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NCT06216938 · ClinicalTrials.gov registry record · Early Phase 1
RP1 in Primary Melanoma to Reduce the Risk of Sentinel Lymph Node Metastasis
A Early Phase 1 study of Melanoma, sponsored by Yana Najjar.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT06216938: Recruiting Early Phase 1 study of Melanoma, sponsored by Yana Najjar.
NCT06216938 is a Early Phase 1 study of Melanoma that is actively recruiting participants, run by Yana Najjar. The registered enrollment target is 25 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06216938, a Early Phase 1 study of Melanoma, is actively recruiting participants, sponsored by Yana Najjar.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
This early-phase study will examine Vusolimogene Oderparepvec, a genetically modified oncolytic viral strain of the herpes simplex type 1 (HSV-1) virus, with potential oncolytic, immunostimulating and antineoplastic activities. Upon administration, vusolimogene oderparepvec specifically targets, infects and replicates in tumor cells and does not infect healthy cells. This results in tumor cell lysis and the release of virus particles which infect and replicate within nearby tumor cells, resulting in tumor cel death. The immune system is activated by the released tumor-associated antigens (TAAs) from the tumor cells creating an anti-tumor immune response against the tumor cells, thereby further killing the tumor cells. The virus itself also elicits a tumor-specific systemic immune and cytotoxic T-lymphocyte (CTL) response, thereby killing nearby non-infected tumor cells.
Primary Outcome
Proportion of patients with sentinel lymph node lymph node positivity (disease present in lymph node per pathologic assessment).
Conditions Studied
Interventions
- BIOLOGICAL Vusolimogene oderparepvec (RP1)
Study Locations (1)
Pennsylvania
- UPMC Hillman Cancer Center - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2024-03-07 |
| Est. Completion | 2027-03-31 |
| Phase | Early Phase 1 |
What NCT06216938 shows while recruiting
NCT06216938 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 1 intervention - of which Vusolimogene oderparepvec (RP1) is the first listed.
NCT06216938 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06216938 about?
NCT06216938 is a clinical study titled "RP1 in Primary Melanoma to Reduce the Risk of Sentinel Lymph Node Metastasis". This early-phase study will examine Vusolimogene Oderparepvec, a genetically modified oncolytic viral strain of the herpes simplex type 1 (HSV-1) virus, with potential oncolytic, immunostimulating and antineoplastic activities. Upon administration, vusolimogene oderparepvec specifically targets, inf...
What is the current status of trial NCT06216938?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 25 participants. The study started on 2024-03-07. Estimated completion is 2027-03-31.
What conditions does trial NCT06216938 study?
This clinical trial studies the following conditions: Melanoma.
What interventions are being tested in trial NCT06216938?
The interventions under investigation include: Vusolimogene oderparepvec (RP1) (BIOLOGICAL).
Who is sponsoring clinical trial NCT06216938?
This trial is sponsored by Yana Najjar, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06216938 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06216938's enrollment target sits among peer trials
25 215th of 266 higher than 49 of 266 other Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Melanoma 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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