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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 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.

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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.

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 the Registry Record Tells You About NCT04741997

The ClinicalTrials.gov registry entry for NCT04741997 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 100-participant average among 17 other Melanoma Stage IV trials with a reported enrollment target (50% lower). The listed sponsor is H. Lee Moffitt Cancer Center and Research Institute, which has 502 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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