Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO (NCT03816345)

🧪 Interventions in This Study

• Cabozantinib (DRUG)
• Fluoropyrimidine (DRUG)
• Ipilimumab (BIOLOGICAL)
• Nivolumab (BIOLOGICAL)
• Platinum Compound (DRUG)
• Platinum Doublet (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. 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, as well as the neoadjuvant or perioperative setting in which such treatment is considered standard of care or has been approved. 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 or other PD1/PD-L1 inhibitors are 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)
2. 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
3. Patients enrolled on the study can receive Nivolumab with other FDA-approved combinations according to the FDA package insert, including, but not limited to ipilimumab, cabozantinib or chemotherapy
4. 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
5. Age \>= 18 years; children are excluded from this study but may be eligible for future pediatric phase 1 combination trials
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (Karnofsky \>= 60)
7. Life expectancy of greater than 12 weeks
8. Leukocytes \>= 1,000/mcL
9. Absolute neutrophil count \>= 500/mcL
10. Platelets \>= 50,000/mcL
11. Total bilirubin =\< 2 x institutional upper limit of normal (ULN)
12. 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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (52 Sites)

Showing the first 25 of 52 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
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia
• Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia
• Northwestern University — Chicago, Illinois
• University of Chicago Comprehensive Cancer Center — Chicago, Illinois
• University of Kansas Clinical Research Center — Fairway, Kansas
• HaysMed — Hays, Kansas
• University of Kansas Cancer Center — Kansas City, Kansas
• Lawrence Memorial Hospital — Lawrence, Kansas
• The University of Kansas Cancer Center - Olathe — Olathe, Kansas
• University of Kansas Cancer Center-Overland Park — Overland Park, Kansas
• University of Kansas Hospital-Indian Creek Campus — Overland Park, Kansas
• Mercy Hospital Pittsburg — Pittsburg, Kansas
• Salina Regional Health Center — Salina, Kansas
• University of Kansas Health System Saint Francis Campus — Topeka, Kansas
• University of Kansas Hospital-Westwood Cancer Center — Westwood, Kansas
• University of Kentucky/Markey Cancer Center — Lexington, Kentucky
• Johns Hopkins University/Sidney Kimmel Cancer Center — Baltimore, Maryland
• National Cancer Institute Developmental Therapeutics Clinic — Bethesda, Maryland
• National Institutes of Health Clinical Center — Bethesda, Maryland
• Massachusetts General Hospital Cancer Center — Boston, Massachusetts

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
• 💵 Compensation indicated: ARM I (MONOTHERAPY): Patients may receive single agent nivolumab intravenously (IV) over 30 minutes every 4 weeks for up to 2 years for patients with metastatic indications, for up to 1 year for ad...

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💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.