Circulating Tumour DNA Guided Adaptive BRAF and MEK Inhibitor Therapy

ConditionMelanoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Christie NHS Foundation Trust

About this trial

The goal of this clinical trial is to investigate adaptive therapy in late-stage cutaneous melanoma. The main question it aims to answer are:

If the patient having breaks in their treatment allows the less resistant cells to continue to grow, this would result in a tumour with a lower proportion of resistant cells, making the tumour less resistant to the treatment, an increasing the time it takes for the disease to progress?

Participants will

* Receive their allocated treatment regimen until their cancer progresses, they or their doctor withdraw them from the study, or until the study ends, whichever happens first. * Attend fortnightly visits to hospital. * Complete EORTC QLQ-C30 and PRO-CTCAE questionnaires, prior to treatment, every 12 weeks and at the point of cancer progression, to assess quality of life.

Researchers will compare the adaptive therapy participant arm with a standard of care arm to answer the research question described above.

Eligibility criteria

Qualifiers

Written and informed consent obtained from participant and agreement of participant to comply with the requirements of the study

Histological confirmation of cutaneous melanoma

≥ 18 years of age

Stage III un-resectable/ IV disease

Disqualifiers

Prior systemic targeted BRAF/MEKi therapy for stage IV (metastatic) melanoma (treatment for stage III allowed as long as RFS ≥26 weeks following discontinuation of drugs)

BRAF wild-type malignant melanoma

Metastasis to the brain or leptomeninges

Any contraindication to treatment with encorafenib or binimetinib as per the local Summary of Product Characteristics

Trial design

Treatments tested in this trial

  • Adaptive Therapy
  • Standard of Care

Treatment groups

40 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

The Christie NHS Foundation Trust

Lead sponsor

University of Manchester

Collaborator

University of Liverpool

Collaborator