DETERMINE Trial Treatment Arm 07: Dabrafenib in Combination With Trametinib in Adult, Paediatric and Teenage/Young Adult Patients With BRAF V600 Mutation-Positive Cancers.

Sponsor
Cancer Research UK
Study ID
NCT07440290
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

  • Cancer
  • Carcinoma, Non-Small Cell-Lung
  • Colorectal Neoplasms
  • Erdheim-Chester Disease
  • Gastrointestinal Cancer
  • Glioma
  • Haematological Malignancy
  • Langerhans Cell Histiocytosis (LCH)
  • Laryngeal Neoplasms
  • Lymphoproliferative Disorders
  • Malignant Neoplasm
  • Multiple Myeloma
  • Neoplasms by Histologic Type
  • Neoplasms by Site
  • Non-Melanoma Skin Cancer (NMSC)
  • Ovarian Neoplasms
  • Solid Tumour
  • Thyroid Carcinoma, Anaplastic
  • Thyroid Carcinoma, Papillary

Eligibility Criteria

Sex
ALL
Age
1 Year - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dabrafenib — DRUG
    Adult patients (≥18 years) will receive dabrafenib at a dose of 150 mg (two 75 mg tablets) twice daily (total daily dose 300 mg) throughout each 28-day cycle. Paediatric patients (1 to \<12 years) will receive dabrafenib dose adjusted by body weight as 10 mg dispersible tablets orally twice daily throughout each 28-day cycle. Paediatric patients (12-15 years) and TYA patients (16 to \<18 years) will have the option to receive adult or paediatric dosing. Patients may continue until disease progression without clinical benefit, unacceptable AEs or withdrawal of consent.
  • Trametinib — DRUG
    Adult patients (≥18 years) will receive trametinib at a daily dose of 2 mg (one 2 mg tablet) orally once daily (total daily dose 2 mg) throughout the 28-day cycle. Paediatric patients (1 to \<12 years) receive trametinib at a dose adjusted by body weight as 0.05 mg/m\^2 powder for oral solution once daily throughout each 28-day cycle. Paediatric patients (12-15 years) and TYA patients (16 to \<18 years) will have the option to receive adult or paediatric dosing. Patients may continue until disease progression without clinical benefit, unacceptable toxicity or withdrawal of consent.

Study Details

This clinical trial is looking at two drugs called dabrafenib and trametinib. Dabrafenib and trametinib are approved as standard of care treatment for adult patients with melanoma (a type of skin cancer) or lung cancer and in children with glioma (a type of brain tumour). This means they have gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Dabrafenib and trametinib work in patients with a particular mutation in their cancer known as BRAF V600. Investigators now wish to find out if they will be useful in treating patients with other cancer types which have the same mutation. If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future. This trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.

Key Dates

Start date
Feb 28, 2026
Status verified
Feb 2026
Primary completion
Oct 31, 2029
Completion
Oct 31, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm 07: Dabrafenib and Trametinib
    This dabrafenib and trametinib treatment arm is for adult, paediatric and TYA patients with cancers harbouring BRAF V600 mutations.

Primary Outcome Measure

Objective response (OR) [ Time Frame: Disease assessments to be performed up to 24 weeks from the start of trial treatment. ]

Central Contacts

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