Dr. Marcus Butler
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. Patients who initiate treatment with combination anti-PD-1 and
anti-CTLA-4 therapies who experience toxicity may be randomized at the time prior to
starting single-agent PD-1 inhibitor. Repeat imaging must be done within 50 days
prior to randomization to ensure the patient has no evidence of disease progression
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.