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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04741997
Other study ID # MCC-20641
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date May 24, 2021
Est. completion date January 2027

Study information

Verified date February 2024
Source H. Lee Moffitt Cancer Center and Research Institute
Contact Krystal Victoria
Phone 813-745-0218
Email Krystal.Victoria@moffitt.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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Study Design


Intervention

Drug:
Encorafenib Pill
Encorafenib 450 mg will be administered orally once per day in continuous 28-day cycles
Binimetinib Pill
Binimetinib 45 mg will be administered orally twice per day in continuous 28-day cycles
Nivolumab
Nivolumab will be administered at a dose of 480 mg IV infusion over 30 minutes every 4 weeks.

Locations

Country Name City State
United States Moffitt Cancer Center Tampa Florida

Sponsors (2)

Lead Sponsor Collaborator
H. Lee Moffitt Cancer Center and Research Institute Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of Disease Relapse Investigators will estimate the rate of disease relapse after neoadjuvant therapy based on pathologic complete response status and postoperative adjuvant therapy within each arm. After surgery up to 24 weeks
Secondary Relapse Free Survival Relapse free survival is defined as time from surgery until disease relapse After surgery up to 24 weeks
Secondary Rate of Pathologic Complete Response Investigators will measure the rate of pathologic complete response after surgery. At 26 weeks
Secondary Rate of Non-Pathologic Complete Response Investigators will measure the rate of non-pathologic complete response after surgery. At 26 weeks
Secondary Overall Response Rate Overall response rate will be measured after neoadjuvant therapy (for participants who have measurable disease per RECIST 1.1 at start of neoadjuvant therapy). Up to 26 weeks
Secondary Overall Survival Overall survival will be measured from time of surgery to death from any cause. After surgery, up to 5 years
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