Ignite Creation Date:
2024-07-17 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06470880
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-05-13
Brief Title:
Circulating Tumour DNA Guided Adaptive BRAF and MEK Inhibitor Therapy
Sponsor:
The Christie NHS Foundation Trust
Organization:
The Christie NHS Foundation Trust
Study Overview
Official Title:
Circulating Tumour DNA Guided Adaptive BRAF and MEK Inhibitor Therapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DyNAMIc
Brief Summary:
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
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
Detailed Description:
Encorafenib and binimetinib given in combination the treatment is a standard of care treatment in the UK for late stage cutaneous melanoma a skin cancer that starts in the cells that produce skin pigmentation Late stage means it cant be surgically removed or has spread The treatment is taken daily Resistance to the treatment can develop after about 12-15 months During this period the treatment will kill the less resistant cells meaning the tumour has a greater proportion of cells that are resistant to the treatment
This study aims to investigate 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 as a whole less resistant to the treatment and increasing the time it takes for the disease to progress A blood test that measures the amount of tumour DNA circulating in the patients blood known as ctDNA will be conducted every two weeks to check if the cancer cells are still present and if they are becoming active The result of this test will allow doctors to monitor the activity of the tumour and judge when to pause and resume treatment This intermittent treatment is called adaptive therapy The investigators intend to recruit 40 participants with late stage cutaneous melanoma from NHS hospitals in the UK Ten will receive the standard daily treatment and thirty will receive adaptive therapy Patients 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 As well as the fortnightly visits to hospital patients will required to complete EORTC QLQ-C30 and PRO-CTCAE questionnaires in order for their quality of life to be assessed These will be completed before their treatment starts every 12 weeks from when they start treatment and again if their cancer progresses
This study aims to investigate 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 as a whole less resistant to the treatment and increasing the time it takes for the disease to progress A blood test that measures the amount of tumour DNA circulating in the patients blood known as ctDNA will be conducted every two weeks to check if the cancer cells are still present and if they are becoming active The result of this test will allow doctors to monitor the activity of the tumour and judge when to pause and resume treatment This intermittent treatment is called adaptive therapy The investigators intend to recruit 40 participants with late stage cutaneous melanoma from NHS hospitals in the UK Ten will receive the standard daily treatment and thirty will receive adaptive therapy Patients 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 As well as the fortnightly visits to hospital patients will required to complete EORTC QLQ-C30 and PRO-CTCAE questionnaires in order for their quality of life to be assessed These will be completed before their treatment starts every 12 weeks from when they start treatment and again if their cancer progresses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None