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NCT06295159 · ClinicalTrials.gov registry record · Phase 2
Neoadjuvant and Adjuvant Anti-PD1 or Combinations for Locoregionally Advanced Melanoma
A Phase 2 study of Melanoma and Advanced Melanoma, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 90
- Enrollment target
- 1
- Study location
NCT06295159: Recruiting Phase 2 study of Melanoma and Advanced Melanoma, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT06295159 is a Phase 2 study of Melanoma and Advanced Melanoma that is actively recruiting participants, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 90 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06295159, a Phase 2 study of Melanoma and Advanced Melanoma, is actively recruiting participants, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 90 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine if neoadjuvant (treatment before surgery) immunotherapy treatment based on tumor biomarkers results in better participant outcomes. Immunotherapy is the treatment of disease by using a person's own immune system. This study is divided into 2 sub-studies/parts designated Part 1 and Part 2 that will enroll in sequence starting with Part 1 followed by Part 2.
Primary Outcome
The pathologic response rate will be measured by evaluation of the residual viable tumor (RVT). Pathologic Major Response (pMR) is defined as near complete response (pCR) measured as ≤10% RVT + complete response (pCR) measured as 0% RVT.
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG Ipilimumab
- DRUG Nivolumab + Relatlimab
Study Locations (1)
Florida
- Moffitt Cancer Center - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2024-05-17 |
| Est. Completion | 2028-11 |
| Phase | Phase 2 |
What NCT06295159 shows while recruiting
NCT06295159 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (87% lower).
The record links to 4 conditions, with Melanoma appearing as the primary indexed condition, and to 3 interventions - of which Nivolumab is the first listed.
NCT06295159 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT06295159 about?
NCT06295159 is a clinical study titled "Neoadjuvant and Adjuvant Anti-PD1 or Combinations for Locoregionally Advanced Melanoma". The purpose of this study is to determine if neoadjuvant (treatment before surgery) immunotherapy treatment based on tumor biomarkers results in better participant outcomes. Immunotherapy is the treatment of disease by using a person's own immune system. This study is divided into 2 sub-studies/par...
What is the current status of trial NCT06295159?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 90 participants. The study started on 2024-05-17. Estimated completion is 2028-11.
What conditions does trial NCT06295159 study?
This clinical trial studies the following conditions: Melanoma, Advanced Melanoma, Melanoma Stage IV, Melanoma Stage III.
What interventions are being tested in trial NCT06295159?
The interventions under investigation include: Nivolumab (DRUG), Ipilimumab (DRUG), Nivolumab + Relatlimab (DRUG).
Who is sponsoring clinical trial NCT06295159?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06295159 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06295159's enrollment target sits among peer trials
90 118th of 266 higher than 148 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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