Clinical Study To Further Evaluate The Efficacy Of Dabrafenib Plus Trametinib In Patients With Rare BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors

Recruiting

• Conditions: Rare Unresectable or Metastatic BRAF V600E Mutation-positive Solid Tumors
• Interventions: Other: Non-investigational

• Registration Number: NCT05868629
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This study is a phase IV, pragmatic single-arm prospective, open label study in pediatric (6 years or older) and adult study participants with rare BRAF V600E mutation-positive unresectable or metastatic solid tumors for whom a decision has already been made to be treated with dabrafenib and trametinib, irrespective of the trial participation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-11
• Study First Submitted QC: 2023-05-11
• Study First Posted: 2023-05-22
• Study Start: 2024-02-06
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-12
• Last Update Posted: 2025-01-14
• Primary Completion: 2028-05-04
• Study Completion: 2028-05-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Study participant with a BRAF V600E mutation-positive solid tumor as confirmed by a local laboratory test;
• At least 1 measurable lesion as defined by RECIST v1.1 per local review;
• Study participant previously not treated with dabrafenib and/or trametinib. Study participants who received dabrafenib and trametinib in the past for the treatment of other malignancies are eligible if treatment has been discontinued for greater than 1 year;
• Ability to provide scans for central imaging review

Exclusion Criteria

• Those with the following tumor types: melanoma, NSCLC, ATC, BTC, glioma and CRC;
• Study participants who have contraindication to receive dabrafenib and/ or trametinib according to the local label;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
dabrafenib plus trametinib	Non-investigational	patients treated with dabrafenib and trametinib

Primary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR)	Approximately 4 years	Proportion of study participants with a best overall confirmed Complete Response (CR) or Partial Response (PR) by independent central review according to RECIST v1.1 or other relevant response criteria.

Secondary Outcome Measures

Name	Time	Method
Duration of response (DOR)	Approximately 4 years	Defined as time from the onset of tumor response until the date of the first documented progressive disease (PD) or death due to any cause.
Clinical benefit rate (CBR)	Approximately 4 years	Defined as the proportion of study participants with a best overall response of CR, PR or stable disease (SD), lasting as per independent central review, for a duration of at least 24 weeks. CR, PR and SD are defined according to RECIST v1.1. or other relevant response criteria.

Trial Locations

Locations (4)

Johns Hopkins University; 🇺🇸 Washington, District of Columbia, United States

Duke Clinical Research Institute; 🇺🇸 Durham, North Carolina, United States

Oncology Hematology Care Inc; 🇺🇸 Cincinnati, Ohio, United States

Sarah Cannon Research Institute; 🇺🇸 Nashville, Tennessee, United States