Title

DETECTION-2 feasibility: A feasibility trial to assess recruitment rates and ctDNA reporting times for patients with resected stage IIB/IIC/IIIA melanoma

Description

DETECTION-2 Feasibility is a trial in patients with resected stage IIB/IIC/IIIA melanoma, who would under standard of care receive adjuvant drug treatment for one year.

This feasibility study will determine whether patients are willing to be randomised between adjuvant therapy and a ctDNA guided approach and thus, whether recruitment will be sufficient to expand into a Phase 3 study.

In addition, the feasibility study will provide further evidence that we are able to provide the ctDNA results in a timely way to inform clinical decisions.

Objectives

Primary:

• To measure if recruitment rate would support phase 3 trial
• To assess if ctDNA sample results can be returned within 10 working days from the sample being taken

Secondary:

• To compare time to relapse in Arm A vs Arm B
• To compare time to distant metastatic relapse in Arm A vs Arm B
• To compare overall survival rate in Arm A vs Arm B
• To examine the time from randomisation in Arm B to detection of ctDNA
• To examine the number of patients in Arm B with undetectable ctDNA but clinical/radiological relapse and site of their relapse
• To examine the site of local and distant metastatic relapse in both arms
• To examine the adverse events in Arm A vs. Arm B

Trial Design

Patients with stage IIB/IIC/IIIA melanoma, following surgical resection of the tumour, will be randomised to receive standard of care adjuvant drug therapy for 1 year or ctDNA monitoring at regular intervals as define by the protocol for 5 years.

The aim is for at least 50 patients to be recruited over a 12 month period.

Trial Status

Open to recruitment.

Population

50 patients over 16 years old with histological confirmation of cutaneous melanoma - stage IIB, IIC or IIIA. SLNB is highly encouraged to ensure accurate staging but is not mandatory. Complete resection performed within 12 weeks prior to randomisation.? Mutation confirmed in BRAF/NRAS/TERT promoter. No prior immunotherapy, chemotherapy, vaccine therapy or BRAF/MEK targeted therapy.

Funder

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The trial is funded by Cancer Research UK (award reference CRCCTA-Nov23/100005)