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Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer
NCT03816345 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- BIOLOGICAL Nivolumab
Study Locations (20)
Kansas
- University of Kansas Clinical Research Center — Fairway
- HaysMed — Hays
- University of Kansas Cancer Center — Kansas City
- Lawrence Memorial Hospital — Lawrence
- The University of Kansas Cancer Center - Olathe — Olathe
- University of Kansas Cancer Center-Overland Park — Overland Park
- University of Kansas Hospital-Indian Creek Campus — Overland Park
- Mercy Hospital Pittsburg — Pittsburg
- Salina Regional Health Center — Salina
- University of Kansas Health System Saint Francis Campus — Topeka
- University of Kansas Hospital-Westwood Cancer Center — Westwood
California
- Stanford Cancer Institute Palo Alto — Palo Alto
- University of California Davis Comprehensive Cancer Center — Sacramento
Connecticut
- Smilow Cancer Center/Yale-New Haven Hospital — New Haven
- Yale University — New Haven
Illinois
- Northwestern University — Chicago
- University of Chicago Comprehensive Cancer Center — Chicago
Alabama
- University of Alabama at Birmingham Cancer Center — Birmingham
District of Columbia
- MedStar Georgetown University Hospital — Washington D.C.
Georgia
- Emory University Hospital/Winship Cancer Institute — Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2019-07-16 |
| Est. Completion | 2028-03-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03816345
The ClinicalTrials.gov registry entry for NCT03816345 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 10 conditions, with Multiple Sclerosis appearing as the primary indexed condition, and to 2 interventions — of which Biospecimen Collection is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03816345 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Kansas, California, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03816345 about?
NCT03816345 is a clinical study titled "Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer". 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 ...
What is the current status of trial NCT03816345?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 300 participants. The study started on 2019-07-16. Estimated completion is 2028-03-30.
What conditions does trial NCT03816345 study?
This clinical trial studies the following conditions: Multiple Sclerosis, Rheumatoid Arthritis, Malignant Solid Neoplasm, Psoriasis, Hematopoietic and Lymphoid Cell Neoplasm. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03816345?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Nivolumab (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03816345?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03816345 being conducted?
This trial has 20 study locations across Alabama, California, Connecticut, District of Columbia, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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