Circulating Tumour DNA guidEd Therapy for Stage IIB/C mElanoma After surgiCal resecTION

Sponsor
The Christie NHS Foundation Trust
Study ID
NCT04901988
Phase
PHASE2/PHASE3
Status
Terminated

Conditions

  • Melanoma (Skin)
  • Melanoma, Stage II

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab 10 MG/ML — DRUG
    Eligible patients randomised to Arm B will receive 480 mg nivolumab monotherapy 4 weekly via IV infusion for up to 2 years.

Study Details

The trial is looking for new and better ways to treat melanoma, an aggressive type of skin cancer. Having surgery to remove the melanoma will cure the majority of patients with early stage disease. However, a small percentage of these patients will go on to develop further disease, which may spread to other places in their body. Currently, patients who have been cured of melanoma will have appointments in clinic to check that further disease has not developed or returned and some may also receive regular scans. The trial team has developed a blood test that tells us whether cancer cells are still present or is becoming active after a patient has been 'cured' of melanoma, even if a scan looks normal. The test looks for pieces of DNA in the blood that are known to have come from the cancer, which we call 'circulating tumour DNA', or ctDNA. Patients who have ctDNA in their blood have an extremely high chance of the cancer returning. By using the blood test that we have developed we think that we can identify patients earlier than normal. We think that some of the treatments that are used when melanoma cancer has spread may benefit patients at this earlier stage. We want to see if these patients with ctDNA in their blood, who have a higher risk of their cancer returning or spreading, and receive treatment early have a better response to their cancer compared to those patients who receive treatment when their cancer has returned and it can be seen on a scan. This could mean we would be able to offer patients earlier treatment in the future using just a blood test rather than a scan, while also providing reassurance to those patients that do not have ctDNA in their blood that they do not need treatment and their cancer is not returning.

Key Dates

Start date
Nov 8, 2021
Status verified
Apr 2023
Primary completion
Jan 30, 2023
Completion
Jan 30, 2023

Study Design

Enrollment
8 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Arm A
    In Arm A, patients and clinicians will remain blinded to the ctDNA result and will be managed as per standard of care with regular clinical review and imaging, and treated if they develop evidence of disease recurrence.
  • Experimental: Arm B
    Patients randomised to Arm B will not be blinded to the positive ctDNA result and will be treated with the intervention.

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: From randomisation until death by any cause, assessed up to 84 months. ]

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