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NCT03316274 · ClinicalTrials.gov registry record · Early Phase 1
Intra-lesional Nivolumab Therapy for Limited Cutaneous Kaposi Sarcoma
A Early Phase 1 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 12
- Enrollment target
NCT03316274: Completed Early Phase 1 study, sponsored by University of California, San Francisco.
NCT03316274 is a Early Phase 1 study that has completed, run by University of California, San Francisco. The registered enrollment target is 12 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03316274, a Early Phase 1 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
Infection with Kaposi sarcoma herpesvirus (KSHV, or human herpesvirus-8 (HHV-8)) causes Kaposi sarcoma (KS). These virally associated diseases occur more frequently in HIV-infected individuals, but can also be found in HIV-uninfected population. Evolution of immunosuppressive mechanisms presumably plays a permissive role in the development, progression and recurrence of these virus-associated cancers and pre-cancers. Currently, available treatment options for these lesions are imperfect and there is no clear treatment for patients with limited cutaneous Kaposi sarcoma (KS). Radiation and injection of vinblastine both have side effects that may not be acceptable. Nivolumab has been used to treat more extensive KS when given intravenously. To the best of the investigator's knowledge, this is the first study to evaluate the safety of intra-lesional injections of nivolumab in patients with KS.
Primary Outcome
The number of participants with DLTs will defined as treatment-related, grade 3-5 adverse events assessed using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Interventions
- DRUG Nivolumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2018-05-07 |
| Est. Completion | 2021-06-30 |
| Phase | Early Phase 1 |
What the finished NCT03316274 record still lists
NCT03316274 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which Nivolumab is the first listed.
NCT03316274 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03316274 about?
NCT03316274 is a clinical study titled "Intra-lesional Nivolumab Therapy for Limited Cutaneous Kaposi Sarcoma". Infection with Kaposi sarcoma herpesvirus (KSHV, or human herpesvirus-8 (HHV-8)) causes Kaposi sarcoma (KS). These virally associated diseases occur more frequently in HIV-infected individuals, but can also be found in HIV-uninfected population. Evolution of immunosuppressive mechanisms presumably p...
What is the current status of trial NCT03316274?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 12 participants. The study started on 2018-05-07. Estimated completion is 2021-06-30.
What interventions are being tested in trial NCT03316274?
The interventions under investigation include: Nivolumab (DRUG).
Who is sponsoring clinical trial NCT03316274?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03316274's enrollment target sits among peer trials
12 1530th of 2000 higher than 401 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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