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NCT04741997 · ClinicalTrials.gov registry record · Early Phase 1

Adjuvant Therapy Based on Pathologic Response After Neoadjuvant Encorafenib Binimetinib in Melanoma

A Early Phase 1 study of Melanoma Stage IV and Melanoma Stage III, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

Recruiting
Registry status
Early Phase 1
Development phase
50
Enrollment target
1
Study location

NCT04741997: Recruiting Early Phase 1 study of Melanoma Stage IV and Melanoma Stage III, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

NCT04741997 is a Early Phase 1 study of Melanoma Stage IV and Melanoma Stage III that is actively recruiting participants, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 50 participants, below the 100-participant average among 17 other Melanoma Stage IV trials with a reported enrollment target (50% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04741997, a Early Phase 1 study of Melanoma Stage IV and Melanoma Stage III, is actively recruiting participants, sponsored by H. Lee Moffitt Cancer Center and Research Institute.

RECRUITING
Registry status
Early Phase 1
Development phase
50 participants
Enrollment target
1
Study location

Study Summary

The purpose of this study is to assess rate of disease relapse and hazard rate of disease relapse after neoadjuvant therapy based on the statuses of pathologic complete response or non-pathologic complete response, and postoperative adjuvant therapy.

Primary Outcome

Investigators will estimate the rate of disease relapse after neoadjuvant therapy based on pathologic complete response status and postoperative adjuvant therapy within each arm.

Interventions

  • DRUG Nivolumab
  • DRUG Encorafenib Pill
  • DRUG Binimetinib Pill

Study Locations (1)

Florida

  • Moffitt Cancer Center - Tampa

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2021-05-24
Est. Completion 2027-07
Phase Early Phase 1

What NCT04741997 shows while recruiting

NCT04741997 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 100-participant average among 17 other Melanoma Stage IV trials with a reported enrollment target (50% lower).

The record links to 3 conditions, with Melanoma Stage IV appearing as the primary indexed condition, and to 3 interventions - of which Nivolumab is the first listed.

NCT04741997 reports a single indexed study location in Florida.

Frequently Asked Questions

What is clinical trial NCT04741997 about?

NCT04741997 is a clinical study titled "Adjuvant Therapy Based on Pathologic Response After Neoadjuvant Encorafenib Binimetinib in Melanoma". The purpose of this study is to assess rate of disease relapse and hazard rate of disease relapse after neoadjuvant therapy based on the statuses of pathologic complete response or non-pathologic complete response, and postoperative adjuvant therapy.

What is the current status of trial NCT04741997?

This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 50 participants. The study started on 2021-05-24. Estimated completion is 2027-07.

What conditions does trial NCT04741997 study?

This clinical trial studies the following conditions: Melanoma Stage IV, Melanoma Stage III, BRAF V600 Mutation.

What interventions are being tested in trial NCT04741997?

The interventions under investigation include: Nivolumab (DRUG), Encorafenib Pill (DRUG), Binimetinib Pill (DRUG).

Who is sponsoring clinical trial NCT04741997?

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 NCT04741997 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Melanoma Stage IV

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 NCT04741997's enrollment target sits among peer trials

50 11th of 17 higher than 7 of 17 other Melanoma Stage IV trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Melanoma Stage IV 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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Source: ClinicalTrials.gov NCT04741997, the US trial registry maintained by the National Library of Medicine. NCT04741997 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.