Dabrafenib + Trametinib for Cancer

Recruiting at 7 trial locations

Overseen By Novartis Pharmaceuticals

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Novartis Pharmaceuticals

Must be taking: Dabrafenib, Trametinib

Disqualifiers: Melanoma, NSCLC, ATC, BTC, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: Approximately 4 years

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of combining two drugs, dabrafenib and trametinib, for individuals with certain advanced solid tumors that cannot be surgically removed. The focus is on tumors with a specific genetic change known as the BRAF V600E mutation. The trial seeks participants who have not previously received these drugs, unless it was for a different cancer and occurred over a year ago. Individuals with melanoma, lung cancer, and a few other specific tumor types are not eligible. For those with a BRAF V600E mutation-positive tumor and no prior treatment with these drugs, this trial may be suitable. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, contributing to significant advancements in cancer treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What is the safety track record for dabrafenib and trametinib?

Research has shown that when dabrafenib and trametinib are used together, most people tolerate them well, though some side effects can occur. Patients might experience fever, which is a higher-than-normal body temperature, and hyperpyrexia, an extremely high fever. There is also a chance of tumor progression, where the cancer could grow or spread.

Other safety concerns include the possibility of developing new cancers, bleeding problems, and blood clots. Various studies have tested these drugs, consistently observing these side effects over time, indicating they are common.

Overall, while risks exist, these drugs have been used to help manage certain types of cancer. Discussing potential side effects with a healthcare provider is important to determine if this treatment is suitable. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about dabrafenib plus trametinib because these drugs specifically target the BRAF V600E mutation, a genetic change found in some rare, hard-to-treat cancers. Unlike standard treatments which might not focus on this mutation, this combination therapy directly inhibits the abnormal proteins produced by the mutation, potentially offering a more precise and effective approach. This targeted mechanism may lead to better outcomes for patients with these specific tumor profiles, offering hope for those with few other treatment options.

What is the effectiveness track record for dabrafenib and trametinib in treating rare BRAF V600E mutation-positive unresectable or metastatic solid tumors?

Studies have shown that the combination of dabrafenib and trametinib, which participants in this trial will receive, effectively treats certain cancers with a BRAF V600E mutation. Research indicates that about one-third of patients who begin treatment with this combination survive for five years. This treatment has improved and prolonged survival in melanoma, non-small cell lung cancer, and anaplastic thyroid cancer. Evidence also highlights that patients with BRAF V600E-mutated cancers experience better response and survival outcomes. Overall, dabrafenib plus trametinib has demonstrated significant effectiveness in managing tumors with this specific mutation. ^{6 7 8 9 10}

Who Is on the Research Team?

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Are You a Good Fit for This Trial?

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;

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dabrafenib and trametinib for the treatment of rare BRAF V600E mutation-positive unresectable or metastatic solid tumors

Approximately 4 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dabrafenib Plus Trametinib

How Is the Trial Designed?

Group I: dabrafenib plus trametinib Experimental Treatment 1 Intervention

patients treated with dabrafenib and trametinib

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Citations

1. nejm.org nejm.org/doi/full/10.1056/NEJMoa1904059

Five-Year Outcomes with Dabrafenib plus Trametinib in ... In conclusion, we found that first-line treatment with dabrafenib plus trametinib led to 5-year survival in approximately one third of patients ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0169500224005725

Real-world efficacy of the dabrafenib-trametinib (D-T) ... The dabrafenib-trametinib (D-T) combination was associated with improved and durable OS in patients in phase II. This study (IFCT-2004 BLaDE study) reported ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5819728/

Treatment with combined dabrafenib and trametinib in ... Our findings confirm similar long-term results of clinical trials indicating that that durable survival is achievable with dabrafenib plus trametinib in ...

4. nature.com nature.com/articles/s41598-025-07467-8

A post-marketing surveillance study of dabrafenib and ... Dabrafenib and trametinib combination therapy has shown improved response and survival outcomes in patients with BRAF V600E-mutated NSCLC ...

5. ascopubs.org ascopubs.org/doi/10.1200/EDBK_404770

Dabrafenib/Trametinib as Tissue-Agnostic Therapy for ... Early evidence supported the use of dabrafenib/trametinib combination in melanoma, non–small-cell lung cancer, and anaplastic thyroid cancer. Furthermore, data ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40965359/

Adverse Events Associated With Dabrafenib, Trametinib, ... Dabrafenib was associated with stronger reporting signals for adverse events such as fever, hyperpyrexia, and tumor progression. Trametinib was associated ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/pds.70200

Adverse Events Associated With Dabrafenib, Trametinib ... Dabrafenib was associated with stronger reporting signals for adverse events such as fever, hyperpyrexia, and tumor progression. Trametinib was ...

8. pro.novartis.com pro.novartis.com/uk-en/medicines/oncology/tafinlar-mekinist/melanoma/safety/combi-v-and-combi-d

Pooled COMBI-v and COMBI-d safety data TAFINLAR® (dabrafenib) and MEKINIST® (trametinib). Pooled safety data from the COMBI-v and COMBI-d trials. For UK healthcare professionals only.

9. fda.gov fda.gov/media/166025/download

dabrafenib WR amend 1 Additional safety concerns identified from clinical experience with dabrafenib in combination with trametinib include new primary malignancies, bleeding, venous.

10. ascopubs.org ascopubs.org/doi/10.1200/JCO.2016.34.15_suppl.9534

Pooled analysis of safety over time and link between ... The safety profile of D+T across registration trials is consistent with individual study reports. With long-term treatment, the highest AE rates were observed ...