Rare Unresectable or Metastatic BRAF V600E Mutation-positive Solid TumorsNCT05868629
Clinical Study To Further Evaluate The Efficacy Of Dabrafenib Plus Trametinib In Patients With Rare BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors
An observational study of Rare Unresectable or Metastatic BRAF V600E Mutation-positive Solid Tumors, run by Novartis Pharmaceuticals at 8 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 100 years
- Conditions the study is for
- Rare Unresectable or Metastatic BRAF V600E Mutation-positive Solid Tumors
- What is being tested?
- Non-investigational
- How many people
- 40 participants
- Where
- 8 sitesUnited States
- Study dates
- 6 Feb 2024to 3 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Study participants diagnosed with a rare BRAF V600E mutation-positive unresectable or metastatic solid tumor, 1 year and older excluding patients with melanoma, Non-Small Cell Lung Cancer, Colorectal Cancer, Anaplastic Thyroid Cancer, Biliary Tract Cancer and glioma, who will be treated with dabrafenib and trametinib.
Who may be able to join
- 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
Who cannot join
- 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;
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
Oncology Hematology Care Inc
Cincinnati, Ohio, 45242
Douglas Hart, Douglas.Hart@usoncology.com
Jayadev Mettu
- Recruiting
Rocky Mountain Cancer Centers
Denver, Colorado, 80218
Sierra Archuleta, sierra.archuleta@usoncology.com
Muath Dawod
- Recruiting
Duke Clinical Research Institute
Durham, North Carolina, 27704
Kim Turnage Scoggins, kim.scoggins@duke.edu
Aman Opneja
- Recruiting
El Paso Texas Oncology
El Paso, Texas, 79902
Nicole Dean, nicole.dean@usoncology.com
Ines Sanchez-Rivera
- Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Brianah Ferby, brianah.ferby@scri.com
Meredith Ann McKean
- Recruiting
Texas Oncology San Antonio
San Antonio, Texas, 78258
Norma Norris, norma.norris@usoncology.com
Angel Mier-Hicks
- Recruiting
Lundquist Inst BioMed at Harbor
Torrance, California, 90509-2910
Steve Yoon, +1 310 222 4107, syoon@lundquist.org
Andrew Gianoukakis
- Recruiting
Johns Hopkins University
Washington D.C., District of Columbia, 20016
Kai Hajos, khajos1@jhmi.edu
Michael Pishvaian
About this study
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.
- Being tested
- Non-investigational
- Keywords
- BRAF, v-raf murine sarcoma viral oncogene homolog B1, dabrafenib, trametinib, tumor agnostic
- Medical subject headings
- Hereditary Sensory and Autonomic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-investigationalOther
Participants obtaining commercial (non-investigational) dabrafenib plus trametinib (i.e. solid formulation or liquid formulation, if approved and commercially available locally) per local guidance or patient access program
| Study group | Role | What they receive |
|---|---|---|
| dabrafenib plus trametinib | patients treated with dabrafenib and trametinib Receives: Other: Non-investigational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
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.
Measured: Approximately 4 years
Secondary outcomes (2)
Duration of response (DOR)
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.
Measured: Approximately 4 years
Clinical benefit rate (CBR)
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.
Measured: Approximately 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start6 Feb 2024
- Primary completion3 Mar 2028 (estimated)
- Study completion3 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rare Unresectable or Metastatic BRAF V600E Mutation-positive Solid TumorsStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05868629
- Sponsor's protocol ID
- CDRB436IIC01
- Status last verified
- Mar 2026
- First submitted
- 11 May 2023
- Last updated
- 1 Apr 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study To Further Evaluate The Efficacy Of Dabrafenib Plus Trametinib In Patients With Rare BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT05868629
- Acronym / sponsor ID
- CDRB436IIC01
- Keywords
- BRAF, v-raf murine sarcoma viral oncogene homolog B1, dabrafenib, trametinib, tumor agnostic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2024 (actual)
- Primary completion
- 3 Mar 2028 (estimated)
- Study completion
- 3 Mar 2028 (estimated)
- First posted
- 22 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dabrafenib plus trametinib | – | Other: Non-investigationalpatients treated with dabrafenib and trametinib |
Who may qualify
- Ages
- 1 year to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study participants diagnosed with a rare BRAF V600E mutation-positive unresectable or metastatic solid tumor, 1 year and older excluding patients with melanoma, Non-Small Cell Lung Cancer, Colorectal Cancer, Anaplastic Thyroid Cancer, Biliary Tract Cancer and glioma, who will be treated with dabrafenib and trametinib.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-investigationalParticipants obtaining commercial (non-investigational) dabrafenib plus trametinib (i.e. solid formulation or liquid formulation, if approved and commercially available locally) per local guidance or patient access program | Other | dabrafenib plus trametinib |
Primary outcome
Overall Response Rate (ORR)
Time frame: 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.
2 secondary outcomes
Duration of response (DOR)
Time frame: Approximately 4 years
Clinical benefit rate (CBR)
Time frame: Approximately 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals contact
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rare Unresectable or Metastatic BRAF V600E Mutation-positive Solid Tumors, run by Novartis Pharmaceuticals at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: Approximately 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.