OncoMatch/Clinical Trials/NCT03816345
Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer
Is NCT03816345 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Nivolumab for autoimmune disease.
Treatment: Nivolumab — This phase Ib trial studies the side effects of nivolumab and to see how well it works in treating patients with autoimmune disorders and cancer that has spread to other places in the body or cannot removed by surgery. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Multiple Myeloma
Myelodysplastic Syndrome
Chronic Lymphocytic Leukemia
Tumor Agnostic
Disease stage
Metastatic disease required
histologically confirmed malignancy that is radiologically evaluable and metastatic or unresectable
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: allogeneic hematologic transplant
Patients with prior allogeneic hematologic transplant
Lab requirements
Blood counts
Leukocytes >= 1,000/mcL; Absolute neutrophil count >= 500/mcL; Platelets >= 50,000/mcL
Kidney function
Creatinine ULN OR GFR >= 30 mL/min (if using the Cockcroft-Gault formula)
Liver function
Total bilirubin <= 2 x institutional ULN; AST/ALT <= 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
Leukocytes >= 1,000/mcL; Absolute neutrophil count >= 500/mcL; Platelets >= 50,000/mcL; Total bilirubin <= 2 x institutional ULN; AST/ALT <= 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; Creatinine ULN OR 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 →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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