ERASE


ERASE: Evaluation of Response Adapted Stereotactic ablative body radiotherapy (SABR) in advanced mElanoma receiving immunotherapy (ERASE part 1: pilot trial)

Trial summary:

The ERASE study aims to develop a method for using Stereotactic Ablative Radiation Therapy (SABR) that accounts for both the anatomy (the shape and position of the cancer) and the biological response to immunotherapy and demonstrate that this approach is effective in treating metastatic melanoma.

Receptor status / problem studied:

Inclusion criteria

1) 18 years and over.

2) ECOG status 0-2.

3) Receiving first line PD-1 backbone immunotherapy for metastatic melanoma (including PD-1-based monotherapy or combinations with other standard (e.g., anti-CTLA) or novel (e.g., Relatlimab) ICIs).

4) Expected to be suitable for and able to receive SABR if required (physician discretion).

5) All metastases must be radiologically defined targets and be suitable for treatment with SABR in accordance with the dose fractionation options specified in the protocol.

6) Patients with treated and/or asymptomatic brain metastases are eligible for inclusion. Standard of care treatment for brain metastases is permitted.

7) Able to provide informed consent prior.

8) Baseline FDG-PET/CT within 1 month prior to the initiation of ICIs.

9) No more than 5 lesions not achieving a complete metabolic response based on FDG-PET/CT at 3-months post-initiation of ICIs.

10) Able to be enrolled onto the trial within 4 weeks of the 3-month FDG-PET/CT scan.

Exclusion criteria

1) Life expectancy <6 months.

2) Previous adjuvant immunotherapy within 6 months prior to initiation of ICIs.

3) Previous RT to any part of the body except for curative-intent skin cancer or localised prostate cancer delivered at least 2 years prior.

4) Persistent CTCAE grade 3 or 4 toxicity from immunotherapy at 3-months post-initiation of ICIs.

5) Patients unable or unwilling to comply with protocol requirements.

View more trial information

Open for recruitment

Trial Title

ERASE

Diagnosis

Skin cancer – melanoma

Type of trial

Investigator Initiated

Type of treatement

Radiation Oncology

Phase

N/A

Locations

Investigators

Principal Investigator
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