Agnostic
Biomarker criteria
Allowed: PD-L1 (CD274) expression
malignancy for which a PD-1/PD-L1 inhibitor has been approved
Allowed: MSI high
any solid tumor with microsatellite instability (MSI)-high status confirmed
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: anti-PD-1 therapy
Patients with prior therapy with an anti-PD-1 or anti-PD-L1
Cannot have received: anti-PD-L1 therapy
Patients with prior therapy with an anti-PD-1 or anti-PD-L1
Cannot have received: allogeneic hematologic transplant
Patients with prior allogeneic hematologic transplant
Cannot have received: investigational agent
Patients who are receiving any other anticancer investigational agents
Cannot have received: ipilimumab (ipilimumab)
UC-SPECIFIC EXCLUSION: Patients who have received ipilimumab treatment
Cannot have received: ipilimumab (ipilimumab)
CD-SPECIFIC EXCLUSION: Patients who have received ipilimumab treatment
Lab requirements
Blood counts
Leukocytes ≥ 1,000/mcL; Absolute neutrophil count ≥ 500/mcL; Platelets ≥ 50,000/mcL
Kidney function
Creatinine ULN OR glomerular filtration rate (GFR) ≥ 30 mL/min (if using the Cockcroft-Gault formula)
Liver function
Total bilirubin ≤ 2 x institutional upper limit of normal (ULN); AST/ALT ≤ 5 x ULN or ≤ 8 x ULN for patients with liver metastases or an autoimmune disease that is contributing to the elevation of these values
Leukocytes ≥ 1,000/mcL; Absolute neutrophil count ≥ 500/mcL; Platelets ≥ 50,000/mcL; Total bilirubin ≤ 2 x institutional upper limit of normal (ULN); AST/ALT ≤ 5 x ULN or ≤ 8 x 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)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham Cancer Center · Birmingham, Alabama
- Stanford Cancer Institute Palo Alto · Palo Alto, California
- University of California Davis Comprehensive Cancer Center · Sacramento, California
- Smilow Cancer Center/Yale-New Haven Hospital · New Haven, Connecticut
- Yale University · New Haven, Connecticut
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT03816345 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-PD-1 therapy, anti-PD-L1 therapy, allogeneic hematologic transplant disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify