Eligibility Details:
Minimum age 18 or as specified in the Product Monograph and eligible for public funding.
Inclusion Criteria:
- Histologically confirmed melanoma that is unresectable / metastatic (stage III or
stage IV).
- Eligible to receive treatment with a government approved and publically-funded PD-1
inhibitor, according to the guidance / indications described in the Product Monograph
/ Provincial Formulary.
- Patients must have evidence of unresectable / metastatic disease, that is considered
evaluable by the investigator and can be followed, but measurable disease is not
mandatory.
- Patients with brain metastases are allowed, provided they are stable according to the
following definitions:
1. Without evidence of progression for at least four weeks prior to randomization
and have no evidence of new or enlarging brain metastases.
2. Treated with surgery and without evidence of progression prior to randomization
and have no evidence of new or enlarging brain metastases.
3. Treated with stereotactic radiosurgery and without evidence of progression prior
to randomization and have no evidence of new or enlarging brain metastases.
- Patient is able (i.e. sufficiently fluent) and willing to complete the quality of life
and health utility questionnaires in either English or French. The baseline assessment
must be completed within required timelines, prior to randomization. Inability (lack
of comprehension in English or French, or other equivalent reason such as cognitive
issues or lack of competency) to complete the questionnaires will not make the patient
ineligible for the study. However, ability but unwillingness to complete the
questionnaires will make the patient ineligible.
- Patient consent must be appropriately obtained in accordance with applicable local and
regulatory requirements. Each patient must sign a consent form prior to enrollment in
the trial to document their willingness to participate.
- Patients must be accessible for treatment and follow-up. Investigators must assure
themselves the patients randomized on this trial will be available for complete
documentation of the treatment, adverse events, and follow-up.
- Patients must be randomized prior to the start of, or within 16 weeks from, the
initiation of PD-1 inhibitor treatment. For patients who are being randomized before
the start of treatment, the PD-1 inhibitor should be started within 5 working days
after randomization.
Exclusion Criteria:
- Patients not willing to stop anti-PD-1 therapy, if randomized to the intermittent arm.
- Patients with any contraindications to PD-1 inhibitors, as described in the Product
Monograph or Provincial Formulary, and/or not eligible to receive anti-PD-1 therapy.
common.study.methods.has-drugs-yes
common.study.methods.is-healthy-yes
