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Comparing intermittent and continuous PD-1 inhibitor therapy for metastatic melanoma

A Randomized Phase III Trial of the Duration of Anti-PD-1 Therapy in Metastatic Melanoma

Phase 3 Interventional Canadian Cancer Trials Group · NCT02821013

This study is testing if taking a cancer treatment for melanoma continuously or with breaks works just as well for patients and if the break approach might have fewer side effects.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment614 (estimated)
Ages18 Years and up
SexAll
SponsorCanadian Cancer Trials Group Research network
Drugs / interventionspembrolizumab, nivolumab, immunotherapy
Locations30 sites (Coffs Harbour, New South Wales and 29 other locations)
Trial IDNCT02821013 on ClinicalTrials.gov

What this trial studies

This study aims to compare the effectiveness of intermittent versus continuous administration of PD-1 inhibitors in patients with unresectable or metastatic melanoma. Researchers will evaluate whether both treatment schedules yield similar outcomes in terms of patient survival. The study involves administering a government-approved PD-1 inhibitor either continuously or with breaks, depending on the patient's response. The goal is to determine if an intermittent approach could provide similar benefits while potentially reducing side effects and healthcare costs.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed unresectable or metastatic melanoma.

Not a fit: Patients with melanoma that is resectable or those who do not meet the eligibility criteria for PD-1 inhibitors may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a more flexible treatment regimen that improves patient quality of life and reduces healthcare costs.

How similar studies have performed: While intermittent dosing of PD-1 inhibitors is a novel approach, previous studies have shown the effectiveness of continuous therapy, making this investigation significant.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Coffs Harbour, New South Wales and 29 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Unresectable/Metastatic Melanoma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.