NCT05868629 Clinical Study To Further Evaluate The Efficacy Of Dabrafenib Plus Trametinib In Patients With Rare BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors
| NCT ID | NCT05868629 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Novartis Pharmaceuticals |
| Condition | Rare Unresectable or Metastatic BRAF V600E Mutation-positive Solid Tumors |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-02-06 |
| Primary Completion | 2028-03-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2024-02-06 with a primary completion date of 2028-03-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is a phase IV, pragmatic single-arm prospective, open label study in pediatric (1 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.
Eligibility Criteria
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;
Contact & Investigator
Novartis Pharmaceuticals
STUDY DIRECTOR
Novartis Pharmaceuticals
Frequently Asked Questions
Who can join the NCT05868629 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 100 Years, studying Rare Unresectable or Metastatic BRAF V600E Mutation-positive Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05868629 currently recruiting?
Yes, NCT05868629 is actively recruiting participants. Contact the research team at novartis.email@novartis.com for enrollment information.
Where is the NCT05868629 trial being conducted?
This trial is being conducted at Torrance, United States, Denver, United States, Washington D.C., United States, Durham, United States and 4 additional locations.
Who is sponsoring the NCT05868629 clinical trial?
NCT05868629 is sponsored by Novartis Pharmaceuticals. The principal investigator is Novartis Pharmaceuticals at Novartis Pharmaceuticals. The trial plans to enroll 40 participants.