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NCT03816345 · ClinicalTrials.gov registry record · Phase 1
Nivolumab in Treating Patients With Autoimmune Disorders and Advanced, Metastatic, or Unresectable Cancer
A Phase 1 study of Multiple Sclerosis and Rheumatoid Arthritis, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 300
- Enrollment target
- 20
- Study locations
NCT03816345: Recruiting Phase 1 study of Multiple Sclerosis and Rheumatoid Arthritis, sponsored by National Cancer Institute (NCI).
NCT03816345 is a Phase 1 study of Multiple Sclerosis and Rheumatoid Arthritis that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 300 participants, below the 584-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (49% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03816345, a Phase 1 study of Multiple Sclerosis and Rheumatoid Arthritis, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 300 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Will be reported overall and by severity, and dose limiting toxicities will be summarized for all patients and by disease severity cohort.
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 |
What NCT03816345 shows while recruiting
NCT03816345 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 584-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (49% lower).
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.
NCT03816345 names 20 study sites across 7 states, led by Kansas, California, Connecticut.
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.
What interventions are being tested in trial NCT03816345?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Nivolumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03816345?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Multiple Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03816345's enrollment target sits among peer trials
300 56th of 315 higher than 256 of 315 other Multiple Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Sclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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